SAE
14 years ago
Sanofi-aventis Successfully Completes Exchange Offer for Genzyme Corporation
Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) announced today that it has successfully completed its exchange offer for all outstanding shares of common stock of Genzyme Corporation (NASDAQ: GENZ).
The exchange offer and withdrawal rights expired at 11:59 p.m., New York City time, on April 1, 2011. The depositary for the exchange offer has advised sanofi-aventis that, as of the expiration time, 224,528,469 shares of Genzyme common stock (including 43,285,259 shares subject to guarantees of delivery) were validly tendered and not withdrawn. That represents approximately 84.6% of Genzyme's outstanding shares of common stock and approximately 77.0% of the shares on a fully-diluted basis, giving sanofi-aventis control of Genzyme. All shares that were validly tendered and not validly withdrawn have been accepted for purchase, and payment for such shares will be made promptly in accordance with the terms of the exchange offer at the offer price of $74.00 in cash, without interest and less any required withholding taxes, and one contingent value right per share. The CVRs have been listed on the NASDAQ stock market under the ticker symbol "GCVRZ" and will begin trading today.
To allow remaining Genzyme shareholders the opportunity to tender their shares, sanofi-aventis has also announced the opening of a subsequent offer period beginning today, April 4, 2011, as contemplated by the merger agreement. The subsequent offer period will expire at 6:00 p.m., New York City time on Thursday, April 7, 2011.
Through the acquisition, Genzyme will become an important new platform in sanofi-aventis' sustainable growth strategy and expand the company's presence in biotechnology. Sanofi-aventis is making Genzyme its global center for excellence in rare diseases and the acquisition will reinforce sanofi-aventis' commitment to the greater Boston area, where it already has a sizeable presence.
"The addition of Genzyme represents an important milestone in sanofi-aventis' sustainable growth strategy by adding a meaningful new growth platform and expanding our footprint in biotechnology," said Christopher A. Viehbacher, Chief Executive Officer of sanofi-aventis. "Combined, our two companies will bring tremendous expertise, commitment and resources to biotechnology, particularly in rare diseases, along with similar cultural traits, including patient-centric missions and strong commitments to the communities we serve. Already, we are making progress on the tremendous opportunities that are possible by bringing these two companies together through the integration process, which is progressing well and remains on track."
"The process we have started with sanofi-aventis has confirmed the enormous opportunities that exist by combining our two companies," said Henri A. Termeer, outgoing Chairman of the Board, President and Chief Executive Officer of Genzyme Corporation. "This moment is a catalyst for change within both organizations, and we are developing an exciting vision for a future together that draws on what is best about each company. In the future, Genzyme will remain a vibrant organization, meeting the need for innovative treatments that change the lives of patients with serious diseases."
During the subsequent offering period, sanofi-aventis will accept for exchange, and promptly exchange, validly tendered shares of Genzyme common stock. Genzyme shareholders who validly tender their shares during the subsequent offering period will receive the same $74.00 in cash, without interest and less any required withholding taxes, and one contingent value right per share that was payable to shareholders who tendered their shares during the initial offering period. Procedures for tendering shares during the subsequent offering period are the same as during the initial offering period with two exceptions: Shares cannot be delivered by the guaranteed delivery procedure and pursuant to Rule 14d-7(a)(2) under the Securities Exchange Act of 1934, as amended, shares validly tendered during the subsequent offering period will be accepted for exchange on a daily, "as tendered" basis and, accordingly, may not be withdrawn.
After the subsequent offering period, sanofi-aventis intends to effect a short-form merger as permitted by Massachusetts law after exercising its top-up option under the merger agreement, if necessary. Genzyme will become a wholly-owned subsidiary of sanofi-aventis upon closing of the merger. As a result of the merger, any shares of Genzyme common stock not tendered in the exchange offer or during the subsequent offering period will be cancelled and (except for shares held by sanofi-aventis, Genzyme and their subsidiaries) converted into the right to receive the same $74.00 per share in cash and one contingent value right, per share, paid in the exchange offer.
Forward Looking Statements
This press release contains forward-looking statements. Forward-looking statements are statements that are not historical facts. These statements include product development, product potential projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future events, operations, products and services, and statements regarding future performance. Forward-looking statements are generally identified by the words "expects," "anticipates," "believes," "intends," "estimates," "plans" and similar expressions. Although sanofi-aventis' management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of sanofi-aventis, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMEA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such products candidates, the absence of guarantee that the products candidates if approved will be commercially successful, the future approval and commercial success of therapeutic alternatives, the Group's ability to benefit from external growth opportunities as well as those discussed or identified in the public filings with the SEC and the AMF made by sanofi-aventis, including those listed under "Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in sanofi-aventis' annual report on Form 20-F for the year ended December 31, 2010. Other than as required by applicable law, sanofi-aventis does not undertake any obligation to update or revise any forward-looking information or statements.
Important Additional Information
This communication is neither an offer to purchase nor a solicitation of any offer to sell any securities, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offering of securities shall be made except by means of a prospectus meeting the requirements of the U.S. Securities Act of 1933, as amended, or an exemption therefrom. In connection with the proposed transaction, sanofi-aventis has filed an amended tender offer statement and a registration statement on Form F-4 to register certain securities and certain related documents and Genzyme has filed a Solicitation/Recommendation Statement with respect to the exchange offer with the U.S. Securities and Exchange Commission (the "SEC"). Genzyme shareholders are urged to read the registration statement and exchange offer documents because they contain important information that shareholders should consider before making any decision regarding tendering their shares. These documents have been mailed to all Genzyme shareholders of record. These documents, as they may be amended from time to time, contain important information about the proposed transaction and Genzyme shareholders are urged to read them carefully and in their entirety before any decision is made with respect to the proposed transaction. Documentation relating to the transaction may be obtained at no charge at the website maintained by the SEC at www.sec.gov and may also be obtained at no charge by directing a request by mail to MacKenzie Partners, Inc., 105 Madison Avenue, New York, New York 10016, or by calling toll-free at (800) 322-2885. Free copies of the Solicitation/Recommendation Statement will be made available by Genzyme by directing a request to Genzyme at 500 Kendall Street, Cambridge, MA 02142, Attention: Shareholder Relations Department, or by calling 617-252-7500 and asking for the Shareholder Relations Department.
About sanofi-aventis
Sanofi-aventis, a leading global pharmaceutical company, discovers, develops and distributes therapeutic solutions to improve the lives of everyone. Sanofi-aventis is listed in Paris (EURONEXT : SAN) and in New York (NYSE : SNY). For more information, visit: www.sanofi-aventis.us or www.sanofi-aventis.com.
SOURCE sanofi-aventis
http://ih.advfn.com/p.php?pid=nmona&article=47141514
SAE
14 years ago
Genzyme Recognizes International Rare Disease Day by Launching New Patient Advocacy Grant Program
Genzyme Corporation (NASDAQ: GENZ) today recognized International Rare Disease Day with the launch of a new program, the Genzyme Patient Advocacy Leadership Awards (PAL Awards). A global grant program, the Genzyme PAL Awards will support non-profit organizations that work on behalf of patients living with lysosomal storage disorders (LSDs), a group of rare, inherited disorders that cause progressive and debilitating health problems. A total of $50,000 will be awarded through a competitive application process to organizations that seek funding for new initiatives that support the LSD patient community.
“For 30 years, Genzyme has been supporting patients through pioneering new treatments, free drug programs and through ongoing partnerships with patient organizations that serve the LSD patient community,” said Genzyme’s Director of Patient Advocacy, Jamie Manganello. “International Rare Disease Day is a great moment to launch the PAL Awards to commemorate the progress that has been made in partnership with the patient community, and as a reminder of our commitment to the work that is still ahead for us on behalf of patients and families affected by rare diseases.”
Organizations may apply for a Genzyme PAL Award for programs that support disease awareness, advocacy on behalf of patient communities, patient education and patient care, support and communication networks. This grant program is supplemental to Genzyme’s existing grants program and will not replace the contributions made locally each year to support advocacy groups. Proposals will be reviewed by an external review committee. Applications must be received by June 15, 2011, and the award recipients will be announced by July 31, 2011. For more information on the Genzyme PAL Awards program, or to apply for a grant, please visit www.genzymeadvocacyawards.com.
February 28, 2011 marks the fourth International Rare Disease Day, created by the patient organization EURORDIS and involving rare disease organizations globally. Genzyme is proud to have been a partner each year for International Rare Disease Day, and has organized events at Genzyme locations around this year’s theme, “Rare but Equal.” These events include presentations by patients with rare diseases at Genzyme offices, participation in a public event at the Massachusetts State House and today’s launch of the Genzyme PAL Awards.
About Genzyme
One of the world's leading biotechnology companies, Genzyme is dedicated to making a major positive impact on the lives of people with serious diseases. Since 1981, the company has grown from a small start-up to a diversified enterprise with approximately 10,000 employees in locations spanning the globe. Genzyme this month announced an agreement to be acquired by sanofi-aventis, and the transaction is expected to close early in the second quarter of this year.
With many established products and services helping patients in 100 countries, Genzyme is a leader in the effort to develop and apply the most advanced technologies in the life sciences. The company's products and services are focused on rare inherited disorders, kidney disease, orthopaedics, cancer, transplant, and immune disease. Genzyme's commitment to innovation continues today with a substantial development program focused on these fields, as well as cardiovascular disease, neurodegenerative diseases, and other areas of unmet medical need.
Genzyme’s press releases and other company information are available at www.genzyme.com and by calling Genzyme’s investor information line at 1-800-905-4369 within the United States or 1-678-999-4572 outside the United States.
Important Information
Genzyme has filed with the Securities and Exchange Commission a Solicitation/Recommendation Statement on Schedule 14D-9 relating to the tender offer by Sanofi-Aventis. Genzyme shareholders are advised to read the company's Solicitation/Recommendation Statement on Schedule 14D-9 because it contains important information. Shareholders may obtain a free copy of the Solicitation/Recommendation Statement on Schedule 14D-9, as well as any other documents filed by Genzyme in connection with the tender offer, free of charge at the SEC's website at http://www.sec.gov. In addition, investors can obtain free copies of these documents from Genzyme by directing a request to Genzyme at 500 Kendall Street, Cambridge, MA 02142, Attention: Shareholder Relations Department, or by calling 617-252-7500 and asking for the Shareholder Relations Department.
http://ih.advfn.com/p.php?pid=nmona&article=46650486
SAE
14 years ago
CORRECT: Sanofi Needs To Avoid Pitfalls Of Past Pharma-Biotech Deals
Sanofi-Aventis SA's (SNY) long courtship of Genzyme Corp. (GENZ) has finally ended in an acquisition deal, but now comes the hard part: making the marriage work.
The track record of large pharmaceutical companies purchasing smaller biotechnology and specialty-drug makers is mixed. Buyers tend to overvalue the acquired assets, and the talent that made the acquiree attractive frequently depart to a new project.
Roche Holding AG (RHHBY) said it had tried to avoid those pitfalls following its acquisition of full control of biotech company Genentech in 2009 for $46.8 billion, but then it got hit by another risk from these deals--unforeseen challenges.
In Sanofi's case, the company has taken some steps to mitigate the risks in its planned purchase of Genzyme for at least $20.1 billion, unveiled earlier Wednesday. In addition to the cash consideration, Genzyme shareholders will receive rights eligible for future cash payments if Genzyme hits certain milestones, an arrangement that addresses some of the speculative risk inherent in drug development.
What's more, Genzyme is no baby biotech. It's a more mature company that has had profitable drugs on the market for years. So the company isn't making a big bet on unproven research-and-development, as much as expanding its drug-making operations.
"Biotechnology had never really been embraced by Sanofi-Aventis in the past, and I think that proved to be a weakness of the company," Sanofi Chief Executive Christopher Viehbacher said Wednesday.
But there are always risks in such combinations that Viehbacher will have to carefully navigate. Aside from the potential for drug setbacks, the slow-moving hierarchies at big drug makers can chase off talented executives and scientists at the smaller companies they snatch up, undercutting the future potential of the acquired assets.
"There's a tendency to overpay," said Morningstar analyst Damien Conover. "The innovative spirit of the entrepreneurial nature of biotech, that tends to be the hardest thing you can keep."
Roche Chief Executive Severin Schwan said in a recent interview that Roche has for the most part tried to leave Genentech's R&D labs alone.
"Innovation and science need a decentralized management approach," he said. "In research and development, it is not a matter of scale. I would rather have a bit of duplication at the centers in the world, than lose productivity."
Roche did streamline administrative, financial and back-office functions immediately--including scaling back an operation in Nutley, N.J.--but Schwan said the company has been successful in retaining scientists and researchers because the culture hasn't changed. He said he believes that many companies approach integrations by using accountants and spreadsheets to squeeze out savings, something that forces an internal focus and distraction among workers.
"If you think that you have to align everything around the globe, that everybody has to do it along one recipe, then you kill innovation. That is the beginning of the end," he said.
However, the Roche-Genentech deal also illustrates the risk that acquired products can encounter, namely challenges that may not have been fully apparent at the time of the transaction. Sales growth for Roche's Avastin cancer drug, which was developed by Genentech, are now seen slowing partly because of U.S. regulatory scrutiny of its effectiveness.
"I think the big concern with integrating any deal like this is the larger company not absorbing the culture of the smaller companies," said Christopher Bowe, a health-care analyst with research and publishing firm Informa.
"There's a tendency for the acquiring company to come in with an attitude that it probably knows best," Bowe said. Big companies need to be more open to adapting the best practices of the acquired company, especially in making research labs more productive, he said.
When deals between large pharmaceuticals and smaller biotechs pay off, the upside is often so big that it offsets the failed deals. As a result, big drug makers--especially those facing patent-expiration challenges like Sanofi--are often willing to continue to shell out big bucks.
Johnson & Johnson's (JNJ) $5 billion purchase of Centocor in 1999 succeeded because Centocor's Remicade anti-inflammatory drug went on to become a blockbuster and J&J inherited talented personnel. But the jury is still out on whether AstraZeneca PLC's (AZN) 2007 purchase of MedImmune was worth its $14 billion price tag, as the acquired products haven't provided a big lift to overall financial performance.
AstraZeneca, in an emailed statement, called the MedImmune buy "a long-term strategic investment" and noted that the "product development timeline in our industry is long and relatively unpredictable." The company touted MedImmune's research expertise in biotechnology-style drugs.
Eli Lilly & Co. (LLY) bought ImClone Systems in 2008 for $6.5 billion on hopes for continued sales growth for cancer drug Erbitux, as well as the expectation that one or more of ImClone's experimental drugs would reach the market and have commercial success.
But Erbitux sales have slowed after the discovery that it wasn't effective in people with a certain genetic profile, and Lilly and partner Bristol-Myers Squibb Co. (BMY) recently halted a late-stage trial of experimental cancer drug necitumumab because of safety concerns. Another late-stage trial for the drug continues.
-Peter Loftus, Dow Jones Newswires; +1-215-656-8289; peter.loftus@dowjones.com
--Thomas Gryta contributed to this article.
http://ih.advfn.com/p.php?pid=nmona&article=46517004
SAE
14 years ago
Three-Year Data from Phase 2 Trial of Genzyme Gaucher Disease Oral Compound Suggest Sustained or Further Improvement Across A...
Genzyme Corporation (NASDAQ: GENZ) today announced three-year follow-up data from patients enrolled in the phase 2 clinical trial for its investigational oral therapy for Gaucher disease type 1 known as eliglustat tartrate. Sustained or further improvements were observed across all endpoints, including bone disease, at the three-year timepoint. The results were presented for the first time this week at the Lysosomal Disease Network WORLD Symposium in Las Vegas, Nevada.
Genzyme previously reported that the eliglustat tartrate phase 2 trial had met its primary endpoint at one year, and that data demonstrated continued improvement through two years. The primary composite endpoint was a clinically meaningful response in at least two of three endpoints: improvements in spleen size, hemoglobin and platelet levels. The study has continued with 19 patients through three years. The extension phase of this trial is still ongoing.
Eliglustat tartrate continued to show robust clinical response through three years:
Spleen volume decreased from baseline by a mean of 61 percent and liver volume decreased from baseline by 29 percent.
Hemoglobin level increased from baseline by a mean of 2.6 grams per deciliter.
Platelet count increased from baseline by a mean of 91 percent.
The study also analyzed the clinical response of patients in the phase 2 trial with respect to achieving therapeutic goals. Due to the heterogeneity of Gaucher disease, therapeutic goals were previously developed by experts involved in the treatment of Gaucher patients to assess their response to enzyme replacement therapy (ERT). Most patients dosed with eliglustat tartrate met established therapeutic goals for hemoglobin, platelets, spleen volume and liver volume, demonstrating progressive and clinically meaningful responses in multiple organ systems. At three years, 100 percent of patients met at least 3 of the 4 therapeutic goals developed for hematologic and organ volume parameters.
The three-year data also included analyses that suggest eliglustat tartrate positively impacts indicators of bone disease through three years of follow up. These indicators include bone mineral density in the lumbar spine, as measured by dual energy x-ray absorptiometry (DXA), and dark marrow signal in the femur, as visualized by magnetic resonance imaging (MRI). Dark marrow reflects the infiltration of lipid-laden Gaucher cells into bone marrow. Specifically:
In the 18 patients at baseline with dark marrow in the femur visible by MRI, five improved by one year, seven by two years and 10 by three years, with the other eight patients remaining stable.
In the 15 patients with results available at all time points, bone mineral density in the lumbar spine showed clinically and statistically significant improvements after one year of treatment (T score = +0.4) which further improved after 2 years (T score = +0.6) and were sustained after three years of treatment.
Ravi S. Kamath, M.D., Ph.D., Staff Radiologist at Massachusetts General Hospital and Instructor in Radiology at Harvard Medical School, who is the central radiology reviewer for the phase 2 study, said, "These data suggest that eliglustat tartrate may have a meaningful clinical impact on bone disease in Gaucher disease type 1 patients."
The most common adverse events (AEs) reported in greater than 2 patients through three years included viral infections (six patients), urinary tract infections and upper respiratory infections (4 patients each), headache, increased blood pressure, diarrhea and abdominal pain (three patients each). Eight drug-related AEs, including one serious event, were reported in six patients. Most AEs overall and all drug-related AEs were considered mild. The largest number of AEs was reported during the first 3 months of treatment.
“For thirty years, Genzyme has pioneered treatments for patients with lysosomal storage disorders, including the very first enzyme replacement therapy for Gaucher disease,” said Genzyme’s President, Personalized Genetic Health, John P. Butler. “Our momentum continues through the phase 3 trials – the largest ever conducted for Gaucher - as we build upon our foundation and commitment to Gaucher and look to extend the therapeutic options available to patients and physicians.”
Eliglustat tartrate, a capsule taken orally, is being developed to provide a convenient treatment alternative for adult patients with Gaucher disease type 1, and to offer a broader range of treatment options for patients and physicians to achieve individual therapeutic goals. Genzyme is currently enrolling patients in three global, multi-center, phase 3 trials of eliglustat tartrate. This is the largest clinical program ever focused on Gaucher disease, with over 50 sites in more than 25 countries currently participating. Genzyme’s Gaucher disease portfolio also offers Cerezyme® (imiglucerase for injection), the standard of care for patients with Gaucher disease type 1, which is administered through intravenous infusions.
To learn more about the phase 3 trials of eliglustat tartrate, contact Genzyme Medical Information at medinfo@genzyme.com or 1-800-745-4447. More information can also be found at www.clinicaltrials.gov or www.explorerstudies.com.
About Gaucher disease
Gaucher disease is an inherited condition affecting fewer than 10,000 people worldwide. People with Gaucher disease do not have enough of an enzyme, acid ß-glucosidase (glucocerebrosidase) that breaks down a certain type of fat molecule. As a result, lipid engorged cells (called Gaucher cells) amass in different parts of the body, primarily the spleen, liver and bone marrow. Accumulation of Gaucher cells may cause spleen and liver enlargement, anemia, excessive bleeding and bruising, bone disease and a number of other signs and symptoms. The most common form of Gaucher disease, type 1, does not typically affect the nervous system and brain.
About eliglustat tartrate
Eliglustat tartrate, a novel glucosylceramide analog given orally, is designed to partially inhibit the enzyme glucosylceramide synthase, which results in reduced production of glucosylceramide. Glucosylceramide is the substance that builds up in the cells and tissues of people with Gaucher disease. In preclinical studies, the molecule, developed with James A. Shayman, M.D. from the University of Michigan, has shown high potency and specificity. Based on its mechanism of action, which is independent of genotype, eliglustat tartrate may be a potential therapy for patients with Gaucher disease type 1. Initiation of the phase 2 and 3 studies of eliglustat tartrate in Gaucher disease followed completion of an extensive pre-clinical research effort and a phase 1 program. Over 300 subjects have now been treated in nine separate studies.
The data from the phase 2 trials with eliglustat tartrate were previously published in the journal Blood and the results can be found at the below references:
Phase 2 data at the 1 year time point: Lukina et al. Blood, Aug 2010; Vol. 116: 893 - 899
Phase 2 data at the 2 year time point: Lukina et al. Blood, Nov 2010; Vol 116: 4095 - 4098
Cerezyme important safety information
Approximately 15 percent of patients have developed IgG antibodies, and these patients have a higher risk of hypersensitivity reaction. Therefore periodic monitoring is suggested; caution should be exercised in patients with antibodies or prior symptoms of hypersensitivity. Symptoms suggestive of hypersensitivity occurred in 6.6 percent of patients, and include anaphylactoid reaction, pruritus, flushing, urticaria, angioedema, chest discomfort, dyspnea, coughing, cyanosis and hypotension. Reactions related to Cerezyme administration have been reported in less than 15 percent of patients. Each of the following events occurred in less than 2 percent of the total patient population. Reported adverse events include nausea, vomiting, abdominal pain, diarrhea, rash, fatigue, headache, fever, dizziness, chills, backache, and tachycardia. Adverse events associated with the route of administration include discomfort, pruritus, burning, swelling or sterile abscess at the site of venipuncture. For full prescribing information, please visit www.genzyme.com.
About Genzyme
One of the world's leading biotechnology companies, Genzyme is dedicated to making a major positive impact on the lives of people with serious diseases. Since 1981, the company has grown from a small start-up to a diversified enterprise with approximately 10,000 employees in locations spanning the globe.
With many established products and services helping patients in 100 countries, Genzyme is a leader in the effort to develop and apply the most advanced technologies in the life sciences. The company's products and services are focused on rare inherited disorders, kidney disease, orthopaedics, cancer, transplant, and immune disease. Genzyme's commitment to innovation continues today with a substantial development program focused on these fields, as well as cardiovascular disease, neurodegenerative diseases, and other areas of unmet medical need. Genzyme’s press releases and other company information are available at www.genzyme.com and by calling Genzyme’s investor information line at 1-800-905-4369 within the United States or 1-678-999-4572 outside the United States.
Important Information
Genzyme has filed with the Securities and Exchange Commission a Solicitation/Recommendation Statement on Schedule 14D-9 relating to the tender offer by Sanofi-Aventis. Genzyme shareholders are advised to read the company's Solicitation/Recommendation Statement on Schedule 14D-9 because it contains important information. Shareholders may obtain a free copy of the Solicitation/Recommendation Statement on Schedule 14D-9, as well as any other documents filed by Genzyme in connection with the tender offer, free of charge at the SEC's website at http://www.sec.gov. In addition, investors can obtain free copies of these documents from Genzyme by directing a request to Genzyme at 500 Kendall Street, Cambridge, MA 02142, Attention: Shareholder Relations Department, or by calling 617-252-7500 and asking for the Shareholder Relations Department.
Genzyme® and Cerezyme® are registered trademarks of Genzyme Corporation. All rights reserved.
http://ih.advfn.com/p.php?pid=nmona&article=46535474
SAE
14 years ago
Genzyme Will Allow Sanofi-Aventis to Conduct Due Diligence
Genzyme Corp. (NASDAQ: GENZ) announced today that ongoing discussions with Sanofi-Aventis have progressed to the point where Genzyme’s board has authorized the company to enter into a confidentiality agreement with Sanofi-Aventis in order to allow Sanofi to conduct due diligence. Discussions between Genzyme’s advisors and Sanofi’s advisors and between Genzyme and Sanofi representatives are continuing. These discussions have focused to a significant degree on the potential use of a contingent value right for alemtuzumab as a part of a potential resolution of the differences in valuation between the parties, and the parties have also discussed other potential terms for a negotiated transaction.
Genzyme can provide no assurance that discussions with Sanofi will result in a transaction that will be determined by its board to be in the best interests of the company and its shareholders.
About Genzyme
One of the world's leading biotechnology companies, Genzyme is dedicated to making a major positive impact on the lives of people with serious diseases. Since 1981, the company has grown from a small start-up to a diversified enterprise with approximately 10,000 employees in locations spanning the globe.
With many established products and services helping patients in 100 countries, Genzyme is a leader in the effort to develop and apply the most advanced technologies in the life sciences. The company's products and services are focused on rare inherited disorders, kidney disease, orthopaedics, cancer, transplant, and immune disease. Genzyme's commitment to innovation continues today with a substantial development program focused on these fields, as well as cardiovascular disease, neurodegenerative diseases, and other areas of unmet medical need.
Important Information
Genzyme has filed with the Securities and Exchange Commission a Solicitation/Recommendation Statement on Schedule 14D-9 relating to the tender offer by Sanofi-Aventis. Genzyme shareholders are advised to read the company's Solicitation/Recommendation Statement on Schedule 14D-9 because it contains important information. Shareholders may obtain a free copy of the Solicitation/Recommendation Statement on Schedule 14D-9, as well as any other documents filed by Genzyme in connection with the tender offer, free of charge at the SEC's website at http://www.sec.gov. In addition, investors can obtain free copies of these documents from Genzyme by directing a request to Genzyme at 500 Kendall Street, Cambridge, MA 02142, Attention: Shareholder Relations Department, or by calling 617-252-7500 and asking for the Shareholder Relations Department.
Genzyme’s press releases and other company information are available at www.genzyme.com and by calling Genzyme’s investor information line at 1-800-905-4369 within the United States or 1-678-999-4572 outside the United States.
http://ih.advfn.com/p.php?pid=nmona&article=46232003
SAE
14 years ago
Genzyme to Build Additional Plant to Support Growth of Myozyme® and Lumizyme®
Genzyme Corp. (NASDAQ: GENZ) today announced that it will build an additional manufacturing plant in Geel, Belgium, to support the long-term growth of Myozyme® and Lumizyme® for Pompe disease. The company held a ceremony today in Geel to mark the start of construction of the new €250 million plant, which will include 8,000 liters of production capacity, a complete purification installation, and ample room for additional future capacity expansions. Commercial approvals for the new site are expected to start late 2014.
Genzyme currently produces Myozyme and Lumizyme at an adjacent plant in Geel, where it is increasing production capacity to 12,000 liters with the addition of a third bioreactor scheduled for approval by the end of this year. Genzyme is also continuing its 160 L production in the U.S. for patients with infantile-onset Pompe disease. The investment in Geel is part the company’s program to increase its overall biologics manufacturing capacity four fold. About 150 new jobs will be created as part of the expansion, bringing the total workforce at the site to nearly 600 people.
“The expansion of our Geel facility is a critical element of our manufacturing strategy and is fundamental to our mission,” said Scott Canute, Genzyme’s President, Global Manufacturing and Corporate Operations. “We are committed to delivering a reliable supply of high quality medicines to our patients. This investment ensures continued supply to our patients in the Pompe community for the long term.”
Genzyme believes that its Pompe disease treatments represent a commercial opportunity that is comparable to that of Cerezyme for Gaucher disease. The company estimates that there are about 10,000 Pompe patients worldwide; approximately 1,400 Pompe patients are currently treated with either Myozyme or Lumizyme, which are the only treatments approved for the disease. Myozyme is currently available in 48 markets worldwide and Genzyme expects to increase this to 60 markets by the end of this year.
"Our strong track record of results, the expertise and dedication of our workforce along with the partnership with the authorities in Belgium, have been instrumental in bringing this exciting new investment to our site," said Piet Houwen, General Manager of Genzyme’s Geel manufacturing site.
About Pompe Disease
Pompe disease is a progressive, debilitating and often fatal neuromuscular disease caused by a genetic deficiency or dysfunction of the lysosomal enzyme acid alpha-glucosidase (GAA). This enzymatic defect results in the accumulation of glycogen primarily in muscle tissues that leads to muscle weakness, loss of respiratory function, and often premature death. When symptoms occur in infancy, babies typically die within the first year of life. When symptoms occur in childhood or adulthood, patients typically lose their ability to walk and require wheelchairs to assist with mobility and experience difficulty breathing as well as mechanical ventilation to breathe.
About Myozyme and Lumizyme
Alglucosidase alfa, known as Lumizyme in the US and as Myozyme in the rest of the world, targets the underlying cause of Pompe disease by replacing the enzyme that is deficient. In the US, Lumizyme is indicated for patients 8 years and older with late (non-infantile) onset Pompe disease (GAA deficiency) who do not have evidence of cardiac hypertrophy. In the US, Myozyme (alglucosidase alfa) is indicated for use in patients with Pompe disease (GAA deficiency). Myozyme has been shown to improve ventilator-free survival in patients with infantile-onset Pompe disease as compared to an untreated historical control, whereas use of Myozyme in patients with other forms of Pompe disease has not been adequately studied to assure safety and efficacy. In Europe, Myozyme is indicated for infants, children and adults with Pompe disease.
About Genzyme
One of the world's leading biotechnology companies, Genzyme is dedicated to making a major positive impact on the lives of people with serious diseases. Since 1981, the company has grown from a small start-up to a diversified enterprise with approximately 10,000 employees in locations spanning the globe.
With many established products and services helping patients in approximately 100 countries, Genzyme is a leader in the effort to develop and apply the most advanced technologies in the life sciences. The company's products and services are focused on rare inherited disorders, kidney disease, orthopaedics, cancer, transplant and immune disease. Genzyme's commitment to innovation continues today with a substantial development program focused on these fields, as well as cardiovascular disease, neurodegenerative diseases, and other areas of unmet medical need.
This press release contains forward-looking statements regarding Genzyme’s business plans including, without limitation, statements about the expansion of manufacturing capacity for Myozyme and Lumizyme in Geel, Belgium, the timing of regulatory approvals and expectations relating to the production of Lumizyme and Myozyme. These statements are subject to risks and uncertainties that could cause actual results to differ materially from those forecasted. These risks and uncertainties include, among others: whether Genzyme has forecasted the size of the commercial opportunity and potential product demand accurately; whether Genzyme is able to manufacture product in sufficient quantities to meet demand; whether the FDA and other regulatory authorities approve the manufacturing facilities in Geel and the timing thereof; whether regulatory approval for Myozyme is received from regulatory authorities in the expected timeframe; whether the new facility allows for additional expansion as expected; and the risks and uncertainties described in Genzyme's SEC reports filed under the Securities Exchange Act of 1934, including the factors discussed under the caption "Risk Factors" in Genzyme's Quarterly Report on Form 10-Q for the quarter ended September 30, 2010. Genzyme cautions investors not to place substantial reliance on the forward-looking statements contained in this press release. These statements speak only as of the date of this press release and Genzyme undertakes no obligation to update or revise these statements.
Genzyme® and Myozyme® are registered trademarks, and Lumizyme™ is a trademark, of Genzyme Corporation or its subsidiaries. All rights reserved.
Important Information
Genzyme has filed with the Securities and Exchange Commission a Solicitation/Recommendation Statement on Schedule 14D-9 relating to the tender offer by Sanofi-Aventis. Genzyme shareholders are advised to read the company's Solicitation/Recommendation Statement on Schedule 14D-9 because it contains important information. Shareholders may obtain a free copy of the Solicitation/Recommendation Statement on Schedule 14D-9, as well as any other documents filed by Genzyme in connection with the tender offer, free of charge at the SEC's website at http://www.sec.gov. In addition, investors can obtain free copies of these documents from Genzyme by directing a request to Genzyme at 500 Kendall Street, Cambridge, MA 02142, Attention: Shareholder Relations Department, or by calling 617-252-7500 and asking for the Shareholder Relations Department.
http://ih.advfn.com/p.php?pid=nmona&article=46099082
MinnieM
14 years ago
Sanofi Sees `Significant Differences' in Genzyme Talks
http://www.bloomberg.com/news/2011-01-09/sanofi-says-significant-differences-on-terms-for-potential-cvr.html
Sanofi-Aventis SA said “significant differences” remain in takeover talks with Genzyme Corp., and there’s no guarantee a deal will be reached.
Bankers have been discussing extra payments tied to the performance of Lemtrada, an experimental treatment for multiple sclerosis, and executives from the two companies are now involved in the talks, Sanofi said in an e-mailed statement yesterday. Sanofi on Oct. 4 made a hostile offer of $69 a share, or $18.5 billion, for Genzyme, which Genzyme rejected as too low.
Genzyme’s Lemtrada, sold under the name Campath as a treatment for blood cancer, may have sales of $3 billion to $3.5 billion by 2017 if approved for multiple sclerosis, according to the Cambridge, Massachusetts-based company. Paris-based Sanofi and Genzyme are discussing a “contingent value right,” under which Sanofi would make additional payments for regulatory approval of the drug and the achievement of certain sales thresholds, according to the Sanofi statement.
“There remain significant differences on the terms and conditions of the potential CVR and the value of our offer, and there is no guarantee that the parties will come to an agreement,” Sanofi said.
The two sides are making progress in takeover talks, and the French drugmaker is weighing a symbolic increase to its offer, two people with knowledge of the situation said Jan. 7. Sanofi is open to raising its offer by about $2 to get access to Genzyme’s books once the two sides agree on the extra payments, said the people, who declined to be identified because the talks are private.
Specific Milestones
Those payments may be worth $5 to $6 a share, said one of the people. The exact value, along with specific milestones tied to sales and profits, are still being negotiated, the person said.
Sanofi and Genzyme will not begin specific discussions about price until the CVR issue is settled, the person said. For Sanofi to begin due diligence, it would have to disclose publicly a confidentiality agreement, the person said.
Genzyme is in the final stages of testing Lemtrada against MS and expects data from those trials this year.
Sanofi, France’s biggest drugmaker, took its offer for Genzyme directly to shareholders on Oct. 4, after Chief Executive Officer Henri Termeer spurned the bid as too low and refused to negotiate. The offer, made public Aug. 29, undervalued Genzyme’s stable of experimental drugs and ignores expected revenue growth after the company fixed manufacturing flaws that caused drug shortages, Termeer said.
Additional Payments
The companies are discussing an agreement that would potentially value Genzyme at about $80 a share, the Wall Street Journal reported Jan. 7. That price would include the additional payments, the newspaper said.
Genzyme shares have traded above $69 since the offer was made public in August. The shares rose 4.1 percent to $74.35 in after-hours trading in New York Jan. 7 following the WSJ report.
Sanofi is seeking acquisitions to replace revenue the company is losing as some of its biggest-selling products, such as the blood thinner Plavix and the cancer drug Taxotere, face competition from generic medicines.
Genzyme, the world’s largest maker of drugs for rare genetic diseases, has products that are less likely to face generic competitors because they’re made from living cells and are harder to copy than pills made from chemicals. The U.S. Food and Drug Administration designated the therapies as orphan drugs because they’re for diseases without other treatment options, giving them more patent protection.
To contact the reporter on this story: Phil Serafino in Paris at pserafino@bloomberg.net; Jeffrey McCracken in New York at jmccracken3@bloomberg.net; Jacqueline Simmons in Paris at jackiem@bloomberg.net
To contact the editor responsible for this story: Jennifer Sondag at jsondag@bloomberg.net;
SAE
14 years ago
Genzyme Details Market Potential of Alemtuzumab for MS
Genzyme Corporation (NASDAQ: GENZ) today provided an extensive briefing on the market potential of alemtuzumab for multiple sclerosis at an event for investors and analysts in New York. During the two-hour presentation, the company shared internal market research and independent, third-party analysis defining the unmet needs today in MS, key features of the alemtuzumab profile that may address these needs and physician and payer perspectives on the future positioning and uptake of alemtuzumab in the MS market. This research supports forecasts for alemtuzumab adoption and anticipated peak sales of $3-3.5 billion.
The event was part of a program, initiated in October by Genzyme’s board and management, to communicate with shareholders regarding the company’s value.
Market Research
Genzyme has conducted extensive market research related to the market potential for alemtuzumab in MS, including interviews with more than 2,500 prescribers and payers in major markets. This work confirms that there is significant demand for new therapeutic options with improved efficacy, tolerability and convenience over existing therapies and that alemtuzumab has the potential to address many of these unmet needs.
“There is still a significant unmet need in multiple sclerosis and we desire new treatments,” said Edward Fox, M.D., Ph.D., Director of the Multiple Sclerosis Clinic of Central Texas, one of the largest multiple sclerosis treatment centers in the U.S. “Currently our goal is to slow disability progression and reduce relapses. However, alemtuzumab has the potential to improve function as well as to halt the accumulation of disability and relapses, setting a new bar for MS treatment efficacy.”
Genzyme’s market research found that many respondents view alemtuzumab as a potentially paradigm-shifting therapeutic option that may specifically address limitations of current care, based on the profile emerging from the phase 2 study.
Key findings from conjoint analyses, a statistical approach that assigns value to product features against those of competing products, show that:
U.S. and European physicians strongly associate alemtuzumab with best-in-class efficacy against other disease modifying therapies, including natalizumab and emerging oral options cladribine and fingolimod;
The most important attribute driving therapy choice in treatment-experienced patients, who comprise the majority of the MS market today, is efficacy;
With the convenience and compliance advantage of annual dosing, a significant percentage of physicians rate alemtuzumab’s administration schedule as outstanding;
Based upon alemtuzumab’s profile, physicians assign a higher preference share for alemtuzumab in treatment-experienced patients (43 percent) than treatment-naïve patients (11 percent), supporting the view that therapy switching by patients is anticipated to be a strong growth driver; and
Physicians score alemtuzumab significantly higher than natalizumab on measures of safety and efficacy.
To evaluate these findings further, Genzyme’s board commissioned an independent market analysis completed in October 2010. This research was based on existing phase 2 data and assumed the approval of alemtuzumab and emerging oral therapies fingolimod and cladribine. The analysis included interviews with over 100 neurologists and payers, and surveys from more than 200 physicians across four major markets—the U.S., France, Germany and the United Kingdom. Key findings from this work include the following:
Efficacy was the primary prescribing decision in all major markets;
Alemtuzumab would be adopted across all lines of use;
Second- and third-line alemtuzumab use is anticipated and held the greatest share in large markets;
Physician adoption of alemtuzumab would approach 5 percent in the first year after launch; 10-12 percent two to three years after launch; and 18-20 percent five or more years after launch.
Revenue Projections
The consistent findings from this and other research supports market penetration launch assumptions and revenue growth models. The company expects rapid adoption and peak sales of roughly $3-3.5 billion within 5 years of launch.
The company’s projected adoption rates for alemtuzumab compare well against actual historical adoption rates for other innovative therapies:
Early phase adoption rate projections for alemtuzumab are proportionate to the 2007-2009 adoption rates for MS therapy natalizumab (in its second launch following a post-marketing safety signal);
Peak market share projections for alemtuzumab are more conservative than the actual market share levels achieved by current MS therapies, as well as therapies with superior efficacy introduced in other disease areas, such as rheumatoid arthritis.
Alemtuzumab MS Care Innovations and Pharmacoeconomic Impact
Five-year follow-up data from the company’s completed phase 2 trial, a large randomized trial against an active MS comparator, found that alemtuzumab-treated patients had significant reductions in relapses and disability. For many alemtuzumab-treated patients, these benefits were sustained several years after receiving their last course of treatment. Over this period, the mean disability score for patients receiving alemtuzumab improved, but worsened for patients receiving the active comparator.
The precise mechanism of action of alemtuzumab in the treatment of MS is unknown and remains an area of active study. Emerging data suggest that the observed clinical effects of alemtuzumab in relapsing MS may be the result of immunomodulation following the repopulation of immune cells post-treatment. Specifically, research conducted by Genzyme in collaboration with investigators at the University of Cambridge suggests that:
Depletion of CD52+ autoreactive lymphocytes may induce re-setting of the immunological clock;
Enrichment of T cells with regulatory activity may result in a tolerogenic environment during repopulation; and
Increased lymphocyte production of neurotrophic factors occurs post-treatment.
Adding to these innovations is a new dosing model. Unlike daily, weekly, or monthly dosing of existing therapies, alemtuzumab follows an annual course approach. The once-yearly schedule offers substantial convenience and potential tolerability advantages for patients, while avoiding some compliance issues that can occur with more frequent dosing such as daily pills or injections required for some current therapies.
Based on the phase 2 data, the company’s pharmacoeconomic research shows a substantial positive impact on health system resources:
Reduction in the costs related to chronic treatment;
Potentially fewer hospitalizations and associated costs due to relapses; and
A potential decrease in expenses from disability care.
The company has held more than 100 payer and regulatory interviews across major markets, and alemtuzumab’s potential innovations for MS care are recognized. Most large markets, including the U.S., are likely to support value pricing if phase 3 data confirms earlier findings.
Phase 3 Program
Genzyme is conducting two pivotal phase 3 trials to evaluate alemtuzumab in the treatment of MS. CARE-MS I, a randomized trial comparing alemtuzumab to Rebif, is studying early, active relapsing-remitting MS patients who have received no prior therapy. CARE-MS II, which also compares alemtuzumab to Rebif, is studying relapsing-remitting MS patients who experience disease activity while on other MS therapies. Data from the phase 3 trials are expected beginning in mid-2011. The company expects to file for U.S. and E.U. approval in early 2012, and has been granted fast track status by the FDA for this program.
Alemtuzumab is an investigational drug for the treatment of MS and must not be used in MS patients outside of a formal, regulated clinical trial setting in which appropriate patient monitoring measures are in place.
About Genzyme
One of the world's leading biotechnology companies, Genzyme is dedicated to making a major positive impact on the lives of people with serious diseases. Since 1981, the company has grown from a small start-up to a diversified enterprise with approximately 10,000 employees in locations spanning the globe and 2009 revenues of $4.5 billion. In 2010, Genzyme was named to the Fortune 500.
With many established products and services helping patients in 100 countries, Genzyme is a leader in the effort to develop and apply the most advanced technologies in the life sciences. The company's products and services are focused on rare inherited disorders, kidney disease, orthopaedics, cancer, transplant, and immune disease. Genzyme's commitment to innovation continues today with a substantial development program focused on these fields, as well as cardiovascular disease, neurodegenerative diseases, and other areas of unmet medical need.
Important Information
Genzyme has filed with the Securities and Exchange Commission a Solicitation/Recommendation Statement on Schedule 14D-9 relating to the tender offer by Sanofi-Aventis. Genzyme shareholders are advised to read the company's Solicitation/Recommendation Statement on Schedule 14D-9 because it contains important information. Shareholders may obtain a free copy of the Solicitation/Recommendation Statement on Schedule 14D-9, as well as any other documents filed by Genzyme in connection with the tender offer, free of charge at the SEC's website at http://www.sec.gov. In addition, investors can obtain free copies of these documents from Genzyme by directing a request to Genzyme at 500 Kendall Street, Cambridge, MA 02142, Attention: Shareholder Relations Department, or by calling 617-252-7500 and asking for the Shareholder Relations Department.
Safe-Harbor
This press release contains forward-looking statements, including the statements regarding: expectations for peak sales of alemtuzumab and related timing expectations; forecasts for adoption of alemtuzumab by physicians and the marketplace; the ability of alemtuzumab to meet patient needs in the treatment of MS; the potential of alemtuzumab to halt accumulation of disability and relapses and improve function; the potential of alemtuzumab to be a paradigm-shifting treatment option for MS; the view that patients switching to alemtuzumab will be a strong driver of growth; the possible mechanism of action of alemtuzumab; the potential tolerability advantages of alemtuzumab; the positive impact of adoption on health care system resources; the likelihood of value pricing being supported in large markets, including the U.S.; and the expected timelines for results of the phase 3 clinical trials and filing for regulatory approvals. These statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected in these forward-looking statements. These risks and uncertainties include: the possibility that phase 3 trials will not support the same conclusions as the phase 2 trials; the risk that alemtuzumab will not receive regulatory approvals on the timeframes expected or at all; the risk that the results of the phase 3 clinical trials may be delayed; the possibility that peak sales of alemtuzumab will not achieve projected levels as a result of the inaccuracy of underlying assumptions or as a result of other risks and uncertainties not contemplated or adequately accounted for by Genzyme’s market research; the risks that alemtuzumab will not address the unmet needs of MS patients or that physicians and the marketplace will not adopt alemtuzumab to the extent expected; the risk that pricing will not be supported at projected levels; the risk we will not be able to implement our business plans for alemtuzumab successfully or as expected; and the risks and uncertainties described in Genzyme's SEC reports filed under the Securities Exchange Act of 1934, including the factors discussed under the caption "Risk Factors" in Genzyme's Quarterly Report on Form 10-Q for the period ended September 30, 2010. We caution investors not to place undue reliance on the forward-looking statements contained in this press release. These statements speak only as of the date of this press release, and we undertake no obligation to update or revise these statements.
Genzyme’s press releases and other company information are available at www.genzyme.com and by calling Genzyme’s investor information line at 1-800-905-4369 within the United States or 1-678-999-4572 outside the United States.
http://ih.advfn.com/p.php?pid=nmona&article=45729461
SAE
14 years ago
Genzyme to Hold Investor Event on Alemtuzumab
Genzyme Corp. (NASDAQ: GENZ) announced today that it will hold an Analyst and Investor meeting in New York on December 20, 2010, focused specifically on the commercial potential of alemtuzumab for multiple sclerosis. The event will be webcast live from 1:00 p.m.-3:00 p.m. Eastern on the investor events section of www.genzyme.com. The event is part of Genzyme’s ongoing program to communicate with shareholders regarding the intrinsic value of the company.
About Genzyme
One of the world's leading biotechnology companies, Genzyme is dedicated to making a major positive impact on the lives of people with serious diseases. Since 1981, the company has grown from a small start-up to a diversified enterprise with approximately 10,000 employees in locations spanning the globe and 2009 revenues of $4.5 billion. In 2010, Genzyme was named to the Fortune 500.
With many established products and services helping patients in 100 countries, Genzyme is a leader in the effort to develop and apply the most advanced technologies in the life sciences. The company's products and services are focused on rare inherited disorders, kidney disease, orthopaedics, cancer, transplant, and immune disease. Genzyme's commitment to innovation continues today with a substantial development program focused on these fields, as well as cardiovascular disease, neurodegenerative diseases, and other areas of unmet medical need.
Important Information
Genzyme has filed with the Securities and Exchange Commission a Solicitation/Recommendation Statement on Schedule 14D-9 relating to the tender offer by Sanofi-Aventis. Genzyme shareholders are advised to read the company's Solicitation/Recommendation Statement on Schedule 14D-9 because it contains important information. Shareholders may obtain a free copy of the Solicitation/Recommendation Statement on Schedule 14D-9, as well as any other documents filed by Genzyme in connection with the tender offer, free of charge at the SEC's website at http://www.sec.gov. In addition, investors can obtain free copies of these documents from Genzyme by directing a request to Genzyme at 500 Kendall Street, Cambridge, MA 02142, Attention: Shareholder Relations Department, or by calling 617-252-7500 and asking for the Shareholder Relations Department.
Genzyme’s press releases and other company information are available at www.genzyme.com and by calling Genzyme’s investor information line at 1-800-905-4369 within the United States or 1-678-999-4572 outside the United States.
SAE
14 years ago
Genzyme Completes Sale of Genetic Testing Business to LabCorp
Genzyme Corporation (Nasdaq: GENZ) today announced that it has completed the sale of Genzyme Genetics to Laboratory Corporation of America Holdings (NYSE: LH) for $925 million in cash.
Under the final terms of the agreement, LabCorp purchased substantially all of the assets of the Genzyme Genetics business, including testing services, technology, intellectual property rights, and the rights to continue operations at the unit’s nine genetic testing laboratories. All employees of Genzyme Genetics were offered similar positions at LabCorp.
This sale to LabCorp represents the successful completion of the first of three planned divestitures previously announced by Genzyme. Earlier this month, the company announced that it has entered into an asset purchase agreement under which Sekisui Chemical Co., Ltd. will acquire Genzyme’s Diagnostic products business for $265 million in cash. The company also plans to divest its Pharmaceuticals business. Proceeds from these three transactions may be used to finance the remaining half of the company’s planned $2 billion stock repurchase.
About Genzyme
One of the world's leading biotechnology companies, Genzyme is dedicated to making a major positive impact on the lives of people with serious diseases. Since 1981, the company has grown from a small start-up to a diversified enterprise with approximately 10,000 employees in locations spanning the globe and 2009 revenues of $4.5 billion. In 2010, Genzyme was named to the Fortune 500.
With many established products and services helping patients in 100 countries, Genzyme is a leader in the effort to develop and apply the most advanced technologies in the life sciences. The company's products and services are focused on rare inherited disorders, kidney disease, orthopaedics, cancer, transplant, and immune disease. Genzyme's commitment to innovation continues today with a substantial development program focused on these fields, as well as cardiovascular disease, neurodegenerative diseases, and other areas of unmet medical need.
Genzyme’s press releases and other company information are available at www.genzyme.com and by calling Genzyme’s investor information line at 1-800-905-4369 within the United States or 1-678-999-4572 outside the United States.
Important Information
Genzyme has filed with the Securities and Exchange Commission a Solicitation/Recommendation Statement on Schedule 14D-9 relating to the tender offer by Sanofi-Aventis. Genzyme shareholders are advised to read the company's Solicitation/Recommendation Statement on Schedule 14D-9 because it contains important information. Shareholders may obtain a free copy of the Solicitation/Recommendation Statement on Schedule 14D-9, as well as any other documents filed by Genzyme in connection with the tender offer, free of charge at the SEC's website at http://www.sec.gov. In addition, investors can obtain free copies of these documents from Genzyme by directing a request to Genzyme at 500 Kendall Street, Cambridge, MA 02142, Attention: Shareholder Relations Department, or by calling 617-252-7500 and asking for the Shareholder Relations Department.
Safe-Harbor
This press release contains forward-looking statements, including the statements regarding: the successful completion of the sale of Genzyme’s Diagnostic products business, the planned sale of Genzyme’s Pharmaceuticals business, and Genzyme’s plans for the use of the proceeds from one or more of the divestitures of its Genetics, Diagnostic products and Pharmaceuticals businesses. These statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected in these forward-looking statements. These risks and uncertainties include the failure of Genzyme to complete the sale of the Diagnostics products business; the failure of Genzyme to complete the sale of its Pharmaceuticals business; the determination by Genzyme not to proceed with its stock repurchase program as currently contemplated; the determination by Genzyme not to use all or a portion of the proceeds from the divestitures in connection with the stock repurchase program; and the risks and uncertainties described in Genzyme's SEC reports filed under the Securities Exchange Act of 1934, including the factors discussed under the caption "Risk Factors" in Genzyme's Quarterly Report on Form 10-Q for the period ended September 30, 2010. We caution investors not to place undue reliance on the forward-looking statements contained in this press release. These statements speak only as of the date of this press release, and we undertake no obligation to update or revise these statements.
http://ih.advfn.com/p.php?pid=nmona&article=45464369
SAE
14 years ago
Genzyme Successfully Meets First Milestones of FDA Consent Decree
Genzyme Corporation (NASDAQ: GENZ) announced today that the company has ended fill/finish operations within its Allston plant for products sold in the United States, as required by the FDA consent decree. All fill/finish activities for Cerezyme® (imiglucerase for injection), Myozyme® (alglucosidase alfa), Fabrazyme® (agalsidase beta) and Thyrogen® (thyrotropin alfa for injection) for the U.S. market now take place at Genzyme’s Waterford, Ireland plant, and at an external contract manufacturer. With this move, all previous restrictions on the marketing and distribution of Thyrogen within the United States have been lifted.
All remaining fill/finish activities in Allston for products sold outside of the United States must be ended by August 31, 2011. Genzyme is working closely with regulatory authorities globally to achieve this goal.
About Genzyme
One of the world's leading biotechnology companies, Genzyme is dedicated to making a major positive impact on the lives of people with serious diseases. Since 1981, the company has grown from a small start-up to a diversified enterprise with approximately 10,000 employees in locations spanning the globe and 2009 revenues of $4.5 billion. In 2010, Genzyme was named to the Fortune 500.
With many established products and services helping patients in 100 countries, Genzyme is a leader in the effort to develop and apply the most advanced technologies in the life sciences. The company's products and services are focused on rare inherited disorders, kidney disease, orthopaedics, cancer, transplant, and immune disease. Genzyme's commitment to innovation continues today with a substantial development program focused on these fields, as well as cardiovascular disease, neurodegenerative diseases, and other areas of unmet medical need.
Important Information
Genzyme has filed with the Securities and Exchange Commission a Solicitation/Recommendation Statement on Schedule 14D-9 relating to the tender offer by Sanofi-Aventis. Genzyme shareholders are advised to read the company's Solicitation/Recommendation Statement on Schedule 14D-9 because it contains important information. Shareholders may obtain a free copy of the Solicitation/Recommendation Statement on Schedule 14D-9, as well as any other documents filed by Genzyme in connection with the tender offer, free of charge at the SEC's website at http://www.sec.gov. In addition, investors can obtain free copies of these documents from Genzyme by directing a request to Genzyme at 500 Kendall Street, Cambridge, MA 02142, Attention: Shareholder Relations Department, or by calling 617-252-7500 and asking for the Shareholder Relations Department.
Genzyme’s press releases and other company information are available at www.genzyme.com and by calling Genzyme’s investor information line at 1-800-905-4369 within the United States or 1-678-999-4572 outside the United States.
Genzyme®, Cerezyme®, Myozyme®, Fabrazyme® and Thyrogen® are registered trademarks of Genzyme Corporation. All rights reserved.
This press release contains forward-looking statements, including the statements regarding: our ability to secure necessary regulatory approvals in advance of the August 31, 2011 deadline to end fill/finish manufacturing operations at Allston for product to be distributed outside of the United States. These statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected in these forward-looking statements. These risks and uncertainties include, among others, the ability to obtain necessary regulatory approvals in the United States and throughout the world in a timely manner, the ability of our third-party fill/finish manufacturer to successfully fill/finish our products, and the risks and uncertainties described in Genzyme's SEC reports filed under the Securities Exchange Act of 1934, including the factors discussed under the caption "Risk Factors" in Genzyme's Quarterly Report on Form 10-Q for the period ended September 30, 2010. We caution investors not to place undue reliance on the forward-looking statements contained in this press release. These statements speak only as of the date of this press release, and we undertake no obligation to update or revise these statements.
http://ih.advfn.com/p.php?pid=nmona&article=45377017
SAE
14 years ago
Two insightful letters, IMO-between CEO's of Genzyme and Sanofi-Aventis. Stockinvestor
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
SCHEDULE 14D-9
SOLICITATION/RECOMMENDATION STATEMENT
PURSUANT TO SECTION 14(d)(4) OF THE
SECURITIES EXCHANGE ACT OF 1934
(Amendment No. 8)
GENZYME CORPORATION
(Name of Subject Company)
GENZYME CORPORATION
(Name of Person(s) Filing Statement)
Common Stock, par value $0.01 per share
(Title of Class of Securities)
372917104
(CUSIP Number of Common Stock)
Peter Wirth
Executive Vice President
Genzyme Corporation
500 Kendall Street
Cambridge, Massachusetts 02142
(617) 252-7500
(Name, Address and Telephone Number of Person Authorized to Receive Notices
and Communications on Behalf of the Person(s) Filing Statement)
With copies to:
Paul M. Kinsella
Ropes & Gray LLP
Prudential Tower
800 Boylston Street
Boston, Massachusetts 02199
(617) 951-7000 Andrew R. Brownstein
Wachtell, Lipton, Rosen & Katz
51 West 52nd St
New York, New York 10019
(212) 403-1000
o Check the box if the filing relates solely to preliminary communications made before the commencement of a tender offer.
--------------------------------------------------------------------------------
TABLE OF CONTENTS
Item 4. The Solicitation or Recommendation.
Item 9. Exhibits.
SIGNATURE
Ex-(a)(23)
--------------------------------------------------------------------------------
Table of Contents
This Amendment No. 8 amends and supplements the Solicitation/Recommendation Statement on Schedule 14D-9 originally filed by Genzyme Corporation, a Massachusetts corporation (the “ Company ” or “ Genzyme ”), with the Securities and Exchange Commission (the “ SEC ”) on October 7, 2010 (as previously amended, the “ Schedule 14D-9 ”), relating to the unsolicited tender offer by GC Merger Corp., a Massachusetts corporation (“ Offeror ”) and wholly-owned subsidiary of Sanofi-Aventis, a French société anonyme (“ Sanofi ”), to purchase all of the outstanding shares of the Company’s common stock, par value $.01 per share (the “ Shares ”), at a purchase price of $69.00 per Share (the “ Offer Price ”), net to the selling shareholders in cash, without interest thereon and less any required withholding taxes, upon the terms and subject to the conditions set forth in the Offer to Purchase, dated October 4, 2010 (the “ Offer to Purchase ”), and in the related Letter of Transmittal (which, together with the Offer to Purchase, constitutes the “ Offer ”), included as Exhibits (a)(1)(A) and (a)(1)(B) to the Tender Offer Statement on Schedule TO (as amended or supplemented from time to time, the “ Schedule TO ”) filed by Sanofi and Offeror with the SEC on October 4, 2010.
Item 4. The Solicitation or Recommendation.
Item 4 of the Schedule 14D-9 is hereby amended and supplemented by adding the following after the paragraph starting “On October 5, 2010, the Strategic Planning Committee. . .” under the heading “(b) Background and Reasons for the Recommendation of the Company Board”:
On October 22, 2010, the Company held a meeting with investors and security analysts in New York to present the Company’s near-term financial outlook, report progress on the Company’s actions to enhance shareholder value, communicate expectations for the Company’s late-stage pipeline, and outline the reasons why the Offer dramatically undervalues the Company. A copy of the Company’s presentation, a copy of the Company’s press release announcing the key points presented at the meeting and a transcript of the Company’s presentation were filed as Exhibits (a)(21), (a)(22) and (a)(23), respectively, to this Schedule 14D-9. The Company subsequently met directly with several of the Company’s shareholders in the following days.
On November 8, 2010, Mr. Termeer received the following letter from Mr. Viehbacher and was asked to share it with the members of the Company Board:
November 8, 2010
VIA EMAIL, TELECOPIER AND DHL
Mr. Henri Termeer
Chairman, President and Chief Executive Officer
Genzyme Corporation
500 Kendall Street
Cambridge, Massachusetts 02147
USA
Dear Henri,
Now that Genzyme’s third-quarter earnings have been released, you have had the opportunity to speak to shareholders regarding Genzyme’s business and prospects (including the detailed presentation to analysts and investors on October 22) and the market has had a chance to digest and react to all of this information, we would again like to request that you meet with us to discuss our proposal to acquire Genzyme. We continue to believe that our proposal is compelling for your shareholders and would provide them with immediate and substantial value that reflects the potential of Genzyme’s business and pipeline.
You have publicly disclosed that Genzyme’s Board has authorized management and the company’s advisors to “probe and evaluate alternatives” for Genzyme and its assets, including contacting third parties. We were encouraged to hear this, but to date, we have not been contacted or included in this process. We are prepared to meet with you and, if you prefer, with your advisors, at any time to discuss our respective views as to the appropriate value of Genzyme’s business and prospects and how to move this transaction process forward in a cooperative manner. As you will recall, at our meeting in September, I proposed several pathways to advance our discussions, such as providing us with some limited due diligence regarding manufacturing or arranging a meeting with your commercial team to discuss the prospects for alemtuzumab. We remain ready and willing to participate in any such meetings.
You have expressed publicly (and, we understand, directly during your conversations with Genzyme shareholders) that you are committed to maximizing shareholder returns and that you value shareholders’ voices. However, we note certain comments in your Schedule 14D-9 that appear to be inconsistent with that objective.
First, you indicated that you believe that the Genzyme Board can, at any time, opt to immediately stagger the terms of its members, extending the terms of two-thirds of Genzyme’s current directors for an additional one to three years. This action would deprive shareholders of the opportunity to elect the full Genzyme Board at the 2011 annual meeting of shareholders, a right they expressly demanded. As you know, in 2006, holders of more than 85% of the outstanding shares of Genzyme common stock voted to approve an amendment to Genzyme’s Articles of Organization to provide that all directors would be elected annually. Given this, we do not believe that it would be appropriate for the Genzyme Board to disenfranchise shareholders by unilaterally staggering the terms of directors.
Second, you stated that the Genzyme Board retains the ability to adopt a “poison pill”. As you are well aware, if adopted, the poison pill would prevent Sanofi-Aventis from acquiring Genzyme, regardless of your shareholders’ support for a transaction.
Third, you indicated that the Genzyme Board may wield the Massachusetts anti-takeover statutes in a manner that would, as a practical matter, prevent Sanofi-Aventis from acquiring Genzyme without the cooperation of Genzyme’s Board, notwithstanding your shareholders’ support of a transaction.
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We believe it would be inappropriate for the Board to take these defensive actions. If we are unable to have a direct dialog with you, in all fairness you should allow your shareholders the opportunity to decide for themselves whether or not to accept our proposal.
Your shareholders should know with certainty that you will not interfere with their right to benefit from our offer by taking any of the actions described above. Therefore, we ask that you take action to make the Massachusetts anti-takeover statute inapplicable to our offer and confirm that Genzyme’s 2011 annual meeting of shareholders, including the election of all directors, will be held on schedule on the fourth Thursday of May (May 26, 2011), as provided in your Bylaws.
It remains our preference to work together with you to reach a mutually agreeable transaction. We continue to believe that a transaction is in the best interests of the shareholders of both Genzyme and Sanofi-Aventis, and we look forward to hearing from you.
Yours sincerely,
Sanofi-Aventis
By: /s/ Christopher A. Viehbacher
Christopher A. Viehbacher
Chief Executive Officer
cc: Genzyme Board of Directors
On November 8, 2010, Mr. Termeer sent the following response letter to Mr. Viehbacher:
November 8, 2010
Mr. Christopher A. Viehbacher
Chief Executive Officer
Sanofi-Aventis
174, avenue de France
75635 Paris, Cedex 13
Dear Chris,
Since we last met, Genzyme has provided the marketplace with detailed reports on our significant progress and detailed information about our near-term plans and future prospects, including the results of an independent third party study of alemtuzumab’s revenue potential. Sanofi-Aventis, for its own purposes, has chosen to dismiss or ignore this information and stick to its opportunistic and inadequate $69.00 per share offer, even as analysts have adjusted their targets to reflect the new information we have shared and we continue to have the support of our shareholders.
As we have repeatedly told Sanofi — and as our Lead Independent Director reaffirmed during our Investor Meeting — our Board is unanimous in its view that the $69.00 offer is not an appropriate starting point for the discussions Sanofi seeks. Our shareholders understand and support this position. In addition, as our Board has also made clear, we are open to a transaction that appropriately recognizes Genzyme’s intrinsic value and prospects. We will meet with Sanofi if it makes an offer that gives our Board of Directors reason to believe it will lead to that result.
Our Board is committed to taking all appropriate actions in the best interests of Genzyme and its shareholders and we have done, are doing, and will continue to do, exactly that.
Sincerely,
/s/ Henri A. Termeer
Henri A. Termeer
Chairman and Chief Executive Officer
Item 4 of the Schedule 14D-9 is hereby amended by replacing the second to last paragraph under the heading “(b) Background and Reasons for the Recommendation of the Company Board” with the following:
The Company Board recommended that management embark on a program to communicate with the Company’s shareholders about the intrinsic value of the Company. Accordingly, on October 22, 2010, the Company held a meeting with investors and security analysts in New York to present the Company’s near-term financial outlook, report progress on the Company’s actions to enhance shareholder value, communicate expectations for the Company’s late-stage pipeline, and outline the reasons why the Offer dramatically undervalues the Company. A copy of the Company’s presentation, a copy of the Company’s press release announcing the key points presented at the meeting and a transcript of the Company’s presentation were filed as Exhibits (a)(21), (a)(22) and (a)(23), respectively, to this Schedule 14D-9. The Company subsequently met directly with several of the Company’s shareholders in the following days.
Item 9. Exhibits.
Item 9 of the Schedule 14D-9 is hereby amended and supplemented by adding the following thereto:
Exhibit No. Description
(a)(23) Press release issued by Genzyme, dated November 8, 2010.
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SIGNATURE
After due inquiry and to the best of my knowledge and belief, I certify that the information set forth in this statement is true, complete and correct.
Dated: November 8, 2010 GENZYME CORPORATION
By: /s/ Thomas J. DesRosier
Name: Thomas J. DesRosier
Title: Senior Vice President, General Counsel
and Chief Legal Officer
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SAE
14 years ago
2nd UPDATE: Genzyme Drug In Short Supply From Allston Delay
Genzyme Corp. (GENZ) is dealing with a shortage of its Thyrogen cancer treatment due to a delay at its long-troubled Allston, Mass., production plant.
The Cambridge, Mass., biotechnology company expects to have the drug available again in mid- to late November, but will provide a status update on that timeline by next week. A company spokeswoman said the shortage is due to an equipment-related delay in Allston, but said that no other products are currently impacted by the problem.
The company's top-selling products, rare-disease treatments Cerezyme and Fabrazyme, are recovering from shortages that stemmed from a contamination-related shutdown of the plant last year.
Genzyme's business has been damaged by manufacturing and regulatory problems in recent years, leading to the long-term regulatory oversight of the Allston facility. As part of that oversight, production of Thyrogen was restricted to a level that meets the needs of patients for whom the Food and Drug Administration deemed the drug to be medically necessary. The drug, which had $170.6 million in sales last year, is used in the treatment and follow-up diagnosis of thyroid cancer.
The FDA's restrictions will be in place until Thyrogen produced at another location becomes available.
The last stage of Thyrogen's production, called fill and finish, occurs at the Allston plant and the main manufacturing is done at a plant in Framingham, Mass. Genzyme is in the process of moving its fill and finish operations out of Allston, as required under a consent decree with the FDA.
The Genzyme spokeswoman said the delay doesn't affect its plans to move those operations.
The latest problem stems from the need to "re-validate" equipment that is used in the fill-and-finish process.
The move, which involves running the equipment three times to ensure consistent results, is done to make sure the it is running properly as part of standard manufacturing practices. The process must be completed before Thyrogen can be released for shipping, the Genzyme spokeswoman said.
The fallout from the Allston problems and resulting drug shortages led to changes at the company and its board, along with a turnaround program that includes cutting costs and shedding noncore businesses.
Separately on Friday, Genzyme said it began the first wave of its layoff program by eliminating 392 jobs, expected to result in a fourth-quarter charge of $24 million to $27 million. The move is part of the company's previously announced program to cut 1,000 jobs over 15 months.
Genzyme is in the midst of a takeover pursuit from French drug giant Sanofi-Aventis SA (SNY, SAN.FR). Genzyme has repeatedly rejected Sanofi's $18.5 billion bid as too low and refused to negotiate on a better price. The offer, amounting to $69 a share, has since turned hostile, and Genzyme has recommended that shareholders do not surrender their shares.
Shares of Genzyme closed down 1 cent at $71.69.
-By Thomas Gryta, Dow Jones Newswires; 212-416-2169; thomas.gryta@dowjones.com
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SAE
14 years ago
Genzyme Announces Results of Phase 3 Trial of Clolar in Adult AML
Genzyme Corporation (Nasdaq: GENZ) announced results today from its CLASSIC I phase 3 trial comparing Clolar® (clofarabine) in combination with the chemotherapy agent cytarabine (ara-c) to cytarabine plus placebo in relapsed-refractory adult acute myeloid leukemia (AML). Although the study did not show a difference between the arms in the primary endpoint of overall survival, the Clolar combination demonstrated statistical significance across all four pre-specified secondary efficacy endpoints: overall remission rate; complete remission rate; event-free survival; and four-month event free survival.
“Of importance, the Clolar combination doubled the overall remission rate to 47 percent,” said Hagop Kantarjian, M.D., MD Anderson Cancer Center. “Also, we see a 37 percent improvement in event-free survival, a particularly important measure of clinical benefit.”
Preliminary review of adverse events revealed no new safety signals.
“We remain committed to the development of Clolar in adult acute myeloid leukemia,” said Mark Enyedy, Genzyme President of Transplant, Oncology, and Multiple Sclerosis. “We are collaborating with the United Kingdom’s National Cancer Research Institute on a large randomized clinical trial in front-line adult AML.” Data from this study is anticipated in 2011.
The CLASSIC I study was a randomized, double-blind, placebo-controlled clinical trial that compared Clolar in combination with cytarabine to cytarabine plus placebo in patients 55 years and older with AML who relapsed or were refractory after receiving up to two prior induction regimens. The combination of Clolar with cytarabine was developed by Stefan Faderl, M.D. and colleagues at the MD Anderson Cancer Center. Dr. Faderl served as the principal investigator of CLASSIC I, which enrolled 326 patients in North America and Europe. The event driven trial was powered to detect at least a 50 percent improvement in overall median survival in the Clolar plus cytarabine combination arm.
The CLASSIC I study results will be submitted to an upcoming medical meeting and discussed with regulatory authorities.
About Genzyme
One of the world's leading biotechnology companies, Genzyme is dedicated to making a major positive impact on the lives of people with serious diseases. Since 1981, the company has grown from a small start-up to a diversified enterprise with approximately 10,000 employees in locations spanning the globe and 2009 revenues of $4.5 billion. In 2010, Genzyme was named to the Fortune 500.
With many established products and services helping patients in 100 countries, Genzyme is a leader in the effort to develop and apply the most advanced technologies in the life sciences. The company's products and services are focused on rare inherited disorders, kidney disease, orthopaedics, cancer, transplant, and immune disease. Genzyme's commitment to innovation continues today with a substantial development program focused on these fields, as well as cardiovascular disease, neurodegenerative diseases, and other areas of unmet medical need.
This press release contains forward-looking statements regarding Genzyme’s future plans and business strategies, including its expectations about the timing of results from the front-line adult AML clinical trial and anticipated discussions with regulatory authorities about the CLASSIC I study results. These statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected in these forward-looking statements, including the outcome and timing of the front-line adult AML trial, the timing and outcome of discussions with regulatory agencies regarding Clolar, the actual safety and efficacy of Clolar for the indications in which it is being tested and the risks and uncertainties described in reports filed by Genzyme with the Securities and Exchange Commission under the Securities Exchange Act of 1934, as amended, including without limitation the information under the heading “Risk Factors” in Genzyme’s Quarterly Report on Form 10-Q for the quarter ending June 30, 2010. Genzyme cautions investors not to place substantial reliance on the forward-looking statements contained in this press release. These statements speak only as of the date of this press release, and Genzyme undertakes no obligation to update or revise these statements.
Genzyme® and Clolar® are registered trademarks of Genzyme Corporation or its subsidiaries. All rights reserved.
Genzyme’s press releases and other company information are available at www.genzyme.com and by calling Genzyme’s investor information line at 1-800-905-4369 within the United States or 1-678-999-4572 outside the United States.
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SAE
14 years ago
Genzyme Reports Financial Results for the Third Quarter of 2010
Genzyme Corp. (NASDAQ: GENZ) today reported third-quarter earnings growth driven by increased shipments of Cerezyme® (imiglucerase for injection). Patients in the United States began returning to normal dosing levels last month, and patients globally are expected to be able to do so this quarter. Earnings growth in the third quarter was also driven by strong revenue from Lumizyme™ (alglucosidase alfa) and cost reduction measures.
Third-quarter revenue was $1.0 billion, compared with $923.8 million in the same period last year. Operating results for the third quarter of 2009 have been revised to exclude the Genetics and Diagnostics businesses, which the company is planning to divest by the end of this year.
GAAP net income was $69.0 million, or $0.26 per diluted share, compared with $16.0 million, or $0.06 per diluted share, in the third quarter of 2009. Non-GAAP net income was $111.5 million, or $0.42 per diluted share, in line with the company’s guidance, compared with $77.9 million, or $0.28 per diluted share, in the same period last year. Non-GAAP net income excludes stock compensation expenses, costs associated with the acquisition of oncology products from Bayer, and the operations of the Genetics and Diagnostics businesses, as they meet the criteria of discontinued operations. At the end of the third quarter, Genzyme’s cash balance was approximately $1.2 billion.
“In the third quarter we saw our financial recovery start to take effect, and we expect that this will accelerate during the fourth quarter as Cerezyme patients are able to return to normal dosing levels and we begin to increase shipments of Fabrazyme,” said Henri A. Termeer, Genzyme’s chairman and chief executive officer. “We are also implementing measures to reduce our operating costs, while remaining focused on the priorities of transforming our manufacturing operations, strengthening our core genetic disease business, and advancing key pipeline programs to ensure sustainable long-term growth.”
During the third quarter, Genzyme made progress in executing its plan to increase shareholder value. The company last month announced that it entered into an asset purchase agreement under which Laboratory Corporation of America Holdings will acquire Genzyme Genetics for $925 million in cash. Plans to divest the Diagnostics and Pharmaceuticals businesses remain on track.
Genzyme completed the first half of a planned $2 billion share repurchase, financed by a $1 billion debt offering. The company has repurchased approximately 15.7 million shares at an approximate average price of $63.90. At the end of the second quarter, the company had 265.3 million basic weighted average shares outstanding. As a result of the buyback, this was reduced to 255.4 million at the end of the third quarter. Approximately 4 million shares of the repurchase were offset by the exercise of stock options. Proceeds from the divestitures of the Genetics, Diagnostics and Pharmaceuticals businesses may be used to finance the second half of the repurchase.
Cerezyme revenue in the fourth quarter is expected to be $235 – $245 million and Fabrazyme® (agalsidase beta) revenue is expected to be $70 – $75 million, based on currently anticipated product release dates. Non-GAAP EPS is expected to be $0.90 - $0.95 per diluted share in the fourth quarter.
Product Supply and Consent Decree Updates
Cerezyme’s recovery passed a major milestone with the return to full supply. Patients in the United States were able to begin returning to normal dosing levels in September, and patients globally are expected to be able to do so during the fourth quarter. Genzyme has begun the process of doubling allocations of Fabrazyme, starting in the United States, and will do so globally throughout the fourth quarter. The company expects to be able to fully supply the global market during the first half of 2011.
Since levels of demand, ordering patterns and dose regimens vary by region, Genzyme staff in countries around the world will provide patients and physicians with more information on the local impact of this guidance for each product. Because inventories remain limited, any manufacturing disruptions or delays in product release can impact availability of Cerezyme and Fabrazyme.
Genzyme is on schedule to meet the November consent-decree deadlines for ceasing fill/finish at its Allston plant for products sold in the United States. The company has transferred a significant portion of this work to its state-of-the-art facility in Waterford, Ireland, and is in the process of transferring the remainder to a third-party manufacturer, where initial lot release has begun.
The company’s new Framingham manufacturing facility is operational with Fabrazyme engineering runs underway, and approval is anticipated in late 2011. Engineering runs are ongoing at the newly expanded fill/finish operations in Waterford, and regulatory approval is expected in the second half of 2011.
Third Quarter Results and Business Updates
Within the Personalized Genetic Health segment, third-quarter sales of Myozyme/Lumizyme increased 24 percent to $106.2 million from $86.0 million in the same period in 2009, reflecting the recent U.S. launch of Lumizyme. Third-quarter revenue increased 15 percent from second-quarter sales of $92.1 million. U.S. Myozyme/Lumizyme sales increased from $4.4 million in the second quarter to $19.1 million in the third quarter, and are expected to reach $30 million in the fourth quarter.
Third-quarter sales of Cerezyme nearly doubled to $179.8 million from $93.6 million in the same period in 2009, and grew 30 percent from $138.7 in the second quarter of this year, reflecting increasing shipments. Sales of Fabrazyme were $33.9 million, compared with $115.2 million in the third quarter of last year, reflecting supply constraints and the timing of lot releases during the quarter.
Within the Biosurgery segment, sales of Synvisc® (hylan G-F 20) increased 14 percent to $100.0 million from $87.5 million in last year’s third quarter. Synvisc, which is impacted by seasonal variability, continues to gain market share, and now represents 46 percent of the U.S. viscosupplement market. The single injection product, Synvisc-One® (hylan G-F 20), was launched in March 2009 and currently comprises more than two-thirds of all U.S. Synvisc revenue. During the third quarter, Genzyme also received regulatory approval of Synvisc in Japan, the largest market in the world for viscosupplement products.
Total revenue for the Renal and Endocrinology segment grew to $270.4 million from $260.4 million in the same period last year. Within this segment, sales of Genzyme’s sevelamer therapies, Renvela® (sevelamer carbonate) and Renagel® (sevelamer hydrochloride), were $178.8 million, compared with $181.7 million during the third quarter of 2009, reflecting the product mix shift from Renagel to Renvela.
U.S. sevelamer volume increased by nearly 8 percent compared to the third quarter of 2009. Genzyme remains the market leader in the United States, with approximately 52 percent of the phosphate binder market. In July, U.S. Medicare and Medicaid Services issued its final rule regarding bundling; oral medications without IV equivalents, including Renvela, will not be included in the bundle until January 1, 2014.
Genzyme recently won a highly competitive, $28 million tender over generic manufacturers in Brazil, the second-largest market for Renagel outside of the United States. This is the second consecutive year that Genzyme has won this federal tender, which will begin impacting revenue starting this quarter. The European launch of Renvela continues to progress well; the product was introduced in Spain last month and in the key markets of France, Italy and the U.K. this month.
Sales of Thyrogen were $42.3 million compared with $41.7 million in the third quarter of 2009, despite the limitations on the promotion of Thyrogen in the U.S. that are contained in the consent decree. Once fill/finish operations are successfully transferred to a third-party manufacturer and fill/finish for Thyrogen for the U.S market is no longer occurring at the Allston facility, the promotional limitations will no longer be in effect and Genzyme will resume normal U.S. promotional work. This is expected to occur by the end of next month.
Total revenue for the Hematology and Oncology segment increased 17 percent to $167.3 million from $143.6 million in last year’s third quarter. Growth was driven by sales of Mozobil® (plerixafor injection), which increased 83 percent to $23.6 million from $12.9 million in the third quarter last year, reflecting a strong increase in U.S. sales and the ongoing launch in Europe.
Third-quarter growth in this segment was also driven by sales of Clolar® (clofarabine injection), which increased 23 percent to $26.1 million from $21.2 million in the third quarter of 2009, led by a 31 percent increase in U.S. volume.
Gross Margin
The GAAP gross margin for the third quarter was 69 percent of revenue, compared with 70 percent in the third quarter of 2009, and the non-GAAP gross margin was 70 percent of revenue, compared with 72 percent in the same quarter last year. Gross margin reflects changes in product mix and investments made to improve the company’s quality operations, including costs associated with Genzyme’s third-party consultant, Quantic.
In the fourth quarter, non-GAAP gross margin is expected to be 74 percent of revenue, reflecting increased capacity utilization associated with the resupply of Cerezyme and Fabrazyme, and favorable product mix.
Operating Expenses
Genzyme’s GAAP SG&A was $337.9 million, or approximately 34 percent of revenue, compared with $323.5 million, or approximately 35 percent of revenue in the third quarter of 2009. Non-GAAP SG&A was $312.7 million, or approximately 31 percent of revenue, compared with $301.2 million, or approximately 33 percent of revenue, in the same period last year.
The company’s GAAP R&D was $207.1 million compared with $215.9 million in last year’s third quarter; non-GAAP R&D was $193.3 million compared with $202.2 million in the third quarter of 2009.
During the third quarter, Genzyme began reducing spending in advance of the implementation of the Value Improvement Program, which is beginning this quarter and intended to significantly reduce operating costs and improve margins over the next 15 months, with the full impact seen by 2012. Fourth-quarter savings resulting from this program are expected to be $0.05 per share, which is already accounted for in the fourth-quarter non-GAAP EPS guidance of $0.90 – $0.95.
Late-Stage R&D Programs
Genzyme’s late-stage pipeline features three novel treatments that are expected to help drive the company’s long-term growth:
Genzyme last week presented five-year data from the phase 2 trial of alemtuzumab in multiple sclerosis at the Congress of the European Committee for Treatment and Research in Multiple Sclerosis. Data from a sub-group analysis showed that clinical outcomes persist at 60 months. Nearly 90 percent of alemtuzumab-treated patients were free of sustained accumulation of disability and maintained improved mean disability scores and a low risk of relapse over the 60-month follow-up period, with no changes in the safety profile. Two phase 3 studies are ongoing and data are expected beginning in mid-2011. The company expects to file for U.S. and E.U. approval in early 2012, and has been granted fast track status by the FDA for this submission.
Genzyme and Isis Pharmaceuticals Inc. reported in August that phase 3 studies of mipomersen in severe hypercholesterolemia and high-risk patients met their primary endpoints with 36 and 37 percent LDL-C reductions. These two studies, along with two additional phase 3 trials that have already been completed, will contribute to the initial U.S. and E.U. regulatory filings for the product, which will seek approval for the treatment of patients with the genetic disease homozygous familial hypercholesterolemia (FH). These two filings may also include patients with severe heterozygous FH, and are anticipated in the first half of 2011.
Enrollment is underway in three global, multi-center, phase 3 trials of eliglustat tartrate, Genzyme’s investigational oral therapy for patients with Gaucher disease type 1. There are currently a total of 65 active sites for these trials, with additional sites preparing to begin enrollment. Two-year follow-up data from the phase 2 clinical trial of the treatment were recently published in the journal Blood, and indicate continued improvements across all endpoints. Thirty-month data from the trial will be presented at the American Society of Human Genetics annual meeting next month. This therapy has the potential to transform the treatment experience for patients by providing an oral capsule option instead of bi-weekly infusions....
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SAE
14 years ago
Sanofi-Aventis to lay off 1,700 US employeesSanofi has been attempting such a deal since late July, when it offered $18.5 billion, or $69 a share, for Genzyme,...
Sanofi-Aventis to eliminate 1,700 jobs in US drug sales, administration to cut costs
Linda A. Johnson, AP Business Writer, On Friday October 8, 2010, 1:51 pm EDT
TRENTON, N.J. (AP) -- Sanofi-Aventis SA, the world's fourth-biggest drugmaker, said Friday it is eliminating 1,700 jobs in its U.S. pharmaceutical business in a restructuring triggered by growing generic competition and other factors.
The news comes as Sanofi's struggle to buy U.S. biotech firm Genzyme Corp. drags on.
The layoffs amount to about 25 percent of the workers in the company's U.S. pharmaceutical business, and will primarily hit sales representatives around the country and administrative staff at Sanofi's American headquarters in Bridgewater, N.J.
About 1,400 sales staff will be laid off, as well as about 300 staff in various administrative jobs, Sanofi-Aventis spokesman Jack Cox said.
"Barring any unforeseen events, we do believe the changes we're making now will make us the right size (in the U.S.) for our product portfolio through 2013, when we expect to return to growth," Cox said.
Three of Sanofi's top four products -- blockbuster anticlotting medicines Lovenox and Plavix and cancer drug Taxotere -- have new generic competition or will get it soon, jeopardizing just more than $10 billion of the company's $40 billion in annual sales.
The cuts announced Friday amount to 1.6 percent of the 105,000 employees worldwide and about 13 percent of Sanofi's entire U.S. work force of 13,000. That includes U.S. workers in research and development, manufacturing, the Sanofi-Pasteur vaccines business and the consumer products subsidiary Chattem.
Decisions on which employees will go are to be completed by mid-December, with the cuts being completed throughout 2011 according to transition needs, Cox said.
"Given the serious challenges facing our organization and the health care industry, it is important to act decisively now so that our organization has greater stability moving forward and that our resources are allocated to our strategic growth priorities," Gregory Irace, president and chief executive of Sanofi's U.S. and Canadian pharmaceutical operations, said in a statement.
He announced the layoffs to employees Friday morning during a meeting webcast to pharmaceutical employees around the country.
The company said the move will allow it to focus people and resources on key areas for the American pharmaceutical business -- medicines to treat diabetes, cancer and irregular heart beat that can lead to stroke and death.
Sanofi has had other layoffs or restructurings in the last few years, including reductions in its U.S. sales force June and last November, and downsizing of a research and development plant in Great Valley, Pa., Cox said. The company is closing a manufacturing plant in Kansas City in phases through 2012, eliminating about 300 jobs there.
Also in June, Paris-based Sanofi said it was offering voluntary buyouts to an unspecified number of employees in France, plus closing four research sites and possibly selling a fifth one there. Those sites employed about 650 people at the time. The company said it was not planning any layoffs there.
Restructurings have become routine in the pharmaceutical industry. They are driven primarily by two factors: the expiration of patents on numerous multibillion-dollar drugs launched during the industry's golden era in the 1990s and the companies' failure to develop enough new big sellers to replace those lost revenues.
Mergers of pharmaceutical companies, as well as their acquisitions of smaller consumer health and biotech companies, in recent years have been aimed at boosting current and future revenues. Those deals are resulting in additional restructuring programs and job cuts.
Sanofi has been attempting such a deal since late July, when it offered $18.5 billion, or $69 a share, for Genzyme, of Cambridge, Mass., which makes some lucrative drugs for rare genetic disorders and has other promising drugs in testing.
Genzyme's board has turned down the offer as too low three times, most recently late Thursday. Three days before that, Sanofi initiated a hostile takeover attempt and gave Genzyme stockholders until Dec. 10 to tender their shares.
In a filing with the U.S. Securities and Exchange Commission, Genzyme said that during a Sept. 20 meeting of the companies' chief executives, Sanofi CEO Chris Viehbacher "proposed the parties agree to a price range of from $69 per share to $80 per share."
Sanofi spokesman Jean-Marc Podvin denied that on Friday.
"We offered no price range, and Genzyme continues to refuse to engage with us on valuation" of the company, Podvin told The Associated Press.
He said he could not comment on what Sanofi's next step will be, but said its tender offer remains open.
In afternoon trading in New York, Sanofi-Aventis shares were up 7 cents at $34.11, while Genzyme shares were up 47 cents at $72.83.
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MinnieM
14 years ago
Genzyme Board Unanimously Rejects Sanofi-Aventis Tender Offer
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Genzyme Corp. (NASDAQ: GENZ) announced today that its board of directors has voted unanimously to reject the unsolicited $69.00 per share tender offer from Sanofi-Aventis, and the board recommends that Genzyme shareholders not tender their shares to Sanofi-Aventis pursuant to the offer. The board considered the following factors, among others, when making its recommendation:
• The offer is based on identical financial terms to two previous unsolicited proposals submitted by Sanofi-Aventis, both of which were rejected by the board. The board remains unanimously resolute in its belief that the offer price of $69.00 per share is inadequate and opportunistic, substantially undervalues the company, fails to recognize the company’s plan to increase shareholder value, and is not in the best interests of Genzyme or its shareholders.
• The offer fails to compensate shareholders for the value of Genzyme’s existing business, which delivered compound annual revenue growth of 23 percent from 2002-2009. This business includes a unique and longstanding leadership position in the orphan-drug market; 12 market-leading products with durable revenue streams; and a long history of research and development productivity and success.
• The offer fails to recognize the value-creation impact of the company’s five-point plan. Under this plan, Genzyme is focusing on its core business and working to establish operational excellence in manufacturing; capitalizing on near-term growth drivers; divesting non-core businesses; reducing operating costs and improving margins; and optimizing its capital structure. Genzyme has made significant progress in implementing this plan, and the board believes that—given the opportunity to fully execute the plan—the company has the potential to generate substantially more value for shareholders than the offer price. The company also has an opportunity to further deploy its substantial prospective free cash flow to maximize value for shareholders.
• The offer fails to reflect Genzyme’s valuable late-stage pipeline, which includes three breakthrough products that are expected to be launched by the end of 2013. Foremost among these products is alemtuzumab, a potentially transformative therapy for multiple sclerosis. Phase 3 clinical trial results for this drug will be available in the middle of next year. Based on the robust clinical results reported to date from the phase 2 study, and the possibility for once yearly dosing, alemtuzumab has the potential to capture a material share of a global MS market that is projected to reach $14 billion when the product is first launched in 2012, offering an exciting revenue opportunity that will result in significant value for shareholders.
• The offer price does not adequately compensate Genzyme’s shareholders for the strategic importance and financial benefit to Sanofi-Aventis of a potential transaction with Genzyme.
The full basis for the board’s recommendation is set forth in a Solicitation/Recommendation Statement on Schedule 14D-9, which was filed by Genzyme today with the Securities and Exchange Commission.
Genzyme’s board and management are initiating a program to communicate with shareholders regarding the intrinsic value of the company. In the near future, Genzyme will hold an Analyst and Investor meeting in New York to provide a financial outlook and other pertinent information. The event will be web cast on the investor events section of www.genzyme.com. Details of the meeting will be announced separately. On October 21, following the release of its third-quarter earnings results, the company will begin a series of meetings with shareholders.
Genzyme’s financial advisors are Credit Suisse and Goldman, Sachs & Co., and its legal advisor is Ropes & Gray LLP. The legal advisor for Genzyme’s independent directors is Wachtell, Lipton, Rosen & Katz.
About Genzyme
One of the world's leading biotechnology companies, Genzyme is dedicated to making a major positive impact on the lives of people with serious diseases. Since 1981, the company has grown from a small start-up to a diversified enterprise with more than 12,000 employees in locations spanning the globe and 2009 revenues of $4.5 billion. In 2010, Genzyme was named to the Fortune 500.
With many established products and services helping patients in 100 countries, Genzyme is a leader in the effort to develop and apply the most advanced technologies in the life sciences. The company's products and services are focused on rare inherited disorders, kidney disease, orthopaedics, cancer, transplant, and immune disease. Genzyme's commitment to innovation continues today with a substantial development program focused on these fields, as well as cardiovascular disease, neurodegenerative diseases, and other areas of unmet medical need.
This press release contains forward-looking statements, including without limitation, statements regarding: Genzyme’s potential to generate substantially more value for shareholders than the offer price by executing its five-point plan and further deploying its prospective free cash flow; the prospects of its late-stage pipeline, including expected launch dates and market potential. These forward-looking statements are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by forward-looking statements. These risks and uncertainties include, but are not limited to: that Genzyme is unable to recognize value from any or all of it’s five-point plan due to manufacturing problems, clinical trial set-backs, or any other reason; that one or more of Genzyme’s late-stage pipeline products is unsuccessful; that the offer makes it more difficult for Genzyme to maintain relationships with employees, customers, suppliers and other business partners; that shareholder litigation brought in connection with the offer will result in significant defense, indemnification and liability costs; risks associated with development, manufacturing and commercialization of Genzyme’s products and product candidates; and other risks and uncertainties discussed in the Company’s filings with the SEC, including the information referred to under the heading “Risk Factors” section of the Company’s quarterly report on Form 10-Q for the quarter ended June 30, 2010. The Company does not undertake any obligation to update any forward-looking statements, which speak only as of the date of this press release.
Important Information
Genzyme has filed with the Securities and Exchange Commission a Solicitation/Recommendation Statement on Schedule 14D-9. Genzyme shareholders are advised to read the company's Solicitation/Recommendation Statement on Schedule 14D-9 because it contains important information. Shareholders may obtain a free copy of the Solicitation/Recommendation Statement on Schedule 14D-9, as well as any other documents filed by Genzyme in connection with the tender offer by Sanofi-Aventis, free of charge at the SEC's website at http://www.sec.gov. In addition, investors and security holders can obtain free copies of these documents from Genzyme by directing a request to Genzyme at 500 Kendall Street, Cambridge, MA 02142, Attention: Shareholder Relations Department, or by calling 617-252-7500 and asking for the Shareholder Relations Department.
Genzyme’s press releases and other company information are available at www.genzyme.com and by calling Genzyme’s investor information line at 1-800-905-4369 within the United States or 1-678-999-4572 outside the United States.
MinnieM
14 years ago
Sanofi Begins $18.5 Billion Hostile Offer for Genzyme
http://www.bloomberg.com/news/2010-10-04/sanofi-begins-18-5-billion-hostile-takeover-offer-for-genzyme.html
By Albertina Torsoli and Meg Tirrell - Oct 4, 2010 12:13 AM PT
Sanofi-Aventis SA began an $18.5 billion hostile takeover offer for Genzyme Corp. after the U.S. biotechnology company spurned Sanofi’s $69-a-share bid as too low and refused to negotiate.
Sanofi, France’s largest drugmaker, started a tender offer to acquire all outstanding shares of Genzyme for $69 each, the Paris-based company said in a statement today. The offer expires on 11:59 p.m. in New York on Dec. 10.
“We believe the offer will be successful,” Sanofi Chief Executive Officer Chris Viehbacher said during a conference call with reporters today. While Sanofi is still open to talks with Genzyme, Viehbacher sees “no particular reason to bid more.” Sanofi is a “patient and disciplined buyer,” Viehbacher said.
Investors who own more than 50 percent of Genzyme indicated in meetings with Viehbacher that they were willing to sell their shares at “a reasonable price,” the 50-year-old executive said at a conference on Sept. 15. Conversations also “revealed that those shareholders were frustrated with Genzyme’s persistent refusal to have meaningful discussions regarding Sanofi-Aventis’ proposal,” he said.
Genzyme, based in Cambridge, Massachusetts, rejected the original offer as too low and has since “blocked at every turn” all of Sanofi’s efforts to negotiate, Viehbacher said today. A meeting between Viehbacher and Genzyme Chief Executive Officer Henri Termeer on Sept. 20 proved “unproductive,” and the two CEOs haven’t spoken since, Viehbacher said today.
‘Silly’
“If they can’t get through Genzyme’s management, they’d be silly not to approach the shareholders directly,” Phil Nadeau, an analyst at Cowen & Co. in New York, said in a Sept. 30 interview. Nadeau has an “outperform” rating on Genzyme.
Genzyme’s stock sank as much as 43 percent from its 2008 high after manufacturing glitches led to product shortages, leaving the company vulnerable to a takeover. Investor activists Carl Icahn and Ralph Whitworth of Relational Investors LLC gained control of board seats this year at Genzyme, the world’s largest maker of medicines for genetic diseases.
The deal would be the biggest hostile takeover offer in the drug industry since the transaction that created Sanofi-Aventis in 2004, according to Bloomberg data. Sanofi-Synthelabo acquired Aventis for about $64 billion after raising its bid once.
Shares Decline
Sanofi fell 28 cents, or 0.6 percent, to 48.02 euros at 9:12 a.m. in Paris trading. The stock has declined 13 percent this year. Genzyme rose 9 cents, or 0.1 percent, to $70.88 in Nasdaq Stock Market trading Oct. 1. The stock has closed above the value of Sanofi’s offer every day since the bid was made public Aug. 29.
Should Sanofi walk away, Genzyme shares probably would fall to the low- to mid-$50s, Nadeau said.
Cerezyme -- Genzyme’s best-selling medicine, with $793 million in sales last year -- is a mass-produced version of a human enzyme missing in patients with the inherited illness Gaucher disease.
Sanofi is seeking acquisitions to replace revenue the company is losing as some of its biggest-selling products, such as the blood thinner Plavix and the cancer drug Taxotere, face competition from generic medicines.
Genzyme’s drugs are less likely to face generic competitors because they’re made from living cells and are harder to copy than pills made from chemicals. The U.S. Food and Drug Administration designated the therapies as orphan drugs because they’re for diseases without other treatment options, giving them more patent protection.
Termeer said in August that he was open to selling the biotechnology company at a “fair value,” higher than $69 a share.
“It could be that he is just being a tough negotiator,” said Nadeau, the Cowen analyst. “He does have a fiduciary duty to Genzyme shareholders that they get the best possible price.”
To contact the reporter on this story: Albertina Torsoli in Paris at atorsoli@bloomberg.net; Meg Tirrell in New York at mtirrell@bloomberg.net
To contact the editor responsible for this story: Phil Serafino at pserafino@bloomberg.net Reg Gale at rgale5@bloomberg.net;
SAE
14 years ago
Synvisc Approved in Japan, Key Market for Viscosupplementation Products
Genzyme Corporation (Nasdaq: GENZ) announced today that Japan’s Ministry of Health, Labour and Welfare has approved Synvisc® (hylan G-F 20; 3 x 2 mL), indicated for the treatment of osteoarthritis of the knee. Reimbursement has been obtained and publicized by Japan’s Central Social Insurance Medical Council.
According to a recent Japanese epidemiological study (ROAD), nearly 30 million people in Japan have osteoarthritis (OA) of the knee. The existing viscosupplements on the market in Japan require a greater number of injections than Synvisc, and may offer a much shorter duration of pain relief. Synvisc, the first non-Japanese viscosupplement to be approved in the country, will be the only product to offer six months of OA knee pain relief with three injections. Genzyme plans to launch Synvisc in Japan by the end of this year.
Genzyme has entered into an agreement with Teijin Pharma Limited to commercialize Synvisc in Japan. Under the terms of the agreement, Teijin Pharma has exclusive commercialization rights for Synvisc in Japan, and will pay certain milestone payments and a predetermined supply price for the product. Teijin Pharma, a division of the multinational Teijin Group, has extensive commercial experience in the orthopaedic market in Japan through its active promotion of products for bone and joint health.
“Launching Synvisc in Japan supports the growth of the franchise globally,” said Alison Lawton, Senior Vice President and General Manager of Genzyme Biosurgery, the business unit of Genzyme that manufactures and markets Synvisc. “Teijin Pharma’s expertise in the Japanese orthopaedic arena gives us confidence that they will successfully launch Synvisc and gain market share.”
“The viscosupplement market in Japan is valued at more than $500 million and there is increasing demand for new treatment options,” said Osamu Nishikawa, President of Teijin Pharma Limited. “Doctors and patients will be pleased to have a new product available that provides OA knee pain relief with just three injections rather than multiple injection products which are currently on the market. We look forward to utilizing our extensive marketing and sales experience in the orthopaedics space to offer physicians and patients this therapeutic option.”
About Synvisc
Synvisc® (hylan G-F 20) is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative nonpharmacologic therapy and simple analgesics, e.g., acetaminophen.
Important Safety Information
Synvisc is contraindicated in patients with known hypersensitivity to hyaluronan products and in patients with infections in or around the target knee. Do not inject Synvisc extra-articularly, into the synovial tissues, into the fat pad or joint capsule, or intravascularly. The safety and efficacy of Synvisc in locations other than the knee, or for conditions other than osteoarthritis, or in combination with other intraarticular injectables have not been established. Use caution when using Synvisc in patients allergic to avian proteins, feathers, or egg products; who have evidence of lymphatic or venous stasis in the leg to be injected; or who have severe inflammation in the knee to be treated. Strict adherence to aseptic technique must be followed. Remove any synovial fluid or effusion before each Synvisc injection. Patients should be advised to avoid strenuous or prolonged weight-bearing activities for approximately 48 hours after treatment. The safety and effectiveness of Synvisc in children and in pregnant or lactating women have not been established. It is unknown whether Synvisc is excreted in human milk.
In clinical trials, the most commonly reported adverse events were transient local pain, swelling, and/or effusion in the injected knee. In some cases, these symptoms have been extensive. The most commonly reported systemic side effects were rash, fever, nausea, and headache.
About Viscosupplementation
Viscosupplementation is a treatment for patients with osteoarthritis (OA) in which hyaluronic acid is injected into the knee joint to replace degraded joint fluid. Normal joint fluid can act as a lubricant and a shock absorber. Viscosupplementation is an accepted therapy for OA pain that is both comparable to oral therapies, yet avoids toxicity and the associated risks of systemic therapy. This procedure is performed on an out-patient basis and requires little recovery time.
About Teijin Pharma Limited
Teijin Pharma Limited, the core company of Teijin Group's medical and pharmaceuticals business, focuses on three key therapeutic areas: respiratory, bone/joint, and cardiovascular/metabolic diseases. Teijin Pharma has strong marketing positions, particularly in the respiratory and bone/joint areas, with pharmaceutical products as well as a home healthcare business, including home oxygen therapy. Teijin Pharma continues to enhance its presence worldwide through in-house R&D as well as in-licensing and out-licensing activities. For more information, visit www.teijin-pharma.co.jp/english/index.html
About the Teijin Group
Based in Tokyo and Osaka, Japan, Teijin is a global technology-driven group operating in six main fields: high-performance fibers (aramid fibers and carbon fibers); polyester fibers; films and plastics; pharmaceuticals and home health care; trading and retail; and IT and new products. Teijin Limited, the holding company for the Teijin Group, is listed on the Tokyo and Osaka stock exchanges. The group had consolidated sales of USD 8.5 billion (JPY 765.8 billion, USD 1=JPY 90) in fiscal 2009 and employs 18,778 people worldwide, with 156 companies around the world. Please visit www.teijin.co.jp/english
About Genzyme
One of the world's leading biotechnology companies, Genzyme is dedicated to making a major positive impact on the lives of people with serious diseases. Since 1981, the company has grown from a small start-up to a diversified enterprise with more than 12,000 employees in locations spanning the globe and 2009 revenues of $4.5 billion. In 2010, Genzyme was named to the Fortune 500.
With many established products and services helping patients in approximately 100 countries, Genzyme is a leader in the effort to develop and apply the most advanced technologies in the life sciences. The company's products and services are focused on rare inherited disorders, kidney disease, orthopaedics, cancer, transplant and immune disease. Genzyme's commitment to innovation continues today with a substantial development program focused on these fields, as well as cardiovascular disease, neurodegenerative diseases, and other areas of unmet medical need.
Genzyme’s press releases and other company information are available at www.genzyme.com and by calling Genzyme’s investor information line at 1-800-905-4369 within the United States or 1-678-999-4572 outside the United States.
This press release contains forward-looking statements, including Genzyme’s plans to launch Synvisc in Japan by year end and its expectation that the product will gain market share. These statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected. These risks and uncertainties include, among others, the extent to which patients and doctors recognize the benefits of Synvisc and adopt it as a preferred treatment option and the risks and uncertainties described in reports filed by Genzyme with the U.S. Securities and Exchange Commission, including without limitation the factors discussed under the caption "Risk Factors" in Genzyme's Quarterly Report on Form 10-Q for the quarter ended June 30, 2010. We caution investors not to place undue reliance on the forward-looking statements contained in this press release. These statements speak only as of the date of this press release, and we undertake no obligation to update or revise the statements.
http://ih.advfn.com/p.php?pid=nmona&article=44438123&symbol=N%5EGENZ
SAE
14 years ago
Chmcnfunds,
This seems to be right on track to what I believe Genzyme had reported back in May...to sell off 3 of their non-core business units and use some of the proceeds to buyback the company's (GENZ) stock. Also, I am pleased to see that they have considered the existing employees and potentially important benefits to customers, in addition to stockholders, IMO. Stockinvestor
Genzyme Announces Agreement to Sell Genetic Testing Business to LabCorp
Genzyme Corporation (Nasdaq: GENZ) today announced that it has entered into an asset purchase agreement under which Laboratory Corporation of America Holdings (LabCorp) will acquire Genzyme Genetics for $925 million in cash.
Under the terms of the agreement, LabCorp will purchase the business in its entirety, including all testing services, technology, intellectual property rights, and its nine testing laboratories. LabCorp is committed to offer employment to the unit’s approximately 1900 employees upon closing, including senior management. The agreement is subject to customary closing conditions, including the Hart-Scott-Rodino Antitrust Improvements Act of 1976, with the goal of closing before the end of the year.
“This transaction demonstrates the strategic value of Genzyme Genetics and the strong franchise we’ve built over a twenty year period,” said Henri A. Termeer, chairman and chief executive officer of Genzyme Corporation. “It also shows how our management team is uniquely positioned to unlock the underappreciated value of Genzyme’s diverse businesses for shareholders. The completion of this sale allows us to focus our resources on core growth areas and create stronger returns on invested capital.”
Genzyme announced in May that it would seek strategic alternatives for three units as part of a five-part plan to increase shareholder value. The plan builds on the robust set of operational, organizational and board changes made over the past year to strengthen the company. Plans to divest the two other Genzyme business units, Diagnostic Products and Pharmaceutical intermediates, remain on track. Proceeds from these transactions may be used to finance the second half of the company’s $2 billion stock buyback to be completed by May 2011.
Genzyme Genetics is an industry leading provider of reproductive and oncology testing in the United States, specializing in esoteric testing, with nine laboratories performing more than a million tests a year. The business, which also has the largest nationwide network of board-certified genetic counselors, had revenue of $371 million in 2009. LabCorp is one of the nation’s largest laboratory testing companies specializing in routine testing, with 38 primary testing locations and more than 1,500 patient service centers.
The terms achieved with LabCorp meet the three foundational requirements Genzyme established for divestitures: (1) to recognize the value of employees with appropriate treatment as part of the transaction, (2) to create a future for Genzyme Genetics in which customers continue to be served well, and (3) to create value for Genzyme shareholders.
Mr. Termeer continued, “LabCorp is the right strategic partner for Genzyme Genetics. LabCorp intends to invest in growing its operations. The business will have the opportunity to continue to grow, serve its customers and fulfill its potential to bring continued innovation to important areas of the diagnostics field.”
Genzyme was advised by Credit Suisse and Goldman Sachs & Co on this transaction. The company’s legal adviser was Ropes & Gray.
About Genzyme
One of the world's leading biotechnology companies, Genzyme is dedicated to making a major positive impact on the lives of people with serious diseases. Since 1981, the company has grown from a small start-up to a diversified enterprise with more than 12,000 employees in locations spanning the globe and 2009 revenues of $4.5 billion. In 2010, Genzyme was named to the Fortune 500.
With many established products and services helping patients in approximately 100 countries, Genzyme is a leader in the effort to develop and apply the most advanced technologies in the life sciences. The company's products and services are focused on rare inherited disorders, kidney disease, orthopaedics, cancer, transplant and immune disease. Genzyme's commitment to innovation continues today with a substantial development program focused on these fields, as well as cardiovascular disease, neurodegenerative diseases, and other areas of unmet medical need.
This press release contains forward-looking statements, including the statements regarding: the timing and potential benefits of the proposed transaction; plans to focus on core growth areas and create stronger returns on invested capital; Genzyme’s five-part plan to increase shareholder value, the timing of divestitures of the Diagnostic Products and Pharmaceutical intermediates businesses; plans for the proceeds of the divestitures; and the timing of the $2 billion stock buyback program. These statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected in these forward-looking statements. These risks and uncertainties include, among others, the possibility that certain closing conditions will not be met; that the divestitures and stock buyback program do not occur in the anticipated timeframes for any reason; that any or all of Genzyme’s five-part plan to create shareholder value cannot be executed on or is otherwise ineffective; and the risks and uncertainties described in Genzyme's SEC reports filed under the Securities Exchange Act of 1934, including the factors discussed under the caption "Risk Factors" in Genzyme's Annual Report on Form 10-Q for the period ended June 20, 2010. We caution investors not to place undue reliance on the forward-looking statements contained in this document. These statements speak only as of the date of this document, and we undertake no obligation to update or revise the statements.
http://ih.advfn.com/p.php?pid=nmona&article=44338590&symbol=N%5EGENZ
SAE
14 years ago
Data from Mipomersen Phase 3 Trial in heFH Patients Presented at ESC
Genzyme Corp. (NASDAQ: GENZ) and Isis Pharmaceuticals Inc. (NASDAQ: ISIS) announced that data from the phase 3 study of mipomersen in patients with heterozygous familial hypercholesterolemia (heFH) were presented today at the European Society of Cardiology’s Congress 2010 in Stockholm, Sweden. The study met its primary endpoint with a 28 percent reduction in LDL-cholesterol, compared with an increase of 5 percent for placebo (p<0.001). The trial also met all of its secondary and tertiary endpoints. Frequently observed adverse events were injection site reactions, flu-like symptoms and elevations in liver transaminases, as seen in other mipomersen studies.
This double-blind, placebo-controlled phase 3 study was designed to test the efficacy and safety of adding mipomersen to stable lipid-lowering therapy. Patients were randomized 2:1 to receive a 200 mg dose of mipomersen or placebo weekly for 26 weeks. The trial included 124 adult heFH patients at 26 sites in the United States and Canada. All of the patients had pre-existing coronary artery disease and LDL-C levels greater than 100 mg/dL, and were taking a maximally tolerated dose of a statin, as well as additional lipid-lowering drugs in most cases. Prior to study enrollment, 78 percent of patients had previously experienced at least one cardiovascular event and 49 percent had more than one previous cardiovascular event.
Patients treated with mipomersen had an average LDL-C at baseline of 150 mg/dL. These patients had an average LDL-C level of 104 mg/dL at the end of the study. Forty-five percent of the mipomersen-treated patients achieved LDL-C levels of less than 100 mg/dL, a recognized treatment goal for high-risk patients. The reductions observed in the study were in addition to those achieved with the patients’ existing therapeutic regimens.
The trial met all of its secondary and tertiary endpoints. Patients treated with mipomersen experienced a 26 percent reduction in apolipoprotein B compared with a 7 percent increase for placebo; a 19 percent reduction in total cholesterol compared with a 4 percent increase for placebo; and a 25 percent reduction in non-HDL cholesterol compared with a 4 percent increase for placebo (all p<0.001).
Reductions were observed in other atherogenic lipids, including Lp(a) by 21 percent compared with no change for placebo (p<0.001). Apo B and Lp(a) are both generally accepted risk factors for cardiovascular disease. Study results are based on an intent-to-treat analysis (full analysis set).
“Having these data presented is a great milestone for the mipomersen program,” said Paula Soteropoulos, vice president and general manager of Genzyme’s cardiovascular business. “The data underscore our belief that mipomersen has the potential to help those familial hypercholesterolemia patients who are ‘left behind’ by current therapies, and are in need of new treatment options.”
As seen in other mipomersen studies, the most commonly observed adverse events were injection site reactions (93 percent for mipomersen compared with 42 percent for placebo) and flu-like symptoms (49 percent for mipomersen compared with 32 percent for placebo).
All 41 patients treated with placebo completed treatment. Of the 83 patients treated with mipomersen, 73 completed treatment; nine of the discontinuations were related to adverse events, the nature of which was generally similar to previous studies. Reasons for withdrawal from the mipomersen group were: elevations in liver transaminases (3), injection site reactions (2), non-cardiac chest pain (2), injection site reactions and flu-like symptoms (1), and constipation (1).
In this study, elevations in liver transaminases (ALTs) in patients treated with mipomersen were observed that were generally similar in character with those seen in other studies. Six mipomersen-treated patients (7 percent) had persistent ALT elevations above 3X ULN during the treatment period. Persistent is defined as consecutive elevations at least one week apart. As measured by MRI, mipomersen-treated patients had a modest change in liver fat from baseline (median increase of 4.9 percent), compared with the placebo-treated patients (median increase of 0.4 percent). In general, increases in liver transaminases and liver fat appeared to be associated with the greatest reductions of LDL cholesterol. No patients, including those who discontinued the study, had changes in other laboratory tests to indicate hepatic dysfunction, and there were no Hy’s Law cases.
“In all four of the phase 3 studies we have completed, we have seen consistent and robust reductions in LDL cholesterol and other atherogenic lipids that support our plan to initially target homozygous and severe heterozygous familial hypercholesterolemia patients,” said Isis Pharmaceuticals Chairman and CEO Stanley T. Crooke. “We are excited by these positive phase 3 results and look forward to working with Genzyme to bring mipomersen to patients who are in need of a new and novel lipid-lowering agent.”
About Mipomersen
Mipomersen is a first-in-class apo-B synthesis inhibitor currently in late-stage development. It is intended to reduce LDL-C by preventing the formation of atherogenic lipids. It acts by decreasing the production of apo-B, which provides the structural core for all atherogenic lipids, including LDL-C, which carry cholesterol through the bloodstream.
Genzyme’s initial U.S. and E.U. regulatory filings for mipomersen will seek marketing approval for the treatment of patients with homozygous FH (hoFH). These initial filings may also include patients with severe heFH. In the first half of 2011, Genzyme expects to submit the initial U.S. and E.U. filings, and to have made progress toward filing in other major international markets.
Genzyme and Isis have completed all four phase 3 studies planned to support the initial filings. As previously reported, the phase 3 study of mipomersen in hoFH patients met its primary endpoint with 25 percent LDL-C reduction, and results were presented at last year’s American Heart Association meeting. Genzyme and Isis announced top-line results of the phase 3 study in heFH patients in February. The companies last month reported that the phase 3 studies of mipomersen in severe hypercholesterolemia and high-risk patients met their primary endpoints with 36 and 37 percent LDL-C reductions. These four studies will be included in the initial filings. In addition, studies are ongoing and planned to evaluate alternative dosing regimens.
About Familial Hypercholesterolemia
FH is one of the most common genetic disorders, and results in elevated LDL cholesterol levels. FH patients have inherited abnormalities in liver cells that are responsible for clearing LDL-C from the blood. These patients experience a markedly increased risk of premature cardiovascular disease (CVD) and CVD-related death.
There are two forms of FH: homozygous (hoFH), where a defective gene is inherited from both parents, or heterozygous (heFH), where a defective gene is inherited from only one parent. HoFH is a very rare condition estimated to affect approximately one in a million people worldwide. HeFH is a more common form of the disorder, with a prevalence of approximately one in 500.
About Genzyme
One of the world's leading biotechnology companies, Genzyme is dedicated to making a major positive impact on the lives of people with serious diseases. Since 1981, the company has grown from a small start-up to a diversified enterprise with more than 12,000 employees in locations spanning the globe and 2009 revenues of $4.5 billion. In 2010, Genzyme was named to the Fortune 500.
With many established products and services helping patients in 100 countries, Genzyme is a leader in the effort to develop and apply the most advanced technologies in the life sciences. The company's products and services are focused on rare inherited disorders, kidney disease, orthopaedics, cancer, transplant, and immune disease. Genzyme's commitment to innovation continues today with a substantial development program focused on these fields, as well as cardiovascular disease, neurodegenerative diseases, and other areas of unmet medical need.
Genzyme’s press releases and other company information are available at www.genzyme.com and by calling Genzyme’s investor information line at 1-800-905-4369 within the United States or 1-678-999-4572 outside the United States.
About Isis
Isis is exploiting its expertise in RNA to discover and develop novel drugs for its product pipeline and for its partners. The Company has successfully commercialized the world's first antisense drug and has 23 drugs in development. Isis' drug development programs are focused on treating cardiovascular, metabolic, and severe neurodegenerative diseases and cancer. Isis' partners are developing antisense drugs invented by Isis to treat a wide variety of diseases. Isis and Alnylam Pharmaceuticals are joint owners of Regulus Therapeutics Inc., a company focused on the discovery, development and commercialization of microRNA therapeutics. Isis also has made significant innovations beyond human therapeutics resulting in products that other companies, including Abbott, are commercializing. As an innovator in RNA-based drug discovery and development, Isis is the owner or exclusive licensee of approximately 1,600 issued patents worldwide. Additional information about Isis is available at www.isispharm.com.
Genzyme Safe Harbor Statement
This press release contains forward-looking statements regarding Genzyme’s business plans and strategies regarding mipomersen including, without limitation, statements about its potential uses, its safety profile, the expected timing of regulatory filings in the U.S. and E.U., and the studies that are expected to form a basis of the regulatory filings. These statements are subject to risks and uncertainties that could cause actual results to differ materially from those forecasted. These risks and uncertainties include, among others: that regulatory authorities determine additional clinical studies of mipomersen are needed to support a 2011 filing; that Genzyme is unable to continue to support its clinical and other development efforts related to mipomersen; that regulatory authorities determine mipomersen’s safety profile does not support approval for treatment of any or all of the targeted population; the actual efficacy and safety of mipomersen including, without limitation, the effects of elevations in liver transaminases; and the risks and uncertainties described in Genzyme's SEC reports filed under the Securities Exchange Act of 1934, including the factors discussed under the caption "Risk Factors" in Genzyme's Quarterly Report on Form 10-Q for the period ended June 30, 2010. Genzyme cautions investors not to place undue reliance on the forward-looking statements contained in this press release. These statements speak only as of the date of this press release and Genzyme undertakes no obligation to update or revise the statements.
Genzyme® is a registered trademark of Genzyme Corporation. All rights reserved.
Isis Safe Harbor Statement
This press release includes forward-looking statements regarding Isis’ collaboration with Genzyme Corporation, its financial and business development activities, and the development, activity, therapeutic potential and safety of mipomersen in treating patients with high cholesterol. Any statement describing Isis’ goals, expectations, financial or other projections, intentions or beliefs is a forward-looking statement and should be considered an at-risk statement. Such statements are subject to certain risks and uncertainties, particularly those inherent in the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs. Isis’ forward-looking statements also involve assumptions that, if they never materialize or prove correct, could cause its results to differ materially from those expressed or implied by such forward-looking statements. Although Isis’ forward-looking statements reflect the good faith judgment of its management, these statements are based only on facts and factors currently known by Isis. As a result, you are cautioned not to rely on these forward-looking statements. These and other risks concerning Isis’ programs are described in additional detail in Isis’ annual report on Form 10-K for the year ended December 31, 2009 and its most recent quarterly report on Form 10-Q, which are on file with the SEC. Copies of these and other documents are available from the Company.
Isis Pharmaceuticals is a registered trademark of Isis Pharmaceuticals, Inc. Regulus Therapeutics is a trademark of Regulus Therapeutics Inc.
http://ih.advfn.com/p.php?pid=nmona&article=44199033&symbol=N%5EGENZ
SAE
14 years ago
Genzyme Touts Value Of MS Drug, But View May Be Optimistic
Today : Tuesday 31 August 2010
Genzyme Corp. (GENZ), in rejecting an $18.5 billion takeover offer from Sanofi-Aventis SA (SNY SAN.FR), pointed to the bright future of an experimental multiple-sclerosis drug, but those prospects aren't certain and may not be shared by Wall Street.
In a letter to Sanofi Chief Executive Chris Viehbacher on Monday, Genzyme Chief Executive Henri Termeer stressed the "tremendous future upside of our multiple sclerosis drug alemtuzumab," which is the generic name for the MS drug Campath, as among the reasons for Sanofi's offer being too low.
While Campath has shown promise in mid-stage studies, critical late-stage data won't be available until mid-2011, and the drug wouldn't hit the market until late 2012. Furthermore, the market for multiple-sclerosis treatments is getting increasingly crowded, and it could be tough for a new therapy to find significant success, especially if any safety issues arise.
A Genzyme spokesman said Monday that Genzyme expects Campath to immediately capture a quarter of the global MS drug market, which it estimates to be $13 billion in 2012, putting annual sales well above $3 billion. Genzyme had total revenue of $4.5 billion in 2009.
That estimate stands in stark contrast to Wall Street views. Robert Baird analyst Christopher Raymond calculates that Campath's sales will hit $843 million global revenue by 2020, adding just $2 a share to the company's value.
Deutsche Bank estimates peak sales of about $800 million in 2018, while Sanford Bernstein projects 2015 global Campath sales of $675 million in MS.
For a company like Sanofi, with $38 billion in annual revenue and its own oral MS treatment in development, Campath likely isn't a big factor in its acquisition of Genzyme.
But promoting the value of an unproven treatment isn't new. During Roche Holding AG's (RHHBY) pursuit to buy the remaining 44% of Genentech Inc., the target company vigorously argued that data from a study of Avastin's earlier use in colorectal cancer would drastically change the company's value.
In the end, Roche raised its offer and rushed to close the $46.8 billion deal before the data coming out, only to learn of the trial's failure.
Campath could prove to be an important new treatment for MS. In a mid-stage trial, it was much more effective than Rebif, sold by Pfizer Inc. (PFE) and Germany's Merck KGaA (MRK.XE). Campath could be attractive to patients for convenience reasons, because it is given through a yearly infusion as opposed to the daily or weekly injections of many MS therapies.
Like many drugs, Campath is surrounded by questions about its safety that will be closely watched when the late-stage trials are complete, as well as during any regulatory review. Previous testing has showed some patients had side effects including a blood-clotting disorder and thyroid-related problems.
There are also questions about whether patients could be vulnerable to other issues including a rare brain infection called PML, which has been an issue for Tysabri, an MS drug sold by Biogen Idec Inc. (BIIB) and Elan Corp (ELN). Tysabri, which had global sales of $1.1 billion last year, has seen disappointing sales growth and a temporary market withdrawal because of its link to PML.
-By Thomas Gryta, Dow Jones Newswires; 212-416-2169; thomas.gryta@dowjones.com
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MinnieM
14 years ago
Sanofi Closer to Hostile Bid by Making $18.5 Billion Genzyme Offer Public
http://www.bloomberg.com/news/2010-08-29/sanofi-goes-public-with-offer-to-acquire-genzyme-for-18-5-billion-in-cash.html
By Albertina Torsoli and Meg Tirrell - Aug 29, 2010 3:18 PM PT
Sanofi-Aventis SA opened the door to a hostile bid for Genzyme Corp. after going public with an $18.5 billion cash offer for the U.S. biotechnology company and saying it would “consider all alternatives” to complete a deal.
The Paris-based company offered $69 a share in a letter to Genzyme Chief Executive Officer Henri A. Termeer, repeating a proposal made July 29, Sanofi CEO Chris Viehbacher said yesterday. France’s largest drugmaker said it’s making the bid public after “several unsuccessful attempts to engage Genzyme’s management in discussions.”
Sanofi is bidding for Genzyme, the world’s largest maker of medicines for genetic diseases, as products generating about 20 percent of its revenue face generic rivals by 2013. Viehbacher said on a conference call with reporters yesterday that his goal is to negotiate an agreement to buy Genzyme. Acquiring Genzyme would add to Sanofi earnings and fit with the company’s strategy, he said. There is “no assurance” an agreement can be reached between the companies, Sanofi said.
“Now is the right time for Genzyme to consider a transaction that maximizes value for its shareholders,” Viehbacher said. “We remain focused on entering into constructive discussions with Genzyme in order to complete this transaction.”
Bo Piela, a spokesman for Genzyme, declined to comment.
“It could mean they may go hostile,” Mark Schoenebaum, an analyst with ISI Group Inc., said yesterday in a telephone interview. “Basically they’re just going to bypass the board and go straight to shareholders.”
Genzyme, based in Cambridge, Massachusetts, rose 78 cents to $67.62 on Aug. 27 in Nasdaq Stock Market composite trading. Sanofi increased 60 cents, or 1.3 percent, to 45.26 euros in Paris trading.
Offer Premium
The offer represents a 38 percent premium over Genzyme’s “unaffected” share price of $49.86 on July 1, Viehbacher said. On July 2, Bloomberg reported Sanofi had briefed its board of directors on plans for an acquisition of about $20 billion in the U.S.
The bid is a 31 percent premium to the one-month historical average price through July 22, the day before press reports that Sanofi was pursuing Genzyme. This values the U.S. company at 36 times its 2010 earnings per share and 20 times its 2011 earnings per share, according to analyst estimates, Sanofi said in a statement yesterday.
Sanofi’s board supports an offer of up to $70 a share and was unwilling to raise its price at this stage, three people with knowledge of the matter said last week. They asked not to be identified as the talks are private.
‘Extremely Disciplined’
The French drugmaker will remain “extremely disciplined” on acquisitions, Viehbacher told reporters yesterday.
The offer values Genzyme at about 35 times the $1.96 2010 earnings per share average of analysts surveyed by Bloomberg. Because the value of even some large biotech companies lies in drugs that haven’t produced sales or earnings yet, earnings multiples in such acquisitions have varied widely.
Genentech Inc. got 32 times earnings when Roche Holding AG bought the shares of the company it didn’t already own in 2009, while MedImmune Inc. got 91 times from AstraZeneca Plc in 2007 and Immunex Corp. got 95 times earnings in its sale to Amgen Inc. in 2002, according to data compiled by Bloomberg.
“We have an extremely compelling offer on the table,” Viehbacher said during the conference call. “Beyond that it’s difficult to speculate on the next course of action,” he said, adding that Sanofi will take “one step at a time” and that it was too soon to comment on the possibility of a higher offer.
‘Out of the Bushes’
The public offer means “management will have no choice but to come out of the bushes and talk to them,” said Karl-Heinz Koch, an analyst who covers Sanofi at Helvea SA in Zurich, in a telephone interview yesterday.
“We are disappointed that you rejected our proposal on August 11 without discussing its substance with us,” Viehbacher wrote in the letter to Termeer. “Our financial advisers finally met briefly on August 24, but the meeting simply served as further confirmation that as throughout you remain unwilling to have constructive discussions.”
Genzyme’s stock sank earlier this year as low as $47.16, down 43 percent from a 2008 high of $83.25, as the company faced manufacturing problems that caused shortages of its best-selling drugs. The company agreed in May to pay a $175 million penalty after the U.S. Food and Drug Administration found quality deficiencies at its Allston Landing facility.
FDA Penalties
Genzyme may face added fines of about $130 million if it fails to meet FDA deadlines for moving bottling and finishing to other facilities, as well as daily fees of $15,000 for each drug made in Allston if the company misses any of its remediation goals, said Michael Leuchten, a Barclays Capital analyst.
“Sanofi-Aventis’ global reach and significant resources would allow Genzyme to accelerate investment in new treatments, enhance penetration in existing markets and expand further into emerging markets,” the French company said in the statement.
Viehbacher said the offer for Genzyme is a “strong” one, considering the “challenges” the U.S. company is facing.
Genzyme’s products are less likely to face generic competitors because they’re made from living cells and are harder to copy than traditional pills made from chemical compounds. The therapies are designated as orphan drugs by the FDA because they are for diseases without other treatment options, giving them added patent protection.
‘Compelling Offer’
Sanofi has spent about $17 billion on acquisitions since Viehbacher joined the company in 2008.
Sven Borho, a partner with OrbiMed Advisors in New York, said on Aug. 4 that he would require a minimum bid of $75 a share to sell. OrbiMed holds about 2.5 million Genzyme shares.
“Sanofi is losing revenue and needs to address its problems,” Borho said in a telephone interview then. “Don’t come through Genzyme and try to get a discount.” Borho didn’t immediately return calls placed to his office after normal business hours yesterday.
“If Sanofi goes hostile, I don’t believe a price under $75 will get it done,” said Schoenebaum of ISI. “The majority of shareholders probably will hold out until Sanofi offers something closer to $80 than $70.”
Sanofi Chief Financial Officer Jerome Contamine said on the conference call that the company has secured financing for the transaction from JPMorgan Chase & Co., BNP Paribas SA and Societe Generale SA. Evercore Partners Inc. and JPMorgan are its lead financial advisers, according to the statement. Weil, Gotshal & Manges LLP is acting as legal counsel, the company said. Viehbacher declined to comment on details of the financing.
It’s unlikely another buyer will approach Genzyme, meaning the takeover process could be drawn out, according to Schoenebaum.
“No one has a gun to Sanofi’s head,” he said.
(Sanofi will hold a call for analysts and investors today at 2:30 p.m. Paris time to discuss the proposal. Callers in France should dial +33-1-72-00-13-68. U.S. callers should dial +1-866-907-5923. U.K. callers should dial +44-203-367-9453.)
To contact the reporters for this story: Albertina Torsoli at atorsoli@bloomberg.net; Meg Tirrell in New York at mtirrell@bloomberg.net
SAE
14 years ago
UPDATE: Genzyme: US Cerezyme Dosing Returns To Normal In Sept
Today : Friday 27 August 2010
Genzyme Corp. (GENZ) will return U.S. patients using its top-selling Cerezyme to normal dosing in September, as well as increase dosing for Fabrazyme patients, both moves coming a month earlier than expected amid a long shortage of the rare disease treatments.
Patients using Cerezyme, used to treat the rare genetic disorder Gaucher's disease, and Fabry disease drug Fabrazyme, generally haven't been able to use the drugs normally since last year because of problems at an Allston, Mass., production facility, the sole source of the products.
Patients affected by both diseases lack specific enzymes - which the drugs replace - that break down certain types of fats, causing them to build up in the body and leading to major problems including pain, skeletal complications, organ failure and death.
In the U.S., Cerezyme patients will be returning to normal dosing in September, and the company will start adding new patients from a waiting list during the month. That list includes both patients that have stopped using the treatment, and those that haven't been treated before.
Across the world, patient doses of the drug will increase in September in most markets and will return to normal in the fourth quarter, the company said.
Although it is confident in continuing the supply of Cerezyme, Genzyme will update its supply plan again in late September.
For Fabrazyme, production has been plagued by efficiency problems since the restart of the Allston plant, but the company said U.S. patients will also increase dosing in September followed by the rest of the world in the fourth quarter.
"We are not as positive as we are about Cerezyme, but we are continuing to make progress," said John Butler, president of Genzyme's personalized genetic health business on Thursday.
Fabrazyme patients in the U.S. will receive a dose a month for September and October. They had received a dose every other month for the past few months, the company said.
For both drugs, normal dosing generally means getting the drug twice a month. Many Cerezyme patients have been getting the drug once a month during the shortage. Genzyme continues to have no projection for when Fabrazyme patient can return to normal dosing.
Genzyme had previously said it would return Cerezyme patients to normal dosing and increase dosing in Fabrazyme in the fourth quarter.
The news comes as Genzyme has been under siege from activist investors in recent months, and is reportedly in takeover talks with France's Sanofi-Aventis SA (SNY).
The Allston plant has been plagued by problems, including numerous failed regulatory inspections and a temporary shutdown last year due to contamination, something that has caused product shortages and hurt Genzyme's earnings. The company recently extended the timeline for fixing the issues by a year, meaning regulatory oversight of the plant could last as many as nine years.
Cerezyme sales dropped 34% last year to $793 million due to the shortage, while Fabrazyme sales dropped 13% to $494 million. The company had total revenue of $4.5 billion.
The problems have allowed the entrance of competitors to the drugs. Shire PLC (SHPGY SHP.LN) makes Gaucher's treatment Vpriv, which was approved in the U.S. in February and in Europe on Thursday. It already sells Fabry disease drug Replagal in Europe and plans to file for U.S. approval.
Protalix BioTherapeutics Inc. (PLX) is developing a Gaucher's disease treatment with Pfizer Inc. (PFE) that is under Food and Drug Administration review.
Because of the shortages, the FDA allowed all the drugs to be used under a special protocol last year, despite not being approved for marketing.
Although Genzyme's Allston facility is fully operational for production purposes, Butler expressed confidence in maintaining patients on the increased dosing, but warned the situation remains fragile.
"We are working without inventory, so any minor disruption could cause an issue for us," Butler said.
Shares of Genzyme recently traded down 50 cents to $67.08.
-By Thomas Gryta, Dow Jones Newswires; 212-416-2169; thomas.gryta@dowjones.com
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SAE
14 years ago
Two-Year Data from Phase 2 Trial of Genzyme’s Eliglustat Tartrate for Gaucher Disease To Be Published in the Journal Blood
Monday 23 August 2010
Genzyme Corporation (NASDAQ: GENZ) announced today that the two-year follow-up results from the phase 2 clinical trial of its investigational therapy known as eliglustat tartrate have been accepted for publication in the journal Blood. The results have been pre-published on the journal’s website and are available to subscribers.
Eliglustat tartrate, a capsule taken orally, is being developed to provide a convenient treatment alternative for adult patients with Gaucher disease type 1, and to offer a broader range of treatment options for patients and physicians to achieve individual therapeutic goals. Current treatments, including Genzyme’s Cerezyme® (imiglucerase for injection), the standard of care for patients with Gaucher disease type 1, are administered through intravenous infusions.
Genzyme reported last year that the 52-week phase 2 trial of eliglustat tartrate had met its primary composite endpoint: a clinically meaningful response in at least two of three endpoints (improvements in spleen size, hemoglobin and platelet levels) in individual patients. The two-year data to be published in Blood indicate continued improvements across all endpoints. After two years, most patients (85%) had met at least three of the four hematologic and visceral therapeutic goals established for enzyme replacement therapy. These data also suggest that eliglustat tartrate may positively impact two indicators of bone disease, bone mineral density and the presence of dark marrow.
The most common adverse events reported in greater than 10 percent of patients included viral infections (six patients), urinary tract infections, increased blood pressure, and abdominal pain (three patients each). Eight drug-related adverse events, including one serious event, were reported in six patients. All were mild in severity.
These two-year results were presented at the Lysosomal Disease Network WORLD Symposium earlier this year.
Phase 3 Program
Genzyme is currently enrolling patients in three global, multi-center, phase 3 trials of eliglustat tartrate. Combined, more than 450 patients are expected to participate, making this the largest clinical program ever focused on Gaucher disease. Over 50 sites in more than 25 countries are currently participating, with additional centers planned.
The first phase 3 trial, ENCORE, is a randomized, open-label study for adult patients with Gaucher disease type 1, designed to compare eliglustat tartrate to Cerezyme. Adult patients who have previously received enzyme replacement therapy for at least three years and have reached their therapeutic goals may qualify for this trial. The second trial, ENGAGE, is a randomized, double-blind, placebo-controlled study for patients with a confirmed diagnosis of Gaucher disease type 1. Patients who have not received enzyme replacement therapy within 9 months or substrate reduction therapy within 6 months of participation may qualify for this study. Genzyme recently launched a third trial, known as EDGE, to compare once-daily dosing of eliglustat tartrate with twice-daily dosing.
“We remain very enthusiastic about the potential of eliglustat tartrate,” said Genzyme’s President of Personalized Genetic Health, John Butler. “Through this robust phase 3 program, we look forward to increasing our understanding of the compound as we work to offer patients and physicians more treatment choices to help optimize the management of Gaucher disease.”
Complete results from the one-year analysis period for eliglustat tartrate were previously published in Blood. The study and accompanying commentary can be found here.
To learn more about enrolling in the Phase 3 trials, contact Genzyme Medical Information at medinfo@genzyme.com or 1-800-745-4447. More information can also be found at www.clinicaltrials.gov.
About Gaucher disease
Gaucher disease is an inherited condition affecting fewer than 10,000 people worldwide. People with Gaucher disease do not have enough of an enzyme, ß-glucosidase (glucocerebrosidase) that breaks down a certain type of fat molecule. As a result, lipid engorged cells (called Gaucher cells) amass in different parts of the body, primarily the spleen, liver and bone marrow. Accumulation of Gaucher cells may cause spleen and liver enlargement, anemia, excessive bleeding and bruising, bone disease and a number of other signs and symptoms. The most common form of Gaucher disease, type 1, does not affect the brain or nervous system.
About eliglustat tartrate
Eliglustat tartrate, a novel glucosylceramide analog given orally, is designed to partially inhibit the enzyme glucosylceramide synthase, which results in reduced production of glucosylceramide. Glucosylceramide is the substance that builds up in the cells and tissues of people with Gaucher disease. In preclinical studies, the molecule, developed with James A. Shayman, MD, from the University of Michigan, has shown high potency and specificity. Based on its mechanism of action, which is independent of genotype, eliglustat tartrate may be a potential therapy for all patients with Gaucher disease type 1. Initiation of the Phase 2 and 3 studies of eliglustat tartrate in Gaucher disease followed completion of an extensive pre-clinical research effort and a Phase 1 program that involved more than 120 subjects in three separate studies. The most common adverse events (AEs) by two years included viral infections, urinary tract infections, increased blood pressure and abdominal pain.
Cerezyme important safety information
Approximately 15 percent of patients have developed IgG antibodies. These patients have a higher risk of hypersensitivity reaction. Therefore periodic monitoring is suggested; caution should be exercised in patients with antibodies or prior symptoms of hypersensitivity. Symptoms suggestive of hypersensitivity occurred in 6.6 percent of patients, and include anaphylactoid reaction, pruritus, flushing, urticaria, angioedema, chest discomfort, dyspnea, coughing, cyanosis and hypotension. Reactions related to Cerezyme administration have been reported in less than 15 percent of patients. Each of the following events occurred in less than two percent of the total patient population. Reported adverse events include nausea, vomiting, abdominal pain, diarrhea, rash, fatigue, headache, fever, dizziness, chills, backache and tachycardia. Adverse events associated with the route of administration include discomfort, pruritus, burning, swelling or sterile abscess at the site of venipuncture. For full prescribing information, please visit www.genzyme.com.
About Genzyme
One of the world's leading biotechnology companies, Genzyme is dedicated to making a major positive impact on the lives of people with serious diseases. Since 1981, the company has grown from a small start-up to a diversified enterprise with more than 12,000 employees in locations spanning the globe and 2009 revenues of $4.5 billion. In 2010, Genzyme was named to the Fortune 500.
With many established products and services helping patients in 100 countries, Genzyme is a leader in the effort to develop and apply the most advanced technologies in the life sciences. The company's products and services are focused on rare inherited disorders, kidney disease, orthopaedics, cancer, transplant, and immune disease. Genzyme's commitment to innovation continues today with a substantial development program focused on these fields, as well as cardiovascular disease, neurodegenerative diseases, and other areas of unmet medical need.
Genzyme’s press releases and other company information are available at www.genzyme.com and by calling Genzyme’s investor information line at 1-800-905-4369 within the United States or 1-678-999-4572 outside the United States.
Genzyme® and Cerezyme® are registered trademarks of Genzyme Corporation. All rights reserved.
This press release contains forward looking statements regarding Genzyme’s investigational therapy eliglustat tartrate including: that eliglustat tartrate will offer a broad range of treatment options to physicians and convenience to patients and that eliglustat tartrate could have a significant impact on bone mineral density and make a positive impact on patients’ lives. These forward looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those forecasted. These risks and uncertainties include: that regulatory approval of eliglustat tartrate will be delayed or limited either in the United States or elsewhere, that eliglustat tartrate will not be available for patients’ convenience and will not provide additional treatment options to physicians or patients; that eliglustat tartrate will not have a positive effect on bone mineral density or otherwise on bone disease and will not impact patients lives; and the risks and uncertainties described in reports filed by Genzyme with the Securities and Exchange Commission under the Securities Exchange Act of 1934, as amended, including without limitation the information under the heading "Risk Factors" in Genzyme’s Quarterly Report on Form 10-Q for the quarter ending June 30, 2010. Genzyme cautions investors not to place substantial reliance on the forward-looking statements contained in this press release. These statements speak only as of the date of this press release, and Genzyme undertakes no obligation to update or revise these statements.
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SAE
14 years ago
UPDATE: Genzyme's Troubled Mass. Plant To Take Longer To Fix
Genzyme (NASDAQ:GENZ)
Historical Stock Chart [at link below]Hi KarinCA! Thanks for helping to keep this board updated...Stockinvestor. Do you still like Apple?
1 Month : July 2010 to August 2010
Genzyme Corp. (GENZ) expects its plan to fix its troubled Allston, Mass., production facility to take up to four years, longer than the drug maker previously projected.
The lengthened timeline means regulatory oversight of the plant could last as many as nine years and suggests there's no quick fix to the problems that have led to shortages of unique treatments for certain genetic disorders. The news comes as Genzyme has been under siege from activist investors in recent months, and is reportedly in takeover talks with France's Sanofi-Aventis SA (SNY).
The Allston plant has been plagued by problems, including numerous failed regulatory inspections and a temporary shutdown last year from contamination, something that has caused product shortages and hurt Genzyme's earnings.
Ron Branning, Genzyme's senior vice president for global quality, who joined the company in January to help with the manufacturing issues, said the timeline change came after reviewing the remediation plans in the wake of May's consent decree.
The company disclosed the "revised" timeline of three-to-four years in its 396-page quarterly report filed with the Securities and Exchange Commission. In May, Genzyme estimated the time frame as two-to-three years.
"I'm telling everyone that we aren't going to rush through the planning," he said.
He wants to make sure that the company has enough time to correct problems or pursue questions that arise from the process. He noted that the three-to four-year process won't actually begin until the plan is submitted to the FDA in the fourth quarter.
Notably, Branning said the timeframe shift was influenced by having enough time to meet deadlines included in the remediation plan, which could lead to fines of $15,000 a day per affected drug if they are missed. An efficient plan could shorten the time needed, Branning said.
"If you look at approximately three years for most of the things that are going on, that is the best way of thinking," he said.
The new timeline doesn't effect Genzyme's other plans, including rectifying shortages of its top-selling products, and it won't have a financial impact. The company's manufacturing problems have hurt patients, who were forced to skip or reduce their doses due to lack of supply.
The company still plans to increase shipments of Cerezyme this month with patients returning to normal dosing in the fourth quarter. Genzyme is improving the production efficiency for Fabrazyme, a problem since it restarted the Allston plant, and expects to increase shipments in the fourth quarter. It has no projection for returning patients to normal dosing.
Throughout the plant's numerous setbacks, Genzyme's management has been criticized by Wall Street as being too optimistic about a regulatory situation that has lingered for years. For example, an FDA inspection of the plant last fall produced 49 different issues, even though the visit was expected in the wake of multiple failed inspections dating back to 2008.
"Any time you deal with the FDA...I think you always have to take the most conservative stance possible, and I don't think they have done that historically," Piper Jaffray analyst Ian Somaiya said.
Genzyme shares, up more than 45% from their May low on take-over speculation, closed down 1.5% to $66.82 on Wednesday.
In deciding to pursue an acquisition of Genzyme, Sanofi knew that the biotech company's prospects for turning around its operations aren't guaranteed and factored that risk into its decision to go after the company, people familiar with the matter said Wednesday.
Therefore, the latest timeline shift shouldn't have a large influence on the take-over talks unless it causes further drug shortages or produces other major problems.
The company has signed a consent decree, essentially a negotiated injunction, with the FDA that calls for outside oversight at Allston and a $175 million fine. After Genzyme's remediation plan is complete, the plant will still be subjected to five years of oversight from an outside auditor at the site to ensure continued compliance.
Under the consent decree, the third party overseer, a firm called The Quantic Group, is currently conducting an inspection of the Allston plant and will prepare a report. Those findings, which Branning said are likely to be consistent with regulators' prior findings, will be incorporated into the remediation plan to be submitted to the FDA.
-By Thomas Gryta, Dow Jones Newswires; 212-416-2169; thomas.gryta@dowjones.com
(Jonathan D. Rockoff and Gina Chon contributed to this report)
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MinnieM
14 years ago
Genzyme and Isis Report Results of Two Phase 3 Trials of Mipomersen
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Genzyme Corp. (NASDAQ: GENZ) and Isis Pharmaceuticals Inc. (NASDAQ: ISIS) today announced results of two phase 3 studies of mipomersen in patients who had high cholesterol levels while on maximally tolerated lipid-lowering therapy. In the study of patients with severe hypercholesterolemia, mipomersen reduced LDL-C, the primary endpoint, by 36 percent compared with a 13 percent increase for placebo. In the study of patients with high cholesterol at high cardiovascular risk, mipomersen reduced LDL-C by 37 percent compared with a 5 percent reduction for placebo. Both studies met all of their secondary endpoints. Frequently observed adverse events were injection site reactions, flu-like symptoms and elevations in liver transaminases, as seen in previous studies.
With these studies, the companies have completed the four phase 3 studies that are planned to be included in the initial U.S. and E.U. regulatory filings for mipomersen. These filings, expected in the first half of 2011, will seek approval for the treatment of patients with homozygous familial hypercholesterolemia (FH), and may also include patients with severe hypercholesterolemia. The two previous phase 3 studies of mipomersen, which focused on patients with homozygous and heterozygous FH, also met their primary and secondary endpoints.
“We are pleased with the robust efficacy of mipomersen across all four phase 3 trials. These data, along with the emerging safety profile, support our focused approach on patients at highest cardiovascular risk who are in the greatest need of new treatments,” said Genzyme Senior Vice President John Butler. “With completion of these studies, we remain on-track with our plans for mipomersen.”
Phase 3 Study in Patients with Severe Hypercholesterolemia
This double-blind, placebo-controlled trial included 58 patients with severe hypercholesterolemia who were already taking maximally tolerated lipid-lowering medications. Severe hypercholesterolemia patients were defined as those who have LDL-C levels = 200 mg/dL with baseline cardiovascular disease (CVD) or LDL-C levels = 300 mg/dL without CVD. Patients were randomized 2:1 to receive a 200 mg dose of mipomersen or placebo weekly for 26 weeks. This study was conducted at 26 sites in North America, Europe and South Africa.
Patients treated with mipomersen had an average LDL-C at baseline of 276 mg/dL. At the end of the trial, these patients had an average LDL-C level of 175 mg/dL, representing an average LDL-C reduction of 101 mg/dL (36 percent). The reductions observed in the study were in addition to those achieved with the patients’ existing maximally tolerated lipid-lowering regimens. The trial also met each of its three secondary endpoints with statistically significant reductions in apo-B, non-HDL-cholesterol and total cholesterol. Study results are based on an intent-to-treat analysis (full analysis set). Detailed results will be submitted for presentation at a medical meeting.
Of the 39 patients treated with mipomersen, 27 completed treatment; of the 19 patients treated with placebo, 18 completed treatment. Eight of the discontinuations in the mipomersen group were reported as being related to adverse events, the nature of which was generally similar to previous studies. The placebo discontinuation was reported as being related to an adverse event. There was one death in the study due to acute coronary syndrome in a patient treated with mipomersen that was reported as unrelated to treatment.
Elevations in liver transaminases (ALTs) in patients treated with mipomersen were observed that were generally similar in character with those seen in other studies. In this study, 15 percent of patients had persistent ALT elevations above 3X ULN (three times the upper limit of normal) during the treatment period. Persistent is defined as consecutive elevations at least one week apart. No patients had changes in laboratory tests indicative of clinically significant hepatic dysfunction, and there were no Hy’s Law cases.
“There are patients, such as those with familial hypercholesterolemia, who are on maximally tolerated doses of currently available medications and still are very far from appropriate target goals,” said James A. Underberg, M.D., of the New York University Center for Cardiovascular Disease Prevention. “For these high risk patients, there exists a tremendous need for additional lipid lowering therapies.”
Phase 3 Study in Hypercholesterolemic Patients at High Risk of Developing Coronary Heart Disease
This double-blind, placebo-controlled trial included 158 patients with hypercholesterolemia (LDL-C = 100 mg/dL) and at high risk of developing coronary heart disease (CHD) who were taking a maximally tolerated dose of a statin. Patients were randomized 2:1 to receive a 200 mg dose of mipomersen or placebo weekly for 26 weeks. This study was conducted at 43 sites in the United States and Canada. This was the first study of mipomersen designed to evaluate patients with diabetes. More than 50 percent of patients in the study had type 2 diabetes.
Patients treated with mipomersen had an average LDL-C at baseline of 123 mg/dL. At the end of the study, these patients had an average LDL-C level of 75 mg/dL, representing an average LDL-C reduction of 48 mg/dL (37 percent). Half of the mipomersen-treated patients achieved LDL-C levels of less than 70 mg/dL, a recognized treatment goal for high-risk patients. The reductions observed in the study were in addition to those achieved with the patients’ existing maximally tolerated statin regimens. The trial also met each of its three secondary endpoints with statistically significant reductions in apo-B, non-HDL-cholesterol and total cholesterol. Study results are based on an intent-to-treat analysis (full analysis set). Detailed results will be submitted for presentation at a medical meeting.
Of the 105 patients treated with mipomersen, 60 completed treatment; of the 53 patients treated with placebo, 44 completed treatment. Twenty-six of the discontinuations in the mipomersen group were reported as being related to adverse events, the nature of which was generally similar to previous studies. Two of the discontinuations in the placebo group were reported as being related to adverse events. There was one death in the study due to acute myocardial infarction in a patient treated with placebo.
Elevations in ALTs in patients treated with mipomersen were observed that were generally similar in character with those seen in other studies. In this study, 10 percent of patients had persistent ALT elevations above 3X ULN during the treatment period. Persistent is defined as consecutive elevations at least one week apart. In many cases, these elevations were associated with increased hepatic fat content, as measured by MRI. No patients had changes in laboratory tests indicative of clinically significant hepatic dysfunction, and there were no Hy’s Law cases.
“The completion of these phase 3 studies is a significant milestone for the mipomersen program, for antisense technology and for patients in need,” said Isis Pharmaceuticals Chairman and CEO Stanley T. Crooke. “Mipomersen’s lipid-lowering activity demonstrates the value antisense drugs can bring to patients. Our robust pipeline is evidence of the efficiency of our technology and the potential value we can create.”
Late-Stage Development Plan
Genzyme’s initial U.S. and E.U. regulatory filings for mipomersen will seek marketing approval for the treatment of patients with the genetic disease homozygous FH (hoFH). These initial filings may also include patients with severe hypercholesterolemia. In the first half of 2011, Genzyme expects to submit the initial U.S. and E.U. filings, and to have made progress toward filing in other major international markets.
As previously reported, the phase 3 study of mipomersen in hoFH patients met its primary endpoint with 25 percent LDL-C reduction, and results were presented at last year’s American Heart Association meeting. Genzyme and Isis in February reported that the phase 3 study of mipomersen in heFH met its primary endpoint with a 28 percent LDL-C reduction, and data will be presented at the European Society of Cardiology meeting this month. In addition, studies are ongoing and planned to evaluate alternative dosing regimens.
About Mipomersen
Mipomersen is a first-in-class apo-B synthesis inhibitor currently in late-stage development. It is intended to reduce LDL-C by preventing the formation of atherogenic lipids. It acts by decreasing the production of apo-B, which provides the structural core for all atherogenic lipids, including LDL-C, which carry cholesterol through the bloodstream.
About Genzyme
One of the world's leading biotechnology companies, Genzyme is dedicated to making a major positive impact on the lives of people with serious diseases. Since 1981, the company has grown from a small start-up to a diversified enterprise with more than 12,000 employees in locations spanning the globe and 2009 revenues of $4.5 billion. In 2010, Genzyme was named to the Fortune 500.
With many established products and services helping patients in 100 countries, Genzyme is a leader in the effort to develop and apply the most advanced technologies in the life sciences. The company's products and services are focused on rare inherited disorders, kidney disease, orthopaedics, cancer, transplant, and immune disease. Genzyme's commitment to innovation continues today with a substantial development program focused on these fields, as well as cardiovascular disease, neurodegenerative diseases, and other areas of unmet medical need.
Genzyme’s press releases and other company information are available at www.genzyme.com and by calling Genzyme’s investor information line at 1-800-905-4369 within the United States or 1-678-999-4572 outside the United States.
About Isis
Isis is exploiting its expertise in RNA to discover and develop novel drugs for its product pipeline and for its partners. The Company has successfully commercialized the world's first antisense drug and has 23 drugs in development. Isis' drug development programs are focused on treating cardiovascular, metabolic, and severe neurodegenerative diseases and cancer. Isis' partners are developing antisense drugs invented by Isis to treat a wide variety of diseases. Isis and Alnylam Pharmaceuticals are joint owners of Regulus Therapeutics Inc., a company focused on the discovery, development and commercialization of microRNA therapeutics. Isis also has made significant innovations beyond human therapeutics resulting in products that other companies, including Abbott, are commercializing. As an innovator in RNA-based drug discovery and development, Isis is the owner or exclusive licensee of approximately 1,600 issued patents worldwide. Additional information about Isis is available at www.isispharm.com
Genzyme Safe Harbor Statement
This press release contains forward-looking statements regarding Genzyme’s business plans and strategies regarding mipomersen including, without limitation, statements about its potential uses, the expected timing of regulatory filings in the U.S. and E.U., and the studies that are expected to form a basis of the regulatory filings. These statements are subject to risks and uncertainties that could cause actual results to differ materially from those forecasted. These risks and uncertainties include, among others: that regulatory authorities determine additional clinical studies of mipomersen are needed to support a 2011 filing; that Genzyme is unable to continue to support its clinical and other development efforts related to mipomersen; that regulatory authorities determine mipomersen’s safety profile does not support approval for treatment of any or all of the targeted population; and the risks and uncertainties described in Genzyme's SEC reports filed under the Securities Exchange Act of 1934, including the factors discussed under the caption "Risk Factors" in Genzyme's Quarterly Report on Form 10-Q/A for the period ended March 31, 2010. Genzyme cautions investors not to place undue reliance on the forward-looking statements contained in this press release. These statements speak only as of the date of this press release and Genzyme undertakes no obligation to update or revise the statements.
Genzyme® is a registered trademark of Genzyme Corporation. All rights reserved.
Isis Safe Harbor Statement
This press release includes forward-looking statements regarding Isis’ collaboration with Genzyme Corporation, its financial and business development activities, and the development, activity, therapeutic potential and safety of mipomersen in treating patients with high cholesterol. Any statement describing Isis’ goals, expectations, financial or other projections, intentions or beliefs is a forward-looking statement and should be considered an at-risk statement. Such statements are subject to certain risks and uncertainties, particularly those inherent in the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs. Isis’ forward-looking statements also involve assumptions that, if they never materialize or prove correct, could cause its results to differ materially from those expressed or implied by such forward-looking statements. Although Isis’ forward-looking statements reflect the good faith judgment of its management, these statements are based only on facts and factors currently known by Isis. As a result, you are cautioned not to rely on these forward-looking statements. These and other risks concerning Isis’ programs are described in additional detail in Isis’ annual report on Form 10-K for the year ended December 31, 2009 and its most recent quarterly report on Form 10-Q, which are on file with the SEC. Copies of these and other documents are available from the Company.
Isis Pharmaceuticals is a registered trademark of Isis Pharmaceuticals, Inc. Regulus Therapeutics is a trademark of Regulus Therapeutics Inc.
Conference Call Information
Genzyme and Isis will host a conference call today at 8:30 a.m. Eastern. To participate in the call, please dial 1-517-308-9370 and refer to pass code “Genzyme.” This call will also be webcast live on the investor events section of www.genzyme.com and on www.isispharm.com. A replay of this call will be available by dialing 1-203-369-0784. Replays of the call and the webcast will be available until midnight on August 12, 2010.
SAE
14 years ago
Sanofi Will Be Concerned About Overpaying for Genzyme
The initially hazy Sanofi-Aventis rumors are gradually turning into something more concrete. A few weeks after reports emerged claiming senior management had been briefed about the possibility of a $20bn US deal, the name Genzyme (GENZ) has entered the frame (Rumoured $20bn Sanofi-Aventis swoop could be about diversification, July 2, 2010).
Confirmation that Sanofi is keen to do a big deal is not really surprising; the company is facing the loss of several blockbusters in the coming years, neatly demonstrated on Friday by news that generic Lovenox has finally been approved in the US. That Genzyme might fall to a bid in this period of weakness is also not much of a revelation; if any predator has designs on the beleaguered US biotech, now would be the time to make a move, when there is ammunition available to argue the price down. What would be surprising is if a bidding war commences.
Reasons for caution
Although Genzyme is without doubt a potentially valuable asset, there are reasons why potential bidders would be cautious (Genzyme moves on but faces uncertain future, May 25, 2010).
For one, the company is operating under a consent decree from the FDA, which will be monitoring the company for the next eight years as it implements manufacturing improvements. Any slip from the timetable set out by the regulator will result in hefty fines. On top of this, the competitive landscape has significantly worsened as rivals gained entrance to Genzyme’s previous monopolies.
However, although this all makes the company tricky to value, it is still in a very strong position in a couple of highly profitable areas of medicine. If a predator can extract the right price, a deal could work.
No doubt there are a couple of big pharma chief executives working out the amount at which a takeover would look tempting. As well as Sanofi-Aventis, as reported by the Wall Street Journal last Friday, GlaxoSmithKline (GSK) is said to have made informal overtures, the paper claimed Monday.
Johnson & Johnson (JNJ) is probably the only other major that might realistically consider such a deal; others are already busy integrating mega mergers or probably not strong enough to pull it off. J&J certainly has the financial capacity, whether it has the inclination is less clear.
Over-paying
Despite the seeming openness to a big deal, Genzyme’s problems means Sanofi, or any other interested party, will be very concerned about overpaying. As EP Vantage discussed a few months ago, Genzyme’s low relative valuation on a number of measures was deserved, and time was needed to see how the company would deliver on its recovery plan (Genzyme re-rating will require more evidence of recovery, May 26, 2010).
Shares in the biotech have of course surged on this speculation, breaching $66 in early trade Monday for the first time in 17 months, up from $54 before the takeover rumors emerged. However, the stock had breached $80 a couple of times in the heady days of 2008.
Despite having the vociferous Carl Icahn on the shareholder register and on the board by proxy, Genzyme is unlikely to sell for anything close to $80 a share.
With Genzyme’s long serving chief executive, Henri Termeer, about to retire having held the reins since 1983 and multiple calls for his resignation in the wake of the manufacturing problems, now looks like a perfect time to head to the negotiating table.
Impetus
Even if Glaxo and J&J are interested, Sanofi-Aventis would certainly seem to have the most reason to chase a Genzyme takeover of the three, with multiple patent expiries approaching. This includes the $3bn Taxotere franchise later this year and next year the $1.7bn Avapro brand and of course Plavix, which generated sales of $3.3bn in 2009.
The company’s exposure to the anti-thrombotics space is revealed in another analysis by EP Vantage (Therapeutic focus - Anti-thrombotics face a period of change, July 26, 2010).
The timing of generic Lovenox was never clear and confirmation that it is underway will certainly hurt. This news was no doubt the reason for the 4% decline in Sanofi’s share price on Friday, rather than any inkling of the Genzyme rumors in the market.
Sanofi has already moved to lower earnings guidance this year, and financial analysts have followed. UBS calculates that US Lovenox sales accounted for 6% of the company’s sales over the last 12 months and 10% of earnings per share. RBS meanwhile has trimmed 8% from its earnings forecasts over the next six years.
The company’s shares held fairly steady Monday, at €45.22, despite talk of an acquisition that could breach $20bn. Still, this is only a whisker away from a 12-month low. With the challenges facing Sanofi which UBS analysts believe could, at worst, provide a case-study for deteriorating pharma profit margins, there is clearly appetite for a big deal among the upper echelons of the company.
The price that emerges will reveal exactly how hungry they are.
About the author: EP Vantage
http://seekingalpha.com/article/216599-sanofi-will-be-concerned-about-overpaying-for-genzyme
SAE
14 years ago
Genzyme Reports Financial Results for the Second Quarter of 2010
Genzyme (NASDAQ:GENZ)
Genzyme Corp. (NASDAQ: GENZ) today reported that second-quarter revenue was $1.08 billion, compared with $1.23 billion in the same period last year, reflecting limited shipments of Cerezyme® (imiglucerase for injection) and Fabrazyme® (agalsidase beta) due to product supply constraints in 2010. The company expects to be able to increase shipments of Cerezyme and Fabrazyme during the second half of the year.
GAAP net income was $23,000, or $0.00 per diluted share, compared with net income of $187.6 million, or $0.68 per diluted share, in the second quarter of 2009. Non-GAAP net income was $47.6 million, or $0.18 per diluted share, compared with $226.6 million, or $0.82 per diluted share, in the same period last year.
GAAP and non-GAAP figures include pre-tax manufacturing write-offs of $21.9 million, or $0.06 per diluted share, primarily for material that had to be discarded following the interruption in operations at the Allston facility late in the first quarter and for costs associated with the temporary shutdown of the company’s Haverhill, U.K., facility in December 2009. These figures also include a pre-tax write-down of $32.3 million, or $0.08 per diluted share, for the company’s 2008 equity investment in Isis Pharmaceuticals, reflecting the extent to which the share price paid exceeds the current market value. Non-GAAP net income excludes stock compensation expenses and costs associated with the acquisition of oncology products from Bayer.
“This was a difficult quarter as reflected in our financial results, but based on the progress we’ve made with our recovery efforts, the outlook for the second half of 2010 is promising,” said Henri A. Termeer, Genzyme’s chairman and chief executive officer. “We are encouraged by the improvements in Cerezyme and Fabrazyme manufacturing. We expect that increasing sales of these products combined with reductions in our operating costs will produce an increase in earnings during the second half of the year.”
During the second quarter, Genzyme continued to make progress in transforming its manufacturing operations, maximizing the potential of its product portfolio, and advancing key pipeline programs to ensure sustainable long-term growth. Major operational milestones included FDA approval of Lumizyme™ (alglucosidase alfa) for late-onset Pompe disease patients in the United States; progress in moving fill/finish operations out of the Allston manufacturing facility; and the strongest quarter to date in the ongoing U.S. launch of Synvisc-One.
The company also continues to make progress in executing its plan for shareholder value creation announced in May. The plan builds on the series of operational and organizational changes the company has made over the past year.
Last month, Genzyme completed a debt offering of $1 billion. This debt was used to enter into an accelerated stock buyback for the first half of a $2 billion share repurchase. The full impact of this buyback on the company’s weighted average share count will be seen in the third and fourth quarters.
The company has made progress in its efforts to find strategic alternatives for its Genetics, Diagnostics, and Pharmaceuticals businesses, and is on-track to complete transactions by the end of this year.
Genzyme has retained independent consultants and has begun identifying potential efficiencies and cost reductions to improve its operating margins. The company is in the process of evaluating its global organization and cost structure to develop a multi-year action plan which will be implemented beginning this fall.
In the area of corporate governance, Genzyme settled its proxy contest and shareholders re-elected all of the company’s directors. In addition, Genzyme’s board appointed Steven Burakoff, M.D., Eric Ende, M.D., and Dennis Fenton, Ph.D., as directors.
Product Supply Update
Cerezyme
Production of Cerezyme is now in-line with historical averages and the Allston facility remains fully operational. With production proceeding successfully, Genzyme will begin increasing shipments in August. The company expects that patients will be able to begin increasing their doses in September and return to normal dosing in the fourth quarter. Genzyme will increasingly look to make therapy available to new patients in need during the fourth quarter as supply becomes available.
Fabrazyme
Genzyme continues its efforts to improve the productivity of the Fabrazyme manufacturing process, and has received both FDA and EMA approval to use the new working cell bank. As previously communicated, the current shipping allocations will remain in place for the third quarter. Shipments of Fabrazyme are expected to increase in the fourth quarter.
Since levels of demand, ordering patterns and dose regimens vary by region, Genzyme staff in countries around the world will provide patients and physicians with more information on the local impact of this guidance for each product. Because inventories remain limited, any manufacturing disruptions or delays in shipping can impact availability of Cerezyme and Fabrazyme.
At the company’s new Framingham manufacturing facility, two bioreactors are currently operational and Fabrazyme engineering runs are planned for September. The facility is on-track for approval, anticipated in late 2011.
Consent Decree
During the second quarter, Genzyme began implementing changes to address requirements of the FDA consent decree, including transitioning fill/finish operations out of its Allston facility. The company signed a new agreement with Hospira Worldwide Inc., which will provide fill/finish manufacturing services for some of the company’s products. Genzyme has transitioned fill/finish for Cerezyme and Myozyme to its Waterford, Ireland facility, and is in the process of transferring Thyrogen® (thyrotropin alfa for injection) and Fabrazyme fill/finish to Hospira. Process validation runs for Thyrogen and Fabrazyme are underway at Hospira, and the company is on-track to meet its late November 2010 deadlines to complete this transition for all Thyrogen and Fabrazyme that is sold in the United States.
2010 Financial Guidance
Genzyme is providing new 2010 financial guidance based on several factors, including: updated information regarding Cerezyme and Fabrazyme supply; the consent decree; and the estimated impact of foreign exchange, health care reform in the United States, and new product pricing being implemented in the European Union. Please see the attached guidance sheet for additional detail and a reconciliation to the company’s previous guidance.
Cerezyme revenue is expected to be $725 million - $775 million and Fabrazyme revenue is expected to be $200 million - $220 million. Total 2010 revenue is expected to be $4.4 billion - $4.5 billion. Non-GAAP EPS is expected to be $0.40 - $0.50 per diluted share in the third quarter, $0.90 - $1.00 per diluted share in the fourth quarter, and $1.90 - $2.00 per diluted share for the full year. This new guidance excludes revenue and expenses in the second half of the year for the three businesses that are expected to be divested.
Second Quarter Results and Business Updates
Within the Personalized Genetic Health segment, second-quarter sales of Myozyme® (alglucosidase alfa) increased 16 percent to $92.1 million from $79.3 million in the same period in 2009. Second-quarter revenue reflects a negative $3.7 million impact of foreign exchange. Genzyme on May 24 received FDA approval for Lumizyme, and has implemented a Risk Evaluation and Mitigation Strategy (called the Lumizyme ACE Program) to ensure that the appropriate patients receive Lumizyme commercially.
Genzyme has initiated this program with the health care professionals involved in the Alglucosidase Alfa Temporary Access Program (ATAP), the program created in 2007 through which Genzyme has provided therapy free of charge to nearly 200 patients prior to commercial approval of Lumizyme. Genzyme will keep ATAP open until August 20, 2010 to ensure that patients have uninterrupted therapy while working to enroll participants in the Lumizyme ACE Program. Genzyme has also begun working with U.S. health care professionals to enable those adult patients who have been waiting to access treatment to begin Lumizyme therapy.
Second-quarter sales of Cerezyme were $138.7 million compared with $298.1 million in the second quarter of last year and sales of Fabrazyme were $39.5 million, compared with $134.3 million in the same period last year. Due to supply constraints, Cerezyme was shipped at 50 percent of demand and Fabrazyme was shipped at 30 percent of demand for the entire second quarter.
Within the Biosurgery segment, sales of Synvisc® (hylan G-F 20) increased 31 percent to $107.7 million from $82.4 million in last year’s second quarter, driven by Synvisc-One, which was launched in the United States in March 2009. Growth is resulting both from gains in market share and from overall expansion of the U.S. viscosupplement market, which grew approximately 14 percent in the first half of 2010 compared with the same period last year. Synivsc-One now represents two-thirds of all U.S. Synvisc revenue.
Within the Renal and Endocrinology segment, sales of Genzyme’s sevelamer therapies, Renvela® (sevelamer carbonate) and Renagel® (sevelamer hydrochloride), were $170.1 million, compared with $175.4 million during the second quarter of 2009, reflecting increased U.S. sales volume offset by price decreases being implemented by some E.U. countries. The ongoing launch of Renvela in Europe continues to progress well, with launches in the key markets of France, Spain, Italy and the U.K. expected to take place during the second half of 2010.
Sales of Thyrogen increased 8 percent to $46.3 million from $42.9 million in the second quarter of 2009. In accordance with terms of the consent decree, a Dear Healthcare Provider letter describing the patients for whom FDA considers Thyrogen to be medically necessary is currently being included in all U.S. shipments of Thyrogen. Genzyme has limited its promotional activities in the United States to be consistent with the requirements of the consent decree. Once fill/finish operations are transferred to Hospira, the criteria will no longer be in effect and Genzyme will resume normal U.S. promotional work.
Total revenue for the Hematology and Oncology segment, including the oncology products acquired from Bayer in May 2009, increased 58 percent to $176.5 million from $112.0 million in last year’s second quarter.
Within this segment, sales of Mozobil® (plerixafor injection) nearly doubled to $22.1 million from $11.7 million in the second quarter last year, reflecting a 23 percent increase in U.S. sales and the robust launch in Europe. Sales of Thymoglobulin® (anti-thymocyte globulin, rabbit) increased 9 percent to $58.2 million compared with $53.6 million in the second quarter of 2009, with significant growth coming from the Asia-Pacific region.
Second-quarter growth in this segment was also driven by sales of Clolar® (clofarabine injection), which increased 29 percent to $25.5 million from $19.7 million in the same period a year ago, with volume growth occurring in all major markets. Data from the phase 3 trial of Clolar in combination with an approved therapy in second-line adult acute myeloid leukemia are expected in the fourth quarter, and positive findings would support regulatory filings for a label expansion in this indication.
Other revenue – which includes the company’s Genetics, Diagnostics, and Pharmaceuticals businesses – was $130.0 million in the second quarter of 2010 compared with $143.1 million in the same period last year.
Operating Expenses
Genzyme’s GAAP SG&A was $402.5 million, compared with $354.1 million in the second quarter of 2009. Non-GAAP SG&A was $375.9 million compared with $316.3 million in the same period last year. SG&A reflects expenses associated with the acquisition of the Bayer oncology products, the proxy contest, and consent decree legal fees.
The company’s GAAP R&D was $225.6 million compared with $210.5 million in last year’s second quarter; non-GAAP R&D was $211.5 million compared with $190.7 million in the second quarter of 2009.
Late-Stage R&D Programs
Genzyme has a strong late-stage pipeline that is expected to help drive long-term growth:
Five-year follow-up data from Genzyme’s phase 2 trial of alemtuzumab in multiple sclerosis have been accepted for presentation at the European Committee for Treatment and Research in Multiple Sclerosis annual meeting in October. Two phase 3 studies are ongoing and data are expected next year. Genzyme has finalized its regulatory filing strategy, and now plans to await results of both phase 3 studies and file with data from the two trials to provide the most robust submission. The company expects to file for U.S. and E.U. approval in early 2012, and has been granted fast track status by the FDA for this submission.
Enrollment is underway in three global, multi-center, phase 3 trials of eliglustat tartrate, Genzyme’s investigational oral therapy for patients with Gaucher disease type 1. There are currently a total of 48 active sites for these trials, with additional sites preparing to begin enrollment. This therapy has the potential to transform the treatment experience for patients by providing a daily oral capsule option instead of bi-weekly infusions.
Genzyme and Isis Pharmaceuticals Inc. expect to report data this quarter from two phase 3 studies of mipomersen: one includes patients with severe hypercholesterolemia and the other includes hypercholesterolemic patients at high risk for coronary heart disease. These two studies are the last of the four phase 3 trials that will contribute to the initial U.S. and E.U. regulatory filings for the product, which will seek approval for the treatment of patients with the genetic disease homozygous familial hypercholesterolemia. These two filings may also include patients with severe hypercholesterolemia, and are anticipated in the first half of 2011.
About Genzyme
One of the world's leading biotechnology companies, Genzyme is dedicated to making a major positive impact on the lives of people with serious diseases. Since 1981, the company has grown from a small start-up to a diversified enterprise with more than 12,000 employees in locations spanning the globe and 2009 revenues of $4.5 billion. In 2010, Genzyme was named to the Fortune 500.
With many established products and services helping patients in 100 countries, Genzyme is a leader in the effort to develop and apply the most advanced technologies in the life sciences. The company's products and services are focused on rare inherited disorders, kidney disease, orthopaedics, cancer, transplant, and immune disease. Genzyme's commitment to innovation continues today with a substantial development program focused on these fields, as well as cardiovascular disease, neurodegenerative diseases, and other areas of unmet medical need.
Genzyme’s press releases and other company information are available at www.genzyme.com and by calling Genzyme’s investor information line at 1-800-905-4369 within the United States or 1-678-999-4572 outside the United States...http://ih.advfn.com/p.php?pid=nmona&article=43683902&symbol=N%5EGENZ
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