sidesh0wb0b
17 years ago
Schering-Plough Schedules Webcast for Annual Meeting of Shareholders
Friday May 9, 1:37 pm ET
KENILWORTH, N.J., May 9 /PRNewswire-FirstCall/ -- Schering-Plough Corporation (NYSE: SGP - News) will hold its Annual Meeting of Shareholders Friday, May 16, 2008, in Memphis, Tenn. At 8 a.m. (CDT) (9 a.m. EDT) on that day, a live Webcast of the meeting will be available to all interested parties via the corporate Web site, www.schering-plough.com.
At the Annual Meeting, Fred Hassan, Chairman and CEO, will report to shareholders on the company's performance and the progress being achieved toward its long-term goals.
Those wishing to listen live to the Webcast of the Annual Meeting should go to the Investor Relations section of the Schering-Plough corporate Web site, www.schering-plough.com, and click on the "Presentations/Webcasts" link. A replay of the Webcast will be available via the Web site later that day.
Schering-Plough is an innovation-driven, science-centered global health care company. Through its own biopharmaceutical research and collaborations with partners, Schering-Plough creates therapies that help save and improve lives around the world. The company applies its research-and-development platform to human prescription and consumer products as well as to animal health products. Schering-Plough's vision is to "Earn Trust, Every Day" with the doctors, patients, customers and other stakeholders served by its colleagues around the world. The company is based in Kenilworth, N.J., and its Web site is www.schering-plough.com.
sidesh0wb0b
17 years ago
UPDATE 1-Bristol-Myers Squibb CEO buys 100,000 shares
Thu May 8, 2008 3:46pm EDT
By Kristina Cooke and Ransdell Pierson
NEW YORK, May 8 (Reuters) - The chief executive of drugmaker Bristol-Myers Squibb Co (BMY.N: Quote, Profile, Research) bought 100,000 company shares in his first open-market purchase since taking the top post nearly two years ago, according to a regulatory filing on Thursday.
James Cornelius purchased $2.3 million worth of stock on Wednesday for $22.70 to $22.92 a share, according to a U.S. Securities and Exchange Commission filing.
On the same day, the drugmaker said it was evaluating its 2008 earnings forecast and would update its full-year outlook by the end of the second quarter. For details, see [ID:nWNAS2439]
Cornelius, who became chief executive in 2006, is the first insider to directly buy on the open market since at least February 2001, according to insider filing tracker InsiderScore.com.
Bristol-Myers Squibb shares, which were little changed at $22.81 on Thursday, are down 14.3 percent year-to-date.
The chief executive of rival Schering-Plough Corp (SGP.N: Quote, Profile, Research), Fred Hassan, bought about $2 million of his company's common stock, or 110,000 shares, two weeks ago, keeping an earlier pledge to make the personal investment as a vote of confidence in the struggling drugmaker.
Hassan announced his plans to buy the stock on Jan. 18, after a failed clinical trial of the company's big-selling Vytorin cholesterol drug spurred a 20 percent decline in the shares that week.
The financial picture of New York-based Bristol-Myers has greatly improved in recent quarters, following the brief U.S. appearance of a generic form of its blockbuster blood clot preventer, Plavix, that badly hurt the branded drug.
U.S. supplies of the generic, made by privately held Canadian drugmaker Apotex, dried up last year after a U.S. judge banned continued shipments of the cheaper copycat. Consequently, first quarter Plavix sales jumped almost 40 percent and sales of other important Bristol-Myers drugs also chalked up solid sales gains.
Bristol last month reaffirmed its full-year 2008 forecast for earnings from continuing operations of $1.60 to $1.70 per share, excluding special items. That translates into growth of as much as 15 percent from last year.
It also stuck to an earlier forecast that earnings would grow by at least 15 percent a year from a 2007 base through 2010.
But analysts cautioned that Bristol-Myers would likely face lower earnings by 2012, after the U.S. patent lapses on Plavix, because revenue from newly introduced products will probably be unable to offset its lost sales. (Additional reporting by Ransdell Pierson; Editing by Tom Hals and Andre Grenon)
sidesh0wb0b
17 years ago
Innocoll Announces Dosing of First Patient in US Phase 2 Clinical Trial to Investigate CollaRx(R) GENTAMICIN TOPICAL for the Prevention of Diabetic Foot Infections
Wednesday April 30, 7:00 am ET
ASHBURN, Va., April 30 /PRNewswire/ -- Innocoll, Inc., a privately-held biopharmaceutical company, announced that the last of three planned phase 2 clinical trials sponsored by its wholly owned subsidiary, Innocoll Technologies Ltd, to investigate CollaRx® GENTAMICIN TOPICAL for the treatment and prevention of infected diabetic foot ulcers, has commenced dosing. CollaRx GENTAMICIN TOPICAL is a biodegradable and fully resorbable Gentamicin-Collagen Sponge formulated and manufactured using Innocoll's proprietary collagen-based drug delivery technology, CollaRx. Upon application to a wound, the product releases gentamicin, a broad-spectrum, aminoglycoside antibiotic (having a concentration-dependent mechanism of action), for local action. This achieves a high concentration of drug at the target tissue, while maintaining low systemic levels well below the toxicity threshold.
The product is already approved and marketed in Europe and other non-US territories as a surgical implant for the treatment of localized, deep tissue infections and the prevention of surgical site infections in both hard and soft tissues; and is also in Phase 3 clinical development in the US for the prevention of surgical site infections. The development of the topical indication is based upon a series of published clinical case studies and anecdotal reports from clinicians where the marketed implant product has been used topically for treatment of infected chronic wounds of various etiologies. These data support its effectiveness for such clinical applications, particularly in the treatment of infected diabetic foot ulcers.
CollaRx GENTAMICIN TOPICAL is currently under investigation for the treatment and prevention of diabetic foot infections of varying severity in a series of multi-centred phase 2 clinical trials. The first and second trials are investigating the product as a mono-antibiotic therapy for the treatment of mildly infected diabetic ulcers and as an adjunct to systemic antibiotic therapy for treating moderately infected ulcers, as defined according to Infectious Disease Society of America (IDSA) guidelines. This third and final phase 2 trial will investigate the product for the prevention of diabetic foot infections.
Chronic ulcerations are often colonized or contaminated with bacterial pathogens that can prevent ulcers from healing. Many such wounds become clinically infected and require treatment with antibiotics. However, early diagnosis of diabetic foot infections is a clinical challenge as typical signs and symptoms of infection, such as pain, redness, or elevated circulating inflammatory markers, can be absent in individuals with neuropathic or neuroischaemic ulcers. Failure to diagnose and treat such infections can lead rapidly to the infection spreading, with the possibility of tissue necrosis, gangrene, osteomyelitis, and ultimately the prospect of a lower leg amputation.
Currently there are no antibiotics on the market specifically indicated for the prevention of diabetic foot infections. There is also reluctance by practitioners to use existing, systemically-acting antibiotics prophylactically because of concerns with systemic side effects and fear of propagating bacterial resistance with widespread use. Furthermore, diabetic ulcers are often associated with vascular disease and restricted peripheral blood flow, which may render systemically acting antibiotics less effective. By achieving very high localized concentrations of antibiotic, CollaRx GENTAMICIN TOPICAL is designed to overcome these concerns and this trial has received support from leading podiatrists and infectious disease specialists in the US as the first of its kind. Market research independently performed by L.E.K. Consulting has forecast peak annual US sales revenues for CollaRx GENTAMICIN TOPICAL approaching US$270 million, when limiting the sales projections to diabetic foot indications only.
Dr. Michael Myers, Innocoll's President and CEO commented, "This is the third and final phase 2 trial planned for the development of our Gentamicin- Collagen sponge as a topically-acting antibiotic for the treatment and prevention of diabetic foot infections. It represents the seventh phase 2 or phase 3 clinical trial that we have initiated within the past six months on three different products, all of which are fully funded by Innocoll. Furthermore, we have an additional phase 2 and another phase 3 trial that we anticipate dosing within the next 3 months, illustrating our strong commitment to continue investing heavily in our exciting and innovative pipeline"
About Infected Diabetic Foot Ulcers
According to the Centers for Disease Control and Prevention (CDC), the estimated incidence of diabetes in the US exceeds 1.5 million new cases annually, with an overall prevalence of 20.8 million people, or 7% of the US population. By 2030, the International Diabetes Federation predicts that the Global prevalence of diabetes will almost double from 193 million people (estimated in 2003) to 366 million.
An estimated 15% of patients with diabetes will develop a lower extremity ulcer during the course of their disease. According to a large prospective study, approximately 7% of diabetic patients with foot ulcers will require an amputation. Diabetic foot is the most common cause of nontraumatic lower extremity amputations in the US and Europe, with an average of 82,000 amputations per year in the US costing an estimated $1.6 billion annually. The estimated cost of foot ulcer care in the US ranges from $4,595 per ulcer episode to more than $28,000, for the 2 years post diagnosis. The total annual cost of foot ulcer care in the US has been estimated to be as high as $5 billion.
About Innocoll, Inc.
Innocoll is a privately held, biopharmaceutical company focused on biodegradable surgical implants and topically applied healthcare products. It develops and manufactures a range of pharmaceutical products and medical devices using its proprietary collagen-based technologies, CollaRx® and Liquicoll®. Innocoll 's lead product, Gentamicin Surgical Implant for the treatment and prevention of surgical site infections, is approved for sale in 49 countries in Europe, Latin America, Middle East, Africa and Asia and is marketed under the following trade names; COLLATAMP® G, COLLATAMP® EG, SULMYCIN® IMPLANT, GARAMYCIN® SCHWAMM, DURACOL®, DURACOLL®, GENTACOL®, GENTACOLL®, GARACOL®, GARACOLL®, and CRONOCOL®. In 2005, Innocoll acquired the worldwide marketing rights for this product from Essex Chemis AG, an affiliated company of Schering-Plough Corporation (NYSE: SGP - News) and in August 2007 sold its marketing rights, with the exception of the US, to EUSA Pharma. Gentamicin Surgical Implant is currently in phase 3 development in the US for the prevention of surgical site infections. Other late stage pharmaceutical products in Innocoll's development pipeline include CollaRx Gentamicin Topical for the treatment and prevention of infected diabetic foot ulcers and CollaRx Bupivacaine Implant for the management of post-operative pain, both of which are currently in Phase 2 development. For more information, please visit www.innocollinc.com .
sidesh0wb0b
17 years ago
Law Offices of Howard G. Smith Announces Investigation on Behalf of Current and Former Employees of Schering-Plough Corporation Who Invested in the Schering-Plough Retirement Plan
Wednesday April 9, 8:37 pm ET
BENSALEM, Pa., April 9 /PRNewswire/ -- Law Offices of Howard G. Smith announces that it is investigating claims against Schering-Plough Corporation ("Schering-Plough" or the "Company")(NYSE: SGP - News) concerning whether the Schering-Plough Retirement Plan (the "Plan") imprudently invested in Schering-Plough stock and whether the Plan's administrators breached their fiduciary duties to the Plan's participants in violation of the Employee Retirement Income Security Act of 1974.
The investigation concerns whether Schering-Plough and other administrators of the Plan failed to prudently and loyally manage the Plan's investments in Schering-Plough Corp. stock by continuing to offer Company stock when the stock was no longer a prudent investment for participants' retirement savings.
If you are a current or former employee who participated in, or continues to participate in, the Schering-Plough Retirement Plan and have information or would like to learn more about these claims, please contact Howard G. Smith, Esquire, of Law Offices of Howard G. Smith, 3070 Bristol Pike, Suite 112, Bensalem, Pennsylvania 19020 by telephone at (215) 638-4847, Toll-Free at (888) 638- 4847, or by email to howardsmithlaw@hotmail.com.
If you wish to discuss this action or have any questions concerning this Notice or your rights or interests with respect to these matters, please contact Howard G. Smith, Esquire, of Law Offices of Howard G. Smith, 3070 Bristol Pike, Suite 112, Bensalem, Pennsylvania 19020, by telephone at (215) 638-4847, Toll-Free at (888) 638-4847, by email to howardsmithlaw@hotmail.com.
sidesh0wb0b
17 years ago
Schering's Buy of Organon Had to Happen
04/09/08 - 03:42 PM EDT
OKLAHOMA CITY -- The strategy behind Schering-Plough's (SGP - Cramer's Take - Stockpickr) pricey acquisition of Organon is starting to add up.
When news of the $14.4 billion deal broke a year ago, Schering-Plough seemed to be doing just fine on its own. Thanks to brisk sales of Vytorin and Zetia, two blockbuster cholesterol-lowering drugs it co-marketed with Merck (MRK - Cramer's Take - Stockpickr), Schering-Plough boasted one of the fastest growth rates in the industry.
By purchasing Organon, a European drug maker viewed as a laggard by some, Schering-Plough appeared to be taking unnecessary risks.
Besides, Schering-Plough still had some unfinished business: Years earlier, the company had set out to prove that Vytorin -- a combination of Zetia and Zocor -- worked better than Zocor alone. The company had already established that Vytorin dramatically lowered cholesterol, but it hoped to show that the drug reduced the plaque that leads to actual heart attacks as well.
ENHANCE, the first clinical trial designed to offer this proof, had formally ended in April 2006. Schering-Plough originally planned to release the study's results at a conference that fall but missed that deadline -- and two others that followed. Ultimately, the devastating results -- indicating that Vytorin reduces plaque no more than Zocor alone -- would remain unknown for almost two full years.
In the meantime, Schering-Plough kept reassuring investors. "We are in the process of working on the data and making good progress, but we want to do it the right way," CEO Fred Hassan explained on a January 2007 conference call. "We're in no rush to get a marketing thing out of this."
Instead, Schering-Plough rushed forward six weeks later with the surprising news of the Organon takeover instead. In the process, the company effectively changed the subject.
Meanwhile, wooed by an estimated $200 million worth of advertisements, consumers went on to buy a record $5 billion worth of Vytorin and stand-alone Zetia that year. Schering-Plough, which splits the proceeds with larger Merck, relied on those two drugs for roughly half its annual profit.
Buying Organon, which offered several established drugs and five more in late-stage trials, promised Schering-Plough a broader product base. But Schering-Plough paid a high price -- surpassing half its current market value -- for that diversity. It also settled for a target that had just been shunned by one of its larger peers.
Skeptics questioned the deal's wisdom from the start. Since the formal release last month of the ENHANCE results -- which indicated that Vytorin reduces plaque no more than Zocor alone -- some have started to dwell on the timing of that deal as well.
Schering-Plough failed to answer questions about whether ENHANCE had influenced its decision to buy Organon. The company stuck with information provided in its formal press releases instead.
Early this year, however, Schering-Plough issued a handy outline that traces the evolution of ENHANCE. That timeline offers an inside view of the challenges that Schering-Plough faced as it purchased Organon and set out to reshape the company.
more at http://www.thestreet.com/_yahoo/newsanalysis/healthcare/10411338.html?cm_ven=YAHOO&cm_cat=FREE&cm_ite=NA
sidesh0wb0b
17 years ago
SGP income statement...
PERIOD ENDING 31-Dec-07 30-Sep-07 30-Jun-07 31-Mar-07
Total Revenue 3,725,000 2,812,000 3,178,000 2,975,000
Cost of Revenue 1,567,000 925,000 976,000 937,000
Gross Profit 2,158,000 1,887,000 2,202,000 2,038,000
Operating Expenses
Research Development 855,000 668,000 696,000 707,000
Selling General and Administrative 1,635,000 1,261,000 1,359,000 1,213,000
Non Recurring 3,806,000 20,000 11,000 1,000
Others - - - -
Total Operating Expenses - - - -
Operating Income or Loss (4,138,000) (62,000) 136,000 117,000
Income from Continuing Operations
Total Other Income/Expenses Net 357,000 433,000 53,000 85,000
Earnings Before Interest And Taxes (3,215,000) 876,000 680,000 689,000
Interest Expense 125,000 44,000 39,000 37,000
Income Before Tax (3,340,000) 832,000 641,000 652,000
Income Tax Expense (14,000) 82,000 103,000 87,000
Minority Interest - - - -
Net Income From Continuing Ops (3,326,000) 750,000 538,000 565,000
Non-recurring Events
Discontinued Operations - - - -
Extraordinary Items - - - -
Effect Of Accounting Changes - - - -
Other Items - - - -
Net Income (3,326,000) 750,000 538,000 565,000
Preferred Stock And Other Adjustments (38,000) (37,000) (21,000) (22,000)
Net Income Applicable To Common Shares ($3,364,000) $713,000 $517,000 $543,000
sidesh0wb0b
17 years ago
Will This Drug Help Schering-Plough Recover?
By Brian Orelli March 12, 2008
2 Recommendations
Schering-Plough (NYSE: SGP) must have held its breath or had someone scare it right before it went into its FDA panel hearing yesterday. The hiccups that I postulated Schering might face during the meeting never really materialized.
In fact, the panel voted unanimously to recommend that the FDA approve Bridion, Schering's drug used to reverse the effects of muscle blocks during surgery. The panel said that the drug could be used in all the situations that Schering had requested, including emergencies where patients need to be revived quickly. On the safety front, the panel recommended post-marketing studies to make sure that the minor problems seen in the clinical trials actually are minor. Overall, the results of the panel's meeting were the best Schering could have hoped for.
The FDA doesn't always follow a panel's recommendation -- think Genentech (NYSE: DNA) last month -- but, given the relatively positive executive summary the FDA presented to the panel, an approval seems likely in this case.
The only question now is how well Schering will be able to market the drug. Bridion works much better than drugs made by generic-drug makers Novartis (NYSE: NVS), Baxter (NYSE: BAX), and Hospira (NYSE: HSP), but it's unclear whether the quicker recovery time will justify the higher price tag. In many patients, no drug is used, and the body clears the muscle block naturally, so quicker clearly isn't necessarily better for all patients.
Schering needs Bridion to succeed, not only to justify its $14 billion acquisition of the Organon BioSciences unit of Akzo Nobel (Nasdaq: AKZOY), which developed the drug, but also because Schering needs to replace the growth lost in its cholesterol drug partnership with Merck (NYSE: MRK), after a post-marketing study suggested that drug might not work as well as the duo hoped.
Fortunately, Schering has a well-stocked pipeline, so if Bridion doesn't live up to its potential, the drugmaker has other drugs right behind it.
sidesh0wb0b
17 years ago
Schering Anesthesia Data Raise Concerns-US FDA Rep
Tue Mar 11, 2008 3:04pm EDT
SILVER SPRING, Md. (Reuters) - Recently submitted data on allergic reactions related to a Schering-Plow Corp (SGP.N: Quote, Profile, Research) drug aimed at reversing the effects of anesthesia raise concerns, a U.S. regulator said on Tuesday.
A Food and Drug Administration advisory panel is weighing the risks and benefits of the drug Bridion, known generically as sugammadex. The panel will vote later today on whether to recommend approval.
Bob Rappaport, director of the FDA's division of anesthesia, analgesia and rheumatology drugs, said data received in the last two weeks by the FDA "raise concerns" about the drug's safety.
The agency had been waiting for a safety update.
A Schering-Plow official told the panel that only one patient suffered from so-called hypersensitivity -- an allergic reaction marked at times by rash, flushing and heart disturbances. That case was mild and resolved itself, said Patrick Boen, a senior medical director at Schering-Plough's anesthesia unit.
FDA staff cited eight cases of hypersensitivity, though an agency reviewer noted that only three cases may be related to the drug itself based on the timing of the reaction.
The "safety review is ongoing," and issues to be resolved include the hypersensitivity reactions and abnormal electrical activity in the heartbeat, FDA staff said in review documents.
None of the hypersensitivity reactions rose to the level of "serious," but the link between the drug and heart-related side effects cannot be ruled out, the FDA said.
The drug Bridion aims to reverse the muscular blocking effects of certain muscle relaxants and help patients recover more quickly from anesthesia after medical procedures.
The FDA typically takes the advice of its advisory panels.
Schering-Plow shares rose 1 cent to $19.66 in late morning trade on the New York Stock Exchange.
(Reporting by Kim Dixon, editing by Gerald E. McCormick and Derek Caney)
sidesh0wb0b
17 years ago
Schering-Plough Announces Filing of U.S. Application for OTC ZEGERID(R)
Tuesday March 11, 8:00 am ET
KENILWORTH, N.J., March 11 /PRNewswire-FirstCall/ -- Schering-Plough Corporation (NYSE: SGP - News) today announced a submission to the U.S. Food and Drug Administration (FDA) of a New Drug Application (NDA) for ZEGERID® (omeprazole/sodium bicarbonate) in the dosage strength of 20 mg of omeprazole as a branded over-the-counter (OTC) product to treat frequent heartburn.
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The NDA was submitted under the terms of a license agreement with Santarus, Inc. of San Diego, Calif., which was signed in October 2006 for the exclusive U.S./Canadian rights to market OTC ZEGERID proton pump inhibitor (PPI) products using Santarus' patented technology.
"Schering-Plough is looking forward to working with the FDA to bring this prescription product to consumers as an OTC treatment for frequent heartburn," said John E. O'Mullane, B.Sc., Ph.D., group vice president, Research and Development, Schering-Plough Consumer Health Care. "When approved, ZEGERID will be a valuable addition to our expanding portfolio of gastrointestinal OTC products such as MiraLAX®, which was launched last year for the treatment of occasional constipation."
Under the agreement with Santarus, Schering-Plough is responsible for the development, manufacturing and commercialization of ZEGERID (omeprazole/sodium bicarbonate) OTC products for heartburn-related indications in the U.S. and Canada. Santarus continues to manufacture, promote and sell its ZEGERID (omeprazole/sodium bicarbonate) prescription products in both 20 mg and 40 mg dosage strengths of omeprazole for the U.S. prescription market for PPI products.
Product Description
ZEGERID® (omeprazole/sodium bicarbonate) contains omeprazole, a proton pump inhibitor (PPI), and sodium bicarbonate, which raises the gastric pH and thus protects omeprazole from acid degradation.
Important Safety Information about ZEGERID
The most frequently reported adverse events with ZEGERID are headache, diarrhea, and abdominal pain. Symptomatic response to therapy does not preclude the presence of gastric malignancy. Atrophic gastritis has been noted occasionally in gastric corpus biopsies from patients treated long term with omeprazole.
ZEGERID contains sodium bicarbonate. This should be taken into consideration for patients on a sodium-restricted diet.
ZEGERID is contraindicated in patients with known hypersensitivity to any component of the formulation.
sidesh0wb0b
17 years ago
Schering-Plough to Webcast Presentation by CEO Fred Hassan at Lehman Brothers Eleventh Annual Global Healthcare Conference
Monday March 10, 5:08 pm ET
KENILWORTH, N.J., March 10 /PRNewswire-FirstCall/ -- Schering-Plough Corporation (NYSE: SGP - News) will provide a live audio webcast of a presentation by Fred Hassan, chairman and Chief Executive Officer, at the Lehman Brothers Eleventh Annual Global Healthcare Conference in Miami, Fla., on Tuesday, March 18, at approximately 10:15 a.m. (ET). Hassan is expected to talk on the company's performance and the integration of Organon BioSciences N.V., acquired in November 2007.
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A live audio webcast of the presentation will be available by going to the Investor Relations section of the Schering-Plough corporate Web site, http://www.schering-plough.com, and clicking on the "Presentations/Webcasts" link. A replay of the webcast will be available later that day.
Schering-Plough is an innovation-driven, science-centered global health care company. Through its own biopharmaceutical research and collaborations with partners, Schering-Plough creates therapies that help save and improve lives around the world. The company applies its research-and-development platform to human prescription and consumer products as well as to animal health products. In November 2007, Schering-Plough acquired Organon BioSciences, with its Organon human health and Intervet animal health businesses, marking a pivotal step in the company's ongoing transformation. Schering-Plough's vision is to "Earn Trust, Every Day" with the doctors, patients, customers and other stakeholders served by its colleagues around the world. The company is based in Kenilworth, N.J., and its Web site is http://www.schering-plough.com.
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