iwfal
14 years ago
I think it’s presumptuous of you to assume that Lambda will be substantially better than Locteron and other drugs of its ilk.
Locteron is still ifn-a. With all the widespread receptors outside the liver. ifn-L is inherently different. Lets look at the side effects for those where we know both drugs have measured it and the numbers in one trial or the other were big enough to at least possibly result in a stat sig difference:
From the ifn-L ph 1 (56 patients) compared to the Locteron ph 2a (32 patients) trial:
Fever: <=4% vs 19% (less than 3 out of 56) p<0.025
Myalgia: 11% vs 41% p=0.002
Nausea: 13% vs 3%? (it is mentioned as 'minimal' in the PR, but not listed at all on the poster so probably 1/32). p=0.24
Headache: 9% vs 41% p<0.001
Neutropenia: Comparing the Lambda ph i vs Locteron ph i (last is a small patient set) -0.3E9/Liter vs -2E9/Liter.
Obviously this was not a randomized comparison and so is subject to substantial noise. But nonetheless it trends as you'd expect from a drug that hits receptors throughout the body vs of drug with substantially more limited receptor distribution. Note also that if you assume that they actually measured all the same things, but just didn't report them because they didn't see enough (3+ was the limit on the Lambda poster, 2+ for Locteron), then Locteron comes out meaningfully worse on Arthralgia, weakness, taste alteration and sleep disorder. Lambda comes out worse on fatigue (note that I suspect that "fatigue" and "sleep disorder" are very related).
As for efficacy in G1 treatment naive at the likely carry forward dosage - in 8 patients Locteron showed 3.1 log decrease and ifn-L in 7 patients showed 2.8 log. Well within the error bars. And note that there is a reasonable bet that ifn-L can increase their dose (they acknowledged that they probably thought they hit MTD when they hadn't due to a dosing protocol error) and they curves all show that increasing dose would increase efficacy.
Altogether I'd agree it isn't guaranteed that Ifn-L is the better drug. But it is a moderately good bet.
brooklyn137
14 years ago
Assuming you are right about the first, Hep B not Hep A, the point is the same, they are starting a trial in an indication that would lead them to claim those milestones.
As to the second, 286 million milestones, you are correct and I made a mistake. But, if you are correct in that the total sales milestone to earn the payment is between 500 and one billion, then you are saying that the total sales of lamda would not be 500 million or a billion? If so, you are clearly wrong.
brooklyn137
14 years ago
This is a horrible thing. If you assume that lamda will be successful, the company is being sold for negative 30 million dollars. That's right, it's not even being given away, they are paying BMY to take it.
BMY still owes about 800 million in milestones. ZGEN has, give or take, 150 million in cash. The number they are giving as the real sale number (offer minus cash on hand) is 770 million. It may be less, but using their number, that's 30 million less than the milestones that are due.
The only hope is that another company will see the bargain and step in. After all, if they offer zero, it's a better offer.
I don't generally like these suits which pop up all the time, but this time it's justified.
surf1944
14 years ago
Bristol-Myers agrees to buy ZymoGenetics for $885M
Bristol-Myers Squibb to buy ZymoGenetics for $885 million, or $9.75 per share in cash
NEW YORK (AP) -- Bristol-Myers Squibb Co. said Tuesday it will acquire biotechnology partner ZymoGenetics Inc. for $885 million in another move by a major drugmaker to boost its pipeline by snapping up a smaller developer.
The New York drugmaker's $9.75-per-share bid represents a 77 percent premium to Zymogenetics' closing price of $5.51. Bristol-Myers' said the deal is worth $735 million excluding ZymoGenetics' cash on hand. Both companies have approved the deal and the board of ZymoGenetics is recommending that shareholders support the bid.
ZymoGenetics stock jumped $4.50, or nearly 85 percent, to $9.76 in aftermarket trading.
Seattle-based ZymoGenetics makes Recothrom, a drug used to reduce bleeding during surgeries. Since January 2009 it has been working with Bristol-Myers to develop a potential hepatitis C treatment called pegylated interferon lambda. That drug is in midstage clinical testing, and the companies said it "could be an important contributor to Bristol-Myers Squibb's future growth" if it is approved.
ZymoGenetics is also testing experimental treatments for cancer and inflammatory disorders including atopic dermatitis.
"The acquisition of ZymoGenetics brings us full ownership of a promising investigational biologic that strengthens our very diversified Hepatitis C portfolio," said Lamberto Andreotti, CEO of Bristol-Myers Squibb.
Bristol-Myers is one of the world's largest drugmakers and sells Plavix, a blood thinner that is the world's second-best selling brand name drug. Its other products include the psychiatric disorder treatment Abilify, Reyataz and Sustiva for HIV, Sprycel for cancer, and Onglyza for diabetes.
However the company is looking for ways to shore up its growth in the coming years. The patents supporting Plavix will expire in 2012, allowing cheaper generic versions to enter the market and eroding sales. Bristol-Myers' blood pressure drug Avapro is likely to face generic competition the same year.
Sales of Plavix totaled $6.15 billion in 2009, and the company reported $1.28 billion in Avapro revenue.
The move comes as many big pharma companies face patent cliffs that have them racing to fill out their development pipelines through acquisitions. Biotechnology companies are particularly attractive because there is not yet a regulatory pathway for generic versions of biotech drugs. Last month Sanofi-Aventis took its $18.5 billion bid for Genzyme Corp. public after that biotech company rejected the offer as inadequate.
Shareholders holding 37 percent of Zymogenetics' stock have agreed to vote for the deal. Bristol-Myers said the acquisition will trim its profit by 3 cents per share in 2010 and by 7 cents per share in 2011.
Morgan Stanley and Kirkland & Ellis LLP are advising Bristol-Myers Squibb on the deal. Goldman, Sachs & Co. and Latham & Watkins LLP and Fenwick & West LLP are counsel to ZymoGenetics
fourkids_9pets
14 years ago
ZGEN SHORT INTEREST
Zymogenetics Incorporated
$ 5.30
ZGEN
-0.21
Daily Short Sale Volume - NEW
28.73 %
Short Interest (Aggregate Total)
3,467,500
Days To Cover (Short Interest Ratio)
7.3
Short Percent of Float
7.97 %
Daily Naked Short Selling List - NEW No
Short Interest - Prior
3,672,400
Short % Increase / Decrease
-5.58 %
Short Squeeze Ranking™
-9
% From 52-Wk High ($ 7.31 )
-27.50 %
% From 52-Wk Low ($ 3.70 )
43.24 %
% From 200-Day MA ($ 5.41 )
-2.03 %
% From 50-Day MA ($ 4.43 )
19.64 %
Price % Change (52-Week)
-15.47 %
Shares Float
46,260,000
Total Shares Outstanding
85,737,829
% Owned by Insiders
38.07%
% Owned by Institutions
51.20%
Market Cap.
$ 454,410,510
Trading Volume - Today
247,867
Trading Volume - Average
474,300
Trading Volume - Today vs. Average
33.42 %
Earnings Per Share
-0.39
PE Ratio
Record Date
2010-AugB
Sector
Healthcare
Industry
Biotechnology
Exchange
NAS
Data Provided Without Warranty
--
4kids
all jmo
fourkids_9pets
14 years ago
ZymoGenetics Sold to Bristol-Myers Squibb for $9.75 a Share - ZGEN due off After-Hours Halt at 5:50 p.m. ET, BMY Slips
BY Midnight Trader
— 5:29 PM ET 09/07/2010
05:29 PM Eastern Daylight Time, 09/07/2010 (MidnightTrader) --
Bristol-Myers Squibb Company (BMY) and ZymoGenetics (ZGEN) have signed a definitive agreement providing for the acquisition of ZymoGenetics (ZGEN) by Bristol-Myers Squibb (BMY) for $9.75 per share in cash. The transaction, with an aggregate purchase price of approximately $885 million, or approximately $735 million net of cash acquired, has been unanimously approved by the boards of directors of both companies. The board of directors of ZymoGenetics (ZGEN) intends to recommend that ZymoGenetics' (ZGEN) shareholders tender their shares in the tender offer. In addition, shareholders holding approximately 37% of the outstanding shares of ZymoGenetics' (ZGEN) common stock have entered into agreements with Bristol-Myers Squibb (BMY) to support the transaction and to tender their shares in the offer. BMY says the acquisition builds on long-standing commitment to virology; gains full rights to promising Phase II hepatitis C biologic, pegylated-interferon lambda; obtains FDA-approved specialty surgical biologic, RECOTHROM; attains early clinical and pre-clinical programs in oncology and immunoscience. ZGEN is halted; BMY is down 0.3%. Price: 5.30, Change: 0, Percent Change: 0
http://www.midnighttrader.com
surf1944
14 years ago
ZymoGenetics Initiates PEG-Interferon lambda Phase 2b Clinical Trial in Hepatitis C in Collaboration with Bristol-Myers Squibb
Press Release Source: ZymoGenetics, Inc. On Wednesday June 2, 2010, 6:00 am EDT
SEATTLE--(BUSINESS WIRE)--ZymoGenetics, Inc. (NASDAQ:ZGEN - News) today announced the initiation of the second part of a Phase 2 clinical trial with PEG-Interferon lambda (IL-29) and ribavirin in treatment-naïve patients with chronic hepatitis C virus (HCV) infection. ZymoGenetics is developing the investigational compound PEG-Interferon lambda in collaboration with Bristol-Myers Squibb Company (NYSE:BMY - News).
“We’ve moved forward into part B of our Phase 2 study of PEG-Interferon lambda in hepatitis C,” said Eleanor L. Ramos, M.D., Senior Vice President and Chief Medical Officer of ZymoGenetics. “In part B, we expect to generate a substantial body of data to inform the design of Phase 3 studies, which will assess the potential role of PEG-Interferon lambda in addressing the unmet medical need for a safer, more effective treatment for hepatitis C.”
The Phase 2 EMERGE study is an international, randomized multi-center clinical trial. The Phase 2a open label portion continues and is exploring a range of four doses. Based on antiviral effects after four weeks of treatment and accumulated safety data, doses were selected for the second part of the study (Phase 2b). A status report with top-line interim results from the Phase 2a clinical trial was disclosed by ZymoGenetics on May 4, 2010. The companies selected the three highest doses of PEG-Interferon lambda for inclusion in Phase 2b, namely 120 mcg, 180 mcg and 240 mcg.
The Phase 2b study will enroll approximately 600 patients with genotypes 1 – 4 chronic HCV infection. The study will assess the safety and antiviral efficacy of the three specified doses of PEG-Interferon lambda compared to PEGASYS®. Each cohort of approximately 150 patients will include at least 100 genotype 1 patients. Weekly subcutaneous doses of PEG-Interferon lambda or PEGASYS will be administered for 48 weeks in genotype 1 or 4 patients and for 24 weeks in genotype 2 or 3 patients. All patients will also receive daily ribavirin. The primary endpoint of the trial is the proportion of patients who achieve undetectable levels of HCV RNA after 12 weeks of therapy (complete Early Virological Response). Sustained virological response (SVR), defined as undetectable levels of HCV RNA 24 weeks after treatment, will also be assessed.
PEG-Interferon lambda
PEG-Interferon lambda (IL-29) is a novel interferon in development for hepatitis C. PEG-Interferon lambda is a member of the Type III lambda interferon family, which includes IL-28A, IL-28B and IL-29 (also known as interferon lambda 2, 3, and 1, respectively). Type III interferons signal through a different receptor than type I interferons, such as interferon alpha. The native human interferon lambda proteins are generated by the immune system in response to viral infection. A Phase 1b clinical trial was conducted in patients with relapsed HCV, in which PEG-Interferon lambda was administered over four weeks in combination with ribavirin.
surf1944
14 years ago
ZymoGenetics Announces Upcoming Presentation of Positive IL-21 Phase 2 Results in Metastatic Melanoma at ASCO Meeting
Encouraging Objective Response Rate and Progression-Free Survival Estimate Reported in Abstract
Press Release Source: ZymoGenetics, Inc. On Thursday May 20, 2010, 6:10 pm
SEATTLE--(BUSINESS WIRE)--ZymoGenetics, Inc. (NASDAQ:ZGEN - News) announced that final progression-free survival results will be presented from a Phase 2 clinical trial in patients with Stage 4 metastatic melanoma at the American Society of Clinical Oncology (ASCO) annual meeting in Chicago on June 5, 2010 in an oral presentation. The open-label multi-center clinical trial evaluated 3 dose regimens of Interleukin 21 (IL-21) in 40 patients with no prior systemic therapy for metastatic melanoma.
The ASCO Annual Meeting abstract reported an overall objective response rate to IL-21 of 24% and median progression-free survival of 5.19 months, which will be updated with the final analysis for the oral presentation. In a historical database of other Phase 2 melanoma studies conducted by the National Cancer Institute of Canada Clinical Trials Group with similar entry criteria, median progression-free survival was 1.58 months. The objective response rate was not dependent on BRAF mutation status. The most common adverse events were fatigue, rash, diarrhea and myalgia. The IL-21 abstract is available at ASCO.org. Updated results will be presented at ASCO.
“We’re encouraged by the progression-free survival and response rate in patients with advanced melanoma,” said Eleanor L. Ramos, M.D., Senior Vice President and Chief Medical Officer of ZymoGenetics. “We selected 30µg/kg/day as the dose for further investigation and are planning a randomized Phase 2b study with the National Cancer Institute of Canada Clinical Trials Group that will seek to further validate the efficacy of IL-21 as a treatment for metastatic melanoma.”
ASCO Oral Presentation
Abstract title: Interleukin-21(IL-21) has activity in patients (pts) with metastatic melanoma (MM)
Abstract #: 8507
Presenter: Teresa Petrella, MD, MSc, FRCPC, Odette Cancer Centre, NCIC Clinical Trials Group
Date: June 5, 2010
Time: 2:00 p.m.
Place: S406 (Vista Room)
About Interleukin 21 (IL-21)
Interleukin 21 (IL-21) is a cytokine that modifies the function of cells in the immune system. IL-21 activates several types of immune cells thought to be critical in eliminating cancerous or virally infected cells from the body. Specifically, IL-21 enhances the activity of natural killer cells and has multiple effects on cytotoxic T cells. This novel immunotherapy has demonstrated antitumor activity in multiple tumor types (metastatic melanoma, renal cell cancer and non-Hodgkin's lymphoma) as a single agent and in combination with other therapies. More than 250 patients have been treated in clinical trials with IL-21. The lead indication is metastatic melanoma, where IL-21 has shown efficacy and there is no consensus standard of care.
surf1944
15 years ago
ZymoGenetics Reports First Quarter 2010 Financial Results
- Results Show Improved Financial Performance and Strengthened Financial Position -
- Pipeline Advancement and Increased RECOTHROM Market Penetration Highlighted -
Press Release Source: ZymoGenetics, Inc. On Tuesday May 4, 2010, 4:00 pm
SEATTLE--(BUSINESS WIRE)--ZymoGenetics, Inc. (NASDAQ:ZGEN - News) today reported its financial results for the quarter ended March 31, 2010. For the first quarter of 2010, the company’s net loss declined to $2.4 million, or $0.03 per share, an improvement from the $18.1 million, or $0.26 per share, reported for the first quarter of 2009. The decreased loss resulted from higher revenues as well as lower operating expenses.
“With last year’s significant changes to our strategy and operations behind us, we’re pushing forward in 2010 focused on our key assets, including randomized comparative Phase 2 studies of PEG-Interferon lambda for hepatitis C and IL-21 for cancer,” said Douglas E. Williams, Ph.D., Chief Executive Officer of ZymoGenetics. “We’re making progress toward our goals for the year and, with the capital we raised in January, we believe we have the financial resources we need to reach important milestones for all of our key assets.”
On January 12, 2010, the company completed an underwritten follow-on public offering, which resulted in net proceeds to the company of $90.8 million. As of March 31, 2010, the company had $228.3 million of cash, cash equivalents and short-term investments.
Financial Results
Revenues for the first quarter of 2010 increased to $35.5 million from $24.8 million for the first quarter of 2009. The increase was attributable to higher collaboration and license revenues and a doubling of sales of RECOTHROM® Thrombin, topical (Recombinant) in the United States.
Net sales of RECOTHROM were $9.0 million for the first quarter of 2010 compared to $4.5 million for the first quarter of 2009 and were approximately the same as U.S. net sales for the fourth quarter 2009. While both the company’s market share and hospital unit demand for the product increased in the first quarter of 2010 versus the fourth quarter of 2009, these trends were offset by a reduction in the level of wholesaler inventories.
Collaboration and license revenues were $26.2 million for the first quarter of 2010 compared to $20.0 million in the first quarter of the prior year. The increase was primarily related to recognition of revenue associated with the December 2009 license agreement with Novo Nordisk for IL-21 antagonists. Incremental revenues related to the company’s PEG-Interferon lambda collaboration with Bristol-Myers Squibb also contributed to the increase. These increases were partially offset by reduced revenues from collaborations with Bayer and Merck Serono, which ended in the fourth quarter of 2009, and from Novo Nordisk milestone payments that were earned in the first quarter of 2009 but not in the first quarter of 2010.
Costs and expenses for the first quarter of 2010 decreased to $35.6 million from $40.8 million for the first quarter of 2009. The decrease was largely attributable to expense reductions resulting from the company’s 2009 restructuring, which is expected to continue to benefit the company’s expense structure in coming quarters.
Research and development expenses for the first quarter of 2010 were $19.7 million, a decrease of $5.0 million from the first quarter of 2009. The decrease was primarily attributable to reduced employee-related costs resulting from headcount reductions made in 2009, partially offset by an increase in the company’s share of development costs from the PEG-Interferon lambda collaboration with Bristol-Myers Squibb.
Selling, general and administrative expenses for the first quarter of 2010 were $14.0 million, compared to $15.0 million for the first quarter of 2009. The decrease was primarily related to reduced employee-related costs and the discontinuation of Bayer commission expense, which is now being charged against a liability recorded in December 2009. These reductions were partially offset by increased patent and legal costs.
Business Highlights
ZymoGenetics has made substantial progress toward achieving its 2010 business objectives, as shown by the following:
Stock Offering
The company sold 16,100,000 shares of its common stock in January 2010, resulting in net proceeds of approximately $90.8 million after payment of underwriting discounts, commissions and expenses.
PEG-Interferon lambda (Phase 2)
Pharmacokinetic results for the Phase 1b PEG-Interferon lambda clinical trial were presented at the European Association for the Study of the Liver annual meeting in April 2010. The findings indicate that weekly administration of fixed doses of PEG-Interferon lambda is appropriate. That regimen is currently being evaluated in an ongoing Phase 2 clinical trial. Patient enrollment in Part A of the Phase 2 study was completed in February 2010, and enrollment in Part B of the study is expected to begin during the next several months.
RECOTHROM (Marketed product)
Hospital unit demand for RECOTHROM continued to increase in the first quarter of 2010 by approximately 14% versus the fourth quarter of 2009. The company’s estimated share in dollars of the stand-alone thrombin market increased from approximately 17% in the fourth quarter of 2009 to approximately 19% in the first quarter of 2010. Additionally, the company presented results at the American Burn Association annual meeting from a Phase 4 post-approval study that support the safety profile of RECOTHROM in pediatric patients.
Interleukin-21 (IL-21, Phase 2)
Overall survival and progression free survival data continue to be generated in the Phase 2a study of IL-21 in metastatic melanoma. Results of the study will be presented at the American Society of Clinical Oncology annual meeting on June 5, 2010 in an oral presentation. The company and its collaborator, the National Cancer Institute of Canada Clinical Trials Group, are preparing to initiate a randomized Phase 2b study of IL-21 in metastatic melanoma.
Conference Call and Webcast Information
ZymoGenetics First Quarter 2010 Financial Results Conference Call will be held on May 4, 2010 at 4:30 p.m. Eastern Time and may be accessed at http://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.zymogenetics.com&esheet=6274831&lan=en_US&anchor=www.zymogenetics.com&index=1&md5=943ced442ba838fc8a9949e434c7e531 or by dialing 1-877-407-0778 (International: 201-689-8565). Participants should dial in to the call approximately 10 minutes prior to the scheduled start time to register. A live audio webcast and slide presentation can be accessed by going to: http://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.zymogenetics.com&esheet=6274831&lan=en_US&anchor=www.zymogenetics.com&index=2&md5=96bf6cc16f3f589bb7c8cc9a4ba6a9b5. The webcast will be archived for 60 days.
For replay, please visit http://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.zymogenetics.com&esheet=6274831&lan=en_US&anchor=www.zymogenetics.com&index=3&md5=6c5128f885d27ec14a3d470ae996b05e or use the following information:
•U.S. callers: 877-660-6853
•International callers: 201-612-7415
Replay passcode account #: 286
Conference ID #: 349411
surf1944
15 years ago
ZymoGenetics to Host Conference Call and Webcast on May 4, 2010 to Discuss Q1 2010 Financial Results
Press Release Source: ZymoGenetics, Inc. On Friday April 16, 2010, 6:00 am EDT
SEATTLE--(BUSINESS WIRE)--ZymoGenetics, Inc. (NASDAQ: ZGEN - News) announced today that it will report first quarter financial results on Tuesday, May 4, 2010 after market close. Following the announcement, members of the company’s senior management will discuss the results and provide a corporate update.
Conference Call and Webcast Information
ZymoGenetics First Quarter 2010 Financial Results Conference Call will be held on May 4, 2010 at 4:30 p.m. Eastern Time and may be accessed at http://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.zymogenetics.com&esheet=6252024&lan=en_US&anchor=www.zymogenetics.com&index=1&md5=00297aa68b9de9c07f0bb584d9695b00 or by dialing (877) 407-0778 (International: 201-689-8565). Participants should dial in to the call approximately 10 minutes prior to the scheduled start time to register. A live audio webcast and slide presentation can be accessed by going to: http://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.zymogenetics.com&esheet=6252024&lan=en_US&anchor=www.zymogenetics.com&index=2&md5=1dc658d80f588ff583f8692070bdea9a. The webcast will be archived for 60 days.
For replay, please visit http://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.zymogenetics.com&esheet=6252024&lan=en_US&anchor=www.zymogenetics.com&index=3&md5=bbad1d923bf5bd734f31e5ab62da17b9 or use the following information:
•U.S. callers: (877) 660-6853
•International callers: (201) 612-7415
Replay passcode account #: 286
Conference ID #: 349411
surf1944
15 years ago
6:10AM Zymogenetics announces new publication supports safety profile of RECOTHROM thrombin, topical in numerous surgical settings (ZGEN) 5.65 : Co announces the publication of pooled safety and immunogenicity observations from eight clinical trials of RECOTHROM in the February issue of the Journal of the American College of Surgeons. The authors concluded that RECOTHROM is a well-tolerated topical hemostatic agent in numerous surgical settings and has a low rate of anti-product antibody formation. In the pooled data from all trials, less than one percent of treated patients developed product-specific antibodies. None of the antibodies neutralized native coagulation proteins. "These pooled safety data are significant, as they provide a robust clinical trial data set for a topical hemostat, The adverse events observed were consistent with those expected in the surgical populations studied, and immune response to RECOTHROM was consistently low, with no development of antibodies that neutralized native human thrombin."
surf1944
15 years ago
4:32PM Zymogenetics and Bayer restructure RECOTHROM agreements (ZGEN) 6.06 +0.05 : Co announced a restructuring of the U.S. co-promotion and ex-U.S. license and collaboration agreements with Bayer Schering Pharma AG and Bayer HealthCare relating to RECOTHROM Thrombin, topical (Recombinant). Effective January 1, 2010, co regains full promotion rights in the United States and all ex-U.S. rights except in Canada, where Bayer will market and sell the product. Under the terms of the revised agreements, active co-promotion by Bayer in the U.S. will end on December 31, 2009; Bayer will receive its normal sales commission through that date. Beginning in 2010, Bayer will receive a reduced sunset period commission through December 31, 2011, which was previously capped at $25 million per year and now will be subject to an aggregate maximum of $12 million. ZymoGenetics will no longer be required to pay Bayer U.S. sales bonus payments totaling $20 million, which were anticipated to have been payable in 2010 and 2011 or upon termination of the co-promotion agreement
surf1944
15 years ago
Bristol-Myers Squibb and ZymoGenetics Present Final Phase 1b Results for PEG-Interferon Lambda in Hepatitis C
Antiviral activity seen at all dose levels tested
Results support moving to dose-ranging Phase II studies in treatment-naïve HCV patients
Press Release
Source: Bristol-Myers Squibb Company
On 5:30 pm EDT, Saturday October 31, 2009
Companies:Bristol-Myers Squibb Co.Zymogenetics, Inc.
PRINCETON, N.J. & SEATTLE--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE: BMY - News) and ZymoGenetics, Inc. (NASDAQ: ZGEN - News) today presented final results from a Phase 1b clinical trial of PEG-Interferon lambda administered with ribavirin in relapsed and treatment-naïve hepatitis C virus (HCV) patients. The poster included data on 56 patients in the study. Antiviral activity was observed at all dose levels tested. The results will be presented at the American Association for the Study of the Liver Diseases annual meeting in Boston on November 3. Interim results were previously presented at the European Association for the Study of the Liver annual meeting in April 2009.
“There is a strong need for additional options for hepatitis C patients,” said Brian Daniels, M.D., senior vice president, Global Development & Medical Affairs, Bristol-Myers Squibb. “We are pursuing this investigational pathway to address the fact that although current interferons have been the backbone of therapy with meaningful efficacy, they are often poorly tolerated, leading to dose reductions, poor compliance and avoidance of treatment.”
“We are excited about the prospects for PEG-Interferon lambda as a potential HCV treatment,” said Eleanor L. Ramos, M.D., senior vice president and chief medical officer of ZymoGenetics. “There is a clear unmet medical need for an interferon with improved safety and tolerability. We look forward to obtaining additional clinical data on this promising investigational medicine.”
The Phase 1b clinical trial was designed to evaluate the safety and antiviral activity of PEG-Interferon lambda when given as a single agent or in combination with ribavirin in genotype 1 HCV patients with relapsed disease and in treatment-naïve patients.
In the single agent arm of the study with treatment-relapsed patients (n=24), PEG-Interferon lambda was administered subcutaneously at 1.5 mcg/kg and 3.00mcg/kg weekly for four weeks, and 1.5 mcg/kg and 3.00 mcg/kg every two weeks. In the combination arm of the study with treatment-relapsed patients (n=24), PEG-Interferon lambda was administered subcutaneously weekly at 0.5 mcg/kg, 0.75 mcg/kg, 1.5 mcg/kg and 2.25 mcg/kg for four weeks, with daily oral ribavirin administered consistent with the package insert. Patients in the cohort of treatment-naïve patients (n=7) were given 1.5 mcg/kg of PEG-Interferon lambda and ribavirin.
PEG-Interferon lambda demonstrated antiviral activity at all dose levels tested in both relapse and treatment naïve HCV patients. A majority of patients across all treatment arms achieved a greater than 2 log reduction in HCV RNA.
Of the patients in the single agent arm of the study, all 12 of those patients receiving 1.5 mcg/kg and 3.0mcg/kg weekly for four weeks achieved a greater than 2 log decrease in HCV RNA. Five of the 12 patients receiving 1.5 mcg/kg and 3.00mcg/kg every two weeks for four weeks achieved a greater than 2 log decrease in HCV RNA.
At PEG-Interferon lambda doses of 0.75 mcg/kg, 1.5 mcg/kg and 2.25 mcg/kg administered in combination with ribavirin in treatment-relapsed patients (n=18), a greater than 3 log mean maximum decrease in viral load was observed. Of those patients, eleven (61%) had less than 1,000 HCV RNA copies at Day 29.
Treatment-naive patients, who were treated with 1.5 mcg/kg of PEG-Interferon lambda in combination with ribavirin (n=7), also had a greater than 3 log mean maximum decrease in viral load and two patients (29%) achieved a rapid virologic response (RVR), or undetectable HCV RNA copies, at 4 weeks.
The most common adverse events were fatigue (29%) and nausea (13%). There were minimal effects on neutrophil counts. Minimal constitutional symptoms or hematologic effects were observed with PEG-Interferon lambda given as a single agent or in combination with ribavirin. The majority of adverse events and laboratory changes were grade 1 or 2. Dose-limiting elevations in ALT or AST, with or without an increase in bilirubin, were dose-dependent and reversible.
Overall, the results of the study support moving to dose-ranging Phase 2 studies in treatment-naïve HCV patients.
About Interferon lambda
Interferon lambda (IL-29) is a type 3 interferon that binds to a unique receptor with more restricted distribution than the receptors targeted by type 1 interferons, such as interferon alpha. It is in development for hepatitis C. The native human protein Interferon lambda is generated by the immune system in response to viral infection. IL-29 is a member of the type 3 Interferon family, which includes IL-28A and IL-28B, and signals through the same receptor as IL-28A and IL-28B.
About Bristol-Myers Squibb
Bristol-Myers Squibb is a global biopharmaceutical company committed to discovering, developing and delivering innovative medicines that help patients prevail over serious diseases. For more information, please visit www.bms.com.
GuruTrader
15 years ago
ZymoGenetics shares fall on Oppenheimer downgrade
ZymoGenetics shares fall as analyst downgrades, citing valuation and risky programs
On 10:52 am EDT, Monday October 26, 2009
Buzz up! 0 Print.Companies:ZymoGenetics, Inc.
NEW YORK (AP) -- Shares of ZymoGenetics Inc. fell Monday after an Oppenheimer analyst downgraded the stock, citing its valuation and what he called risky development programs.
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Symbol Price Change
ZGEN 5.38 -0.25
{"s" : "zgen","k" : "c10,l10,p20,t10","o" : "","j" : ""} The stock fell 32 cents, or 5.7 percent, to $5.31 in morning trading. Shares have traded between $2.06 and $6.71 over the past 52 weeks.
Oppenheimer analyst Dr. Brian Abrahams downgraded shares to "Underperform" from "Perform," saying the current stock value understates the company's risky development programs.
He expects sales of Recothrom, which is used to control bleeding during surgical procedures, to grow slowly. It is the company's only marketed product and sales reached $6 million during the second quarter. Also, he said the development of the company's hepatitis C treatment Peg-IFN lambda is complicated, while progress with the IL-21, aimed at inflammatory diseases, is unlikely next year.
"While we do not see a discrete near-term event that would drive downside, as Recothrom's modest long-term trajectory becomes more apparent and potential pipeline setbacks accrue, we would expect downside from current levels," Abrahams said in a note to investors.
In April, the company, headquartered in Seattle, said it would lay off 32 percent of its staff, or 161 employees, in a cost-cutting move. At the time, the company said it expected that move to save $30 million annually, starting in the third quarter.
surf1944
15 years ago
UPDATE 1-Zymogenetics says Merck Serono discontinues MS trials
* Says trials showed increased MS activity in one study
* Says other trials to continue
Sept 28 (Reuters) - Biotechnology firm Zymogenetics Inc (ZGEN.O) said its licensee, Merck Serono SA, discontinued trials of its experimental drug, atacicept, for the treatment of multiple sclerosis (MS).
Zymogenetics said the decision by Merck Serono, a unit of German drugmaker Merck KGaA (MRCG.DE), was based on a recommendation from an independent data monitoring panel, which observed an increase in MS disease activity in the treatment arm compared to the dummy drug in a study.
Two ongoing studies of atacicept -- to treat rheumatoid arthritis and systemic lupus erythematosus -- are continuing, as no comparable issues have been identified, the company said in a regulatory filing.
Merck Serono has the global development and marketing rights for atacicept against autoimmune diseases such as MS and rheumatoid arthritis.
Shares of Zymogenetics closed at $6.15 Friday on Nasdaq. (Reporting by Anuradha Ramanathan in Bangalore; Editing by Vinu Pilakkott
surf1944
16 years ago
ZymoGenetics and Merck Serono Restructure Partnership
Wednesday September 3, 6:00 am ET
Conference call to be held September 3, 2008 at 10:30 a.m. Eastern Time
SEATTLE--(BUSINESS WIRE)--ZymoGenetics, Inc. (NASDAQ: ZGEN - News) today announced a restructuring of its partnership with Merck Serono, a division of Merck KGaA, Darmstadt, Germany. With respect to the ongoing development of atacicept, ZymoGenetics exercised its contractual right to convert to a worldwide royalty license. By making this election, ZymoGenetics will no longer be responsible for funding development costs, and Merck Serono will fund 100% of the program costs on a worldwide basis. Merck Serono will now have exclusive worldwide development and commercialization rights for atacicept, including in North America. Merck Serono will make milestone payments to ZymoGenetics, as agreed in the original contract between the two companies signed in 2001, and pay royalties on worldwide net sales.
“We believe that atacicept holds tremendous promise as a potential treatment for autoimmune diseases, with a broad, parallel path of development in lupus, multiple sclerosis, and rheumatoid arthritis. Converting to a royalty position on atacicept allows us to avoid a major capital commitment, reduce expenses and preserve cash over the next several years, while securing the value of our atacicept asset,” said Douglas E. Williams, Ph.D., President of ZymoGenetics.
The companies also revised their research alliance to achieve greater operational efficiencies. ZymoGenetics will now control the development and commercialization of IL-31 mAb, and Merck Serono will have the full responsibility for developing and commercializing IL-17RC. Both compounds are drug candidates for the treatment of inflammatory diseases. Future product candidates resulting from the companies’ activities under the research alliance will be exclusively licensed for development and commercialization to either ZymoGenetics or Merck Serono.
“This restructuring of our partnership with ZymoGenetics emphasizes the importance of atacicept and our commitment to the program,” added Vincent Aurentz, Executive Vice President Portfolio Management & Business Development at Merck Serono. “It also demonstrates the need to be flexible in managing successful partnerships to maximize their potential. Having the responsibility for development and exclusive commercialization rights for atacicept also in North America strengthens the overall strategic value of atacicept for Merck Serono.”
Conference Call and Webcast Information
A ZymoGenetics conference call will be held on September 3, 2008 at 10:30 a.m. Eastern Time and may be accessed at www.zymogenetics.com or by dialing 877-407-0778 (International: 201-689-8565). Participants should dial in to the call approximately 10 minutes prior to the scheduled start time to register. A live webcast of the presentation can be accessed by going to: www.zymogenetics.com. The webcast will be archived for 30 days.
For replay, please visit www.zymogenetics.com or use the following information:
* U.S. callers: 877-660-6853
* International callers: 201-612-7415
Replay passcode account #: 286
Conference ID #: 296009
surf1944
16 years ago
ZymoGenetics Earns Milestone Payment for RECOTHROM(R) European Filing
Tuesday September 2, 6:00 am ET
SEATTLE--(BUSINESS WIRE)--ZymoGenetics, Inc. (NASDAQ:ZGEN - News) announced today that it will receive a $5 million milestone payment from Bayer HealthCare, which was triggered by the submission of the Marketing Authorization Application to the European Medicines Agency (EMEA) for approval to market RECOTHROM® Thrombin, topical (Recombinant). Bayer filed with the EMEA for authorization to market RECOTHROM as a topical aid to control surgical bleeding. RECOTHROM received United States Food and Drug Administration approval in January 2008.
“Bayer’s filing for approval in Europe demonstrates their commitment to RECOTHROM,” said Bruce L.A. Carter, Chief Executive Officer of ZymoGenetics. “Bayer has been a valued partner in selling RECOTHROM, the first and only plasma-free thrombin, in the US and in driving the ex-US program forward.”
RECOTHROM is being commercialized in a global collaboration between ZymoGenetics and Bayer which began in June 2007. Bayer acquired the rights to RECOTHROM in all markets outside the US and will commercialize RECOTHROM, leveraging the company’s strong commercial presence in global markets. Currently, stand-alone thrombin products are not widely available in the European Union (EU). However, in five of the largest member states of the EU there are in excess of 4 million surgical procedures performed annually where a hemostatic product is generally used. ZymoGenetics retains US market rights and Bayer provides its trained surgical sales force to support the first three years of the US market launch.
About RECOTHROM® Thrombin, topical (Recombinant)
RECOTHROM is a recombinant form of human thrombin that is structurally and functionally similar to human thrombin. It is not derived from animal or human blood. With thrombin being used in more than 1 million surgeries each year in the United States, RECOTHROM gives surgeons the opportunity to provide their patients with a plasma-free thrombin alternative for surgical hemostasis. The production of recombinant proteins is not dependent on the availability of blood from animals or human donors and can be scaled up to meet market demand.
RECOTHROM is indicated as an aid to hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible and control of bleeding by standard surgical techniques is ineffective or impractical. RECOTHROM may be used in conjunction with an absorbable gelatin sponge, USP.
surf1944
16 years ago
ZymoGenetics Reports Second Quarter 2008 Financial Results
Tuesday August 5, 4:00 pm ET
- RECOTHROM(R) 20,000-IU Vial and Spray Kit Approved by FDA -
- $100 Million Funding Commitment Secured from Deerfield Management -
SEATTLE--(BUSINESS WIRE)--ZymoGenetics, Inc. (NASDAQ:ZGEN - News) today reported its financial results for the second quarter ended June 30, 2008. The company reported a net loss for the quarter of $37.4 million, or $0.54 per share, compared to a net loss of $37.3 million, or $0.55 per share, in the prior year quarter.
“With FDA approval of the RECOTHROM® 20,000-IU vial and the spray kit co-packaged with this larger vial, we now have a full line of product presentations available for sale. This, together with contracts now in place with several large group purchasing organizations, should help to accelerate market conversion in the second half of the year,” said Bruce L.A. Carter, Ph.D., chief executive officer of ZymoGenetics. “Further, we have increased our financial strength through the $100 million funding commitment from Deerfield Management.”
ZymoGenetics reported significantly higher revenues for the second quarter of 2008 compared to the prior year quarter, primarily due to increased collaboration revenues and product sales of RECOTHROM. Overall, revenues were $12.6 million in the second quarter of 2008, compared to $4.2 million in the prior year quarter. The $8.3 million increase resulted from revenues related to the RECOTHROM collaboration with Bayer Healthcare, milestone payments related to rFactor XIII, continuing sales of the 5,000-IU vials of RECOTHROM (which was approved by the FDA in January 2008), and initial wholesaler stocking of the 20,000-IU vials and spray kits of RECOTHROM (which were approved by the FDA in May 2008). Net sales of RECOTHROM totaled $1.4 million in the second quarter.
Costs of product sales included only the costs of packaging and distributing RECOTHROM that were incurred subsequent to the initial FDA approval in January 2008. All other costs of manufacturing RECOTHROM were incurred prior to the initial FDA approval and were expensed to research and development.
Research and development expenses were $33.1 million in the second quarter of 2008, compared to $32.0 million in the prior year quarter. The increase was primarily due to incremental clinical development costs associated with atacicept. This increase was partially offset by reduced contract manufacturing expenses, as all RECOTHROM manufacturing costs are now recorded as inventory and expensed as costs of product sales when product is sold, and by reduced salary and benefit costs resulting from the company’s February 2008 restructuring.
Selling, general and administrative expenses were $16.0 million in the second quarter of 2008, a $5.8 million increase from the prior year quarter. The increase was largely related to the deployment of the RECOTHROM sales force in the second half of 2007 and marketing costs related to the U.S. launch of RECOTHROM.
Net other expense in the second quarter of 2008 was $753,000 compared to $672,000 of net other income in the second quarter of 2007. The decrease reflects lower investment income, which resulted from lower cash balances to invest and decreased interest rates.
The company ended the quarter with $116.9 million of cash, cash equivalents and short-term investments. In addition to these funds, the company received a $100 million loan commitment in June from Deerfield Management, a leading healthcare investment organization and a significant ZymoGenetics shareholder. The funds generally can be drawn in $25 million installments at any time until January 2010 at ZymoGenetics’ discretion and will be repayable five years from the date of the funding arrangement.
Business Highlights
During the second quarter and to date in the third quarter, ZymoGenetics’ product development and commercialization programs continued to advance, including the following highlights:
RECOTHROM
* Received FDA approval for, and began shipments of, RECOTHROM® Thrombin, topical (Recombinant) 20,000 international unit (IU) vial and co-packaging of the 20,000-IU vial with ZymoGenetics’ Spray Applicator Kit.
* Executed contracts with four of six key group purchasing organizations, the federal government and other hospital networks.
* Presented data from the Phase 2 spray application clinical trial in burn patients, showing that topical application of RECOTHROM using a pump spray device demonstrated a similar safety profile and rate of antibody formation to that observed in the RECOTHROM Phase 3 clinical trial.
Atacicept
* ZymoGenetics and Merck Serono began patient treatment in the Phase 2/3 general systemic lupus erythematosus clinical trial.
* ZymoGenetics and Merck Serono initiated Phase 2 clinical trials evaluating the safety and efficacy of atacicept in patients with relapsing multiple sclerosis and in patients with optic neuritis.
IL-21
* Completed patient enrollment in a Phase 2 study in combination with Nexavar® (sorafenib) tablets in renal cell carcinoma patients.
PEG-Interferon lambda
* Completed enrollment of the second patient cohort and began enrollment of the third cohort in a Phase 1b study evaluating safety, tolerability and antiviral activity in chronic genotype-1 hepatitis C patients who have relapsed after prior therapy.
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