October 01, 2010 02:16 PM Eastern Daylight Time
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New Data on Multiple Bristol-Myers Squibb Compounds to be Presented at AASLD 2010
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PRINCETON, N.J.--(BUSINESS WIRE)--New data on multiple Bristol-Myers Squibb Company (NYSE:BMY) compounds will be presented at the 61st annual meeting of the American Association for the Study of Liver Diseases (AASLD) in Boston from October 29 to November 2.
Data will be presented on BARACLUDE® (entecavir) in patients with chronic hepatitis B, and on compounds in clinical development for the treatment of hepatitis C, using multiple scientific approaches to target the hepatitis C virus (HCV). Key hepatitis C presentations include data on novel combinations of investigational agents, including BMS-790052, a NS5A inhibitor, and BMS-650032, an NS3 inhibitor. Additionally, 12-week Phase 2a data on PEG-Interferon lambda, a novel type 3 interferon with enhanced specificity for hepatocyte binding, will be presented.
The Company will also present outcomes research data in both hepatitis C and hepatocellular carcinoma.
“Bristol-Myers Squibb is focused on developing innovative medicines to treat liver disease,” said Elliott Sigal, M.D., Ph.D., executive vice president, chief scientific officer and president, Research and Development, Bristol-Myers Squibb. “Building on our established expertise in viral hepatitis and oncology, the data at this year’s Liver Meeting demonstrates the breadth and strength of our hepatitis C portfolio. We are pursuing multiple targets with the potential to be used in combination regimens to advance the treatment of this serious disease.”
BARACLUDE, BMS-790052, and BMS-650032 were discovered by Bristol-Myers Squibb Research and Development. PEG-Interferon lambda was discovered by ZymoGenetics, Inc. Bristol-Myers Squibb and ZymoGenetics announced a global collaboration for PEG-Interferon lambda and its related development program in 2009. In September 2010, Bristol-Myers Squibb announced its intent to acquire ZymoGenetics.
The Bristol-Myers Squibb data presentations at AASLD are as follows:
Date/Time Presentation Title Lead Author
Hepatitis B
October 30
2:00 - 7:30 p.m. Efficacy and Safety of Entecavir in Nucleos(t)ide Naive Asians with HBeAg Positive and Negative Chronic Hepatitis B: Results from Studies ETV-022/027 (Abstract #485) R. Gish
California Pacific Medical Center
San Francisco,
California
October 30
2:00 - 7:30 p.m. Long-term Entecavir Treatment for up to 5 Years in Asians with HBeAg- Positive Nucleos(t)ide Naïve Chronic Hepatitis B: Results from ETV-022 and -901 (Abstract #478) C. Pan
Mount Sinai School of Medicine
New York, New York
Hepatitis C
October 31, 8:00 – 5:30 p.m. Pegylated Interferon Lambda (PEG-IFN-λ) Phase 2 Dose-Ranging, Active-Controlled Study in Combination with Ribavirin (RBV) for Treatment-Naïve HCV Patients (Genotypes 1, 2, 3 or 4): Safety Viral Response, and Impact of IL-28B Host Genotype through Week 12 (Abstract #821)
A.J. Muir
Duke University School of Medicine
Durham, North Carolina
October 31, 8:00 – 5:30 p.m. Co-administration of BMS-790052 and BMS-650032 Does Not Result in a Clinically Meaningful Pharmacokinetic Interaction in Healthy Subjects (Abstract #827) M. Bifano
Bristol-Myers Squibb
October 31, 8:00 – 5:30 p.m. Pharmacokinetics of PEG-Interferon Lambda (PEG-IFN-λ) Following Fixed Dosing in Treatment-Naïve Hepatitis C Subjects (Single Dose Interim Data from a Dose-Ranging Phase 2a Study) (Abstract #830) K.A. Byrnes-Blake
ZymoGenetics
October 31, 8:00 – 5:30 p.m. The Effect of Treatment Group, HCV Genotype, and IL-28B Genotype on Early HCV Viral Kinetics in a Phase 2a Study of PEG-Interferon Lambda (PEG-IFN-λ) in Hepatitis C Patients (Abstract #831) J.A. Freeman
ZymoGenetics
November 1, 8:00 a.m. – 5:30 p.m. Combination therapy with BMS-790052 and BMS-650032 alone or with pegIFN/RBV results in undetectable HCV RNA through 12 weeks of therapy in HCV genotype 1 null responders (Abstract # LB-8) A. S. Lok
University of Michigan
Ann Arbor, Michigan
November 2, 7:00 a.m. – 12:00 p.m. Genotypic and Phenotypic Analysis of HCV NS5A Inhibitor Resistance Variants: Correlations Between In Vitro and In Vivo Observations (Abstract #1853) M. Gao
Bristol-Myers Squibb
November 2, 7:00 a.m. – 12:00 p.m. In Vitro Activity of the Combination of Pegylated Interferon-Lambda with Direct-Acting Antivirals in the HCV Replicon Model (Abstract #1854) F. McPhee
Bristol-Myers Squibb
November 2, 7:00 a.m. – 12:00 p.m. BMS-824393 is a Potent Hepatitis C Virus NS5A Inhibitor with Substantial Antiviral Activity When Given as Monotherapy in Subjects with Chronic Genotype 1 HCV Infection (Abstract #1858) R. Nettles
Bristol-Myers Squibb
November 2, 7:00 a.m. – 12:00 p.m. BMS-790052, a First-in-Class Potent Hepatitis C Virus NS5A Inhibitor, Demonstrates Multiple-Dose Proof-of-Concept in Subjects with Chronic Genotype 1 HCV Infection (Abstract #1881) R. Nettles
Bristol-Myers Squibb
November 2, 7:00 a.m. – 12:00 p.m. Chronic Hepatitis C Infections and the Risk of Depression and Other Adverse Events (Abstract #1895) J. McCombs
University of Southern California
Los Angeles, California
November 2, 7:00 a.m. – 12:00 p.m. The impact of hepatitis C on health-related quality of life, work productivity, and healthcare utilization (Abstract #1942) M. daCosta DiBonaventura
Kantar Health
New York, New York
Hepatocellular Carcinoma
November 2, 7:00 a.m. – 12:00 p.m. Treatment of Hepatocellular Carcinoma (HCC) in Two Major Tertiary Care Centers in the United States (US) (Abstract #1846) M. Schwartz
Mt. Sinai
New York, New York
About Bristol-Myers Squibb
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information, please visit http://www.bms.comor/ follow us on Twitter at http://twitter.com/bmsnews .
Full prescribing information for BARACLUDE is available at www.bms.com.
Forward-Looking Statements
This press release contains "forward-looking statements" relating to the acquisition of ZymoGenetics by Bristol-Myers Squibb. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Among other risks, there can be no guarantee that the acquisition will be completed, or if it is completed, that it will close within the anticipated time period. Forward-looking statements in the press release should be evaluated together with the many uncertainties that affect Bristol-Myers Squibb's business, particularly those identified in the cautionary factors discussion in Bristol-Myers Squibb's Annual Report on Form 10-K for the year ended December 31, 2009, its Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K. Bristol-Myers Squibb undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise.
Except for the historical information presented herein, matters discussed herein may constitute forward-looking statements that are subject to certain risks and uncertainties that could cause actual results to differ materially from any future results, performance or achievements expressed or implied by such statements. Statements that are not historical facts, including statements preceded by, followed by, or that include the words “future”; “anticipate”; “potential”; “believe”; or similar statements are forward-looking statements. Risks and uncertainties include uncertainties as to the timing of the tender offer and merger; uncertainties as to how many of the ZymoGenetics shareholders will tender their shares in the offer; the risk that competing offers will be made; the possibility that various closing conditions for the transaction may not be satisfied or waived, including that a governmental entity may prohibit, delay or refuse to grant approval for the consummation of the transaction; the effects of disruption from the transaction making it more difficult to maintain relationships with employees, licensees, other business partners or governmental entities; as well as risks detailed from time to time in ZymoGenetics’ public disclosure filings with the SEC, including its Annual Report on Form 10-K for the fiscal year ended December 31, 2009, subsequent quarterly filings on Form 10-Q and the Solicitation/Recommendation Statement filed in connection with the tender offer. The information contained in this release is as of September 28, 2010.
This press release is neither an offer to purchase nor a solicitation of an offer to sell shares of ZymoGenetics. Bristol-Myers Squibb Company and Zeus Acquisition Corporation have filed a tender offer statement with the SEC, and have mailed an offer to purchase, forms of letter or transmittal and related documents to ZymoGenetics shareholders. ZymoGenetics has filed with the SEC, and has mailed to ZymoGenetics shareholders a solicitation/recommendation statement on Schedule 14D-9. These documents contain important information about the tender offer and stockholders of ZymoGenetics are urged to read them carefully when they become available.
These documents will be available at no charge at the SEC's website at http://www.sec.gov/ . The tender offer statement and the related materials may be obtained for free by directing a request by mail to Georgeson Inc., 199 Water Street, 26th Floor, New York, New York 10038 or by calling toll-free (800) 491-3096. In addition, a copy of the offer to purchase, letter or transmittal and certain other related tender offer documents (once they become available) may also be obtained free of charge from Bristol-Myers Squibb by directing a request to: Public Affairs, Telephone No.: (609) 252-6579; E-Mail: jennifer.mauer@bms.com
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