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Bristol-Myers Squibb To Present Range Of New Hepatitis C Data At The 2013 American Association For The Study Of Liver Diseases (AASLD) Annual Meeting

Stocks in this article: BMY

Please replace the release with the following corrected version due to multiple revisions.

The corrected release reads:

Bristol-Myers Squibb to Present Range of New Hepatitis C Data at the 2013 American Association for the Study of Liver Diseases (AASLD) Annual Meeting

  • Phase III SVR 24 data on daclatasvir + asunaprevir, an investigational, interferon-free and ribavirin-free treatment regimen, in Japanese HCV patients with high unmet needs selected to lead off this year’s Presidential Plenary session
  • Data presentations provide further insight on dosing, tolerability and safety of multiple daclatasvir-based investigational HCV regimens
  • 16 accepted abstracts on HCV and HBV underscore the breadth of the company’s hepatitis portfolio

Bristol-Myers Squibb Company (NYSE:BMY) announced today that 16 abstracts have been accepted for presentation at The Liver Meeting ® 2013, the 64th Annual Meeting of The American Association for the Study of Liver Diseases (AASLD), in Washington D.C., November 1 – 5. These abstracts include new data supporting the company’s broad pipeline of hepatitis C (HCV) compounds.

Key presentations include:

  • Results from a Phase III study of an all-oral combination of daclatasvir (DCV) and asunaprevir (ASV) in Japanese HCV genotype 1b patients who are either ineligible or intolerant to interferon-based therapies or who are non-responders to both interferon and ribavirin. This is the first presentation of a Phase III study evaluating an all-oral, interferon-free and ribavirin-free regimen. Presentation of complete SVR 24 results from this study will lead the Viral Hepatitis Presidential Plenary session on Tuesday, November 5.
  • Additional dosing, safety and efficacy data on DCV, ASV and BMS-791325, several BMS investigational HCV compounds that are being studied as a fixed-dose combination.
  • Findings from health economics and outcomes research studies including long-term morbidity and mortality in chronic hepatitis C patients in the U.S. Veterans Health Administration; and an analysis of the burden of alfa-interferon based therapies on chronic hepatitis C patients in Japan.

“The wealth of Bristol-Myers Squibb data at this year’s AASLD meeting reflects our long-standing commitment to researching the unmet medical needs of patients with hepatitis C. We are particularly excited about our investigational, all-oral regimen of daclatasvir and asunaprevir and its potential for HCV patients, including many in Japan who currently have no treatment options,” said Brian Daniels, MD, senior vice president, Global Development and Medical Affairs, Research and Development, Bristol-Myers Squibb. “Just 25 years after the discovery of the hepatitis C virus, the HCV research community is on the cusp of a cure for more patients than ever before. Bristol-Myers Squibb is proud to be among the companies standing at the forefront of this major shift in the treatment paradigm.”

Bristol-Myers Squibb is studying a broad portfolio of new compounds in hopes of providing flexible treatment options which aim to help address the diverse unmet medical needs of a global HCV patient population. These investigational compounds include DCV, ASV, BMS-791325, and peginterferon lambda-1a (Lambda). The company also continues to study the full potential of Baraclude ® (entecavir), an oral antiviral agent with selective activity against HBV. Baraclude is a leading treatment for chronic hepatitis B and is approved in more than 90 countries.

The complete list of Bristol-Myers Squibb data presentations is below. Abstracts can be accessed on the AASLD website at www.aasld.org/livermeeting.

Title     Date/Time
Hepatitis C: Direct-Acting Antiviral Data      
Presidential Plenary: All-oral Combination of Daclatasvir plus Asunaprevir in Interferon Ineligible Naive/Intolerant and Nonresponder Japanese Patients Chronically Infected with HCV Genotype 1b: Results from a Phase III Trial     Tuesday, November 5,

8 – 8:15 a.m.

Asunaprevir Pharmacokinetics and Safety in Subjects With Impaired Renal Function     Saturday, November 2,

5:30 p.m. – 7:00 p.m.

Lack of Pharmacokinetic Interaction Between the HCV Protease Inhibitor MK-5172 and HCV NS5A Inhibitor Daclatasvir In Normal Healthy Volunteers
No Clinically-Relevant Interactions Between Asunaprevir and Selective Serotonin Reuptake Inhibitors (Escitalopram and Sertraline) in Healthy Subjects      
Daclatasvir Pharmacokinetics in Healthy Subjects: No Clinically-Significant Drug-Drug Interactions with Cyclosporine or Tacrolimus Sunday, November 3,

12:30 p.m. – 2 p.m.

Analysis of HCV Resistance Variants in a Phase III Trial of Daclatasvir Combined With Asunaprevir for Japanese Patients with Genotype 1b Infection
Safety and Efficacy of BMS-791325, a Non-Nucleoside NS5B Polymerase Inhibitor, Combined with Peginterferon Alfa-2a and Ribavirin in Treatment-Naïve Patients Infected with Hepatitis C Virus Genotype 1    
Hepatitis C and B: PEG-Interferon Lambda Data      
Inverse Modulation in Hepatic Expression of Interferon Receptor Complexes for Alpha and Lambda during HCV Infection are Associated with Altered Interferon Signaling Induction upon Treatment with Peginterferon Alfa-2a Compared to Peginterferon Lambda-1a     Saturday, November 2,

5:30 p.m. – 7 p.m.

Safety Profile of Peginterferon Lambda for Treatment of Chronic Hepatitis B Virus (HBV) or Chronic Hepatitis C Virus (HCV) Infection: Cross-Study Analysis of Patients Treated in Three Phase 2 Studies     Sunday, November 3,

12:30 p.m. – 2 p.m.

Hepatitis C: Outcomes Research / Real-World Data      
Impact of Treatment on Long-Term Morbidity and Mortality in Chronic Hepatitis C Patients Receiving Care Through the U.S. Veterans Health Administration     Tuesday, November 5,

12:30 p.m. – 12:45 p.m.

Using Laboratory Data to Predict Long-Term Morbidity and Mortality in Chronic Hepatitis C Patients Through The U.S. Veterans Health Administration Tuesday, November 5,

10:30 a.m. – 12 p.m.

Patient Burden of Peginterferon Alfa (Alfa)-Based Therapy Among Patients with Chronic Hepatitis C Infection in Japan: Report from a 2013 National Survey Study
The Comparative Effectiveness of Daclatasvir Plus Asunaprevir vs Telaprevir Triple Therapy in Nonresponder Japanese Patients Chronically Infected With HCV Genotype 1b: Results from a Bayesian Meta-Analysis
A Meta-Analysis Platform for the Continuous Updating of Knowledge Regarding Treatment Regimens for Hepatitis C Virus Infection    
Chronic Hepatitis B: BARACLUDE (entecavir) Clinical Data      
The Safety and Efficacy of Entecavir and Tenofovir Combination Therapy for Chronic Hepatitis B in Patients with Previous Nucleos(t)ide Treatment Failure Sunday, Nov. 3,

8 a.m. – 5:30 p.m.

Entecavir Pharmacokinetics Among Nucleos/tide-Naїve Pediatric Subjects    
 

About Bristol-Myers Squibb’s Commitment to Liver Disease

Bristol-Myers Squibb’s hepatitis C pipeline includes compounds with different mechanisms of action, pursuing both biologics as well as small molecule direct-acting antivirals. These compounds are being studied as part of multiple treatment regimens with the goal of increasing SVR rates across diverse patient types and geographies.

  • Our investigational NS5A replication complex inhibitor daclatasvir (DCV) has been extensively studied in thousands of patients to date as a foundational agent for multiple DAA-based combination therapies and is currently in Phase III development. DCV has shown antiviral potency and pan-genotypic activity across HCV genotypes in vitro. DCV has a drug-drug interaction profile that supports its continued study in a variety of HCV combination regimens
  • Asunaprevir (ASV) is an NS3 protease inhibitor in Phase III development for hepatitis C as a component of DCV-based treatment regimens
  • BMS-791325 is a non-nucleoside inhibitor of the NS5B polymerase, currently in Phase II development for hepatitis C as a component of DCV-based treatment regimens
  • Lambda is an investigational type III interferon that has the potential to offer an alternative to alfa-interferon in patients for whom an interferon-based regimen is required or preferred

About Hepatitis C

Hepatitis C is a virus that infects the liver and is transmitted through direct contact with infected blood and blood products. An estimated 170 million people worldwide are infected with hepatitis C, with genotype 1 being the most prevalent genotype. Up to 90 percent of those infected with hepatitis C will not clear the virus and will become chronically infected. According to the World Health Organization, 20 percent of people with chronic hepatitis C will develop cirrhosis and, of those, up to 25 percent may progress to liver cancer. In Japan, the hepatitis C virus is the most common cause of chronic hepatitis and cirrhosis, and approximately 1.2 million people there are living with the hepatitis C virus.

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