Bristol-Myers Squibb to Present Range of New Hepatitis C Data at the 2013 American Association for t

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

PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol-Myers Squibb Company (NYS: 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-oralcombination 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 SVR24 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.

INDICATION and IMPORTANT SAFETY INFORMATION about BARACLUDE (entecavir) 0.5mg/1mg Tablets:

INDICATION

BARACLUDE (entecavir) is indicated for the treatment of chronic hepatitis B virus (HBV) infection in adults with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease.

The following points should be considered when initiating BARACLUDE:

1. This indication is based on histologic, virologic, biochemical, and serologic responses in nucleoside-treatment-naïve and lamivudine-resistant adult subjects with HBeAg-positive or HBeAg-negative chronic HBV infection and compensated liver disease.

2. Virologic, biochemical, serologic, and safety data are available from a controlled study in adult subjects with chronic HBV infection and decompensated liver disease.

3. Virologic, biochemical, serologic, and safety data are available for a limited number of adult subjects with HIV/HBV co-infection who have received prior lamivudine therapy.

IMPORTANT SAFETY INFORMATION

WARNINGS: SEVERE ACUTE EXACERBATIONS OF HEPATITIS B, PATIENTS CO-INFECTED WITH HIV AND HBV, and LACTIC ACIDOSIS AND HEPATOMEGALY

Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued anti-hepatitis B therapy, including entecavir. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue anti-hepatitis B therapy. If appropriate, initiation of anti-hepatitis B therapy may be warranted.

Limited clinical experience suggests there is a potential for the development of resistance to HIV (human immunodeficiency virus) nucleoside reverse transcriptase inhibitors if BARACLUDEis used to treat chronic HBV infection in patients with HIV infection that is not being treated. Therapy with BARACLUDE is not recommended for HIV/HBV co-infected patients who are not also receiving highly active antiretroviral therapy (HAART).

Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues, alone or in combination with antiretrovirals.

Warnings and Precautions

• Before initiating BARACLUDE (entecavir) therapy, HIV antibody testing should be offered to all patients. BARACLUDE has not been studied as a treatment for HIV infection and is not recommended for this use.

• Lactic acidosis with BARACLUDE use has been reported, often in association with hepatic decompensation, other serious medical conditions, or drug exposures. Patients with decompensated liver disease may be at higher risk for lactic acidosis. BARACLUDE should be suspended in any patient who develops clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity.

Adverse Reactions

• In clinical trials in patients with compensated liver disease, the most common (≥3%) adverse reactions of any severity with at least a possible relation to study drug for BARACLUDE-treated subjects were headache, fatigue, dizziness, and nausea. In these trials, the most common adverse reactions of moderate to severe intensity (grades 2-4) were diarrhea, dyspepsia, nausea, vomiting, fatigue, headache, dizziness, somnolence, and insomnia.

• In the decompensated liver disease trial, the most common adverse reactions of any severity among patients treated with BARACLUDE (entecavir), regardless of causality, included: peripheral edema (16%), ascites (15%), pyrexia (14%), hepatic encephalopathy (10%), and upper respiratory infection (10%). In this trial, 18% (18/102) of BARACLUDE patients and 20% (18/89) of adefovir patients died during the first 48 weeks of therapy. The majority of those deaths were due to liver related causes.

Drug Interactions

BARACLUDE is primarily eliminated by the kidneys, therefore coadministration of BARACLUDE with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of either BARACLUDE or the coadministered drug. Patients should be monitored closely when receiving BARACLUDE with other renally-eliminated drugs.

Pregnancy and Nursing Mothers

• There are no adequate and well-controlled studies of BARACLUDE (entecavir) in pregnant women. BARACLUDE should be used during pregnancy only if clearly needed and after careful consideration of the risks and benefits.

• There are no studies on the effect of BARACLUDE on transmission of HBV from mother to infant. Therefore, appropriate interventions should be used to prevent neonatal acquisition of HBV.

• It is not known whether BARACLUDE is excreted into human milk; however, many drugs are excreted into breast milk. Due to the potential for serious adverse reactions in nursing infants from BARACLUDE, risks and benefits should be considered when deciding whether to discontinue breast-feeding or discontinue BARACLUDE in nursing women.

Pediatric Use

• Safety and effectiveness of BARACLUDE in pediatric patients below the age of 16 years have not been established.

Renal Impairment

• Dosage adjustment of BARACLUDE is recommended for patients with a creatinine clearance <50 mL/min, including those on hemodialysis or continuous ambulatory peritoneal dialysis.

Liver Transplant Recipients

• Renal function must be carefully monitored both before and during treatment with BARACLUDE in a liver transplant recipient who has received or is receiving an immunosuppressant that may affect renal function, such as cyclosporine or tacrolimus.

Dosage and Administration

BARACLUDE (entecavir) should be administered on an empty stomach (at least 2 hours after a meal and at least 2 hours before the next meal).

The recommended dose of BARACLUDE:

• in nucleoside-naïve adults and adolescents (16+ yrs) with compensated liver disease is 0.5 mg once daily

• in adults and adolescents (16+ yrs) with compensated liver disease, and refractory to lamivudine or with known lamivudine or telbivudine resistance mutations (rtM204I/V with or without rtL180M, rtL80I/V, or rtV173L) is 1 mg once daily

• in adults with decompensated liver disease is 1 mg once daily

The optimal duration of treatment with BARACLUDE (entecavir) for patients with chronic HBV infection and the relationship between treatment and long-term outcomes such as cirrhosis and hepatocellular carcinoma are unknown.

Abbreviated Boxed WARNINGS:

Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued anti-hepatitis B therapy, including BARACLUDE. In such patients, closely monitor hepatic function (clinical and laboratory) for at least several months and, if appropriate, initiate anti-hepatitis B therapy.

Therapy with BARACLUDE is not recommended for HIV/HBV co-infected patients who are not also receiving highly active antiretroviral therapy due to the potential for development of HIV resistance to nucleoside reverse transcriptase inhibitors.

Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues.

To see additional and detailed Important Safety Information, including Boxed WARNINGSclick here.

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.com or follow us on Twitter at http://twitter.com/bmsnews.

Bristol-Myers Squibb Forward Looking Statement

This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding the research, development and commercialization of pharmaceutical products. 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 clinical trials of these compounds will support regulatory filings, or that the compounds described in this release will receive regulatory approvals or, if approved, that they will become commercially successful products. Forward-looking statements in this 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, 2012, in our Quarterly Reports on Form 10-Q and our 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.

BARACLUDE ® (entecavir) is a registered trademark of Bristol-Myers Squibb Company



Bristol-Myers Squibb
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