Bristol-Myers Squibb to Present New Data Demonstrating Company’s Continuing Commitment to Research and Development in Liver Disease at The American Association for the Study of Liver Diseases (AASLD) Annual Meeting

  • Late breaker oral presentation will feature first report of SVR4 results from an interferon- and ribavirin-free, 12-week, triple DAA, investigational regimen of daclatasvir, asunaprevir and BMS-791325 in hepatitis C (HCV)
  • Oral presentations on HCV investigational compounds daclatasvir, asunaprevir and peginterferon lambda-1a (Lambda) demonstrate diversity of portfolio
  • Late breaker poster presentations will report Phase II data on Lambda in the treatment of HCV and chronic hepatitis B
Tuesday, October 16, 2012 11:28 am EDT

Dateline:

PRINCETON, N.J.

Public Company Information:

NYSE:
BMY
"Bristol-Myers Squibb has a long-term commitment to viral hepatitis and has been at the forefront of the evolving science in both hepatitis B and C, where there remains considerable unmet medical need"

PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) announced today that 27 abstracts on the Company’s research in liver disease have been accepted for presentation at The Liver Meeting® 2012, the 63rd annual meeting of The American Association for the Study of Liver Diseases (AASLD), in Boston, November 9 – 13.

Bristol-Myers Squibb is studying a portfolio of compounds with the potential to address unmet medical needs for patients with liver disease, including the investigational compounds daclatasvir, asunaprevir, Lambda and BMS-791325 being studied in hepatitis C (HCV), Lambda being studied in hepatitis B (HBV), and BARACLUDE® (entecavir). BARACLUDE is currently indicated for the treatment of chronic hepatitis B in adults with evidence of active viral replication and either evidence of persistent elevations in aminotransferases (ALT or AST), or histologically active disease.

Key presentations include:

  • A late breaker oral presentation of SVR4 results with an interferon- and ribavirin (RBV)-free, 12-week regimen of daclatasvir, asunaprevir and BMS-791325 in a Phase II study of treatment-naïve patients with chronic HCV genotype 1
  • An oral presentation of SVR12 results with a regimen of daclatasvir and asunaprevir, with or without alfa interferon (alfa)/RBV, in a Phase II study of chronic HCV genotype 1 null responders
  • A late breaker oral presentation on the first report of SVR4 results from 12-week treatment arms of a Phase II study of daclatasvir and GS-7977, with or without RBV, in treatment-naïve patients with chronic HCV genotype 1, 2 or 3
  • A late breaker poster presentation on SVR12 results from the D-LITE Phase II study of Lambda in combination with RBV and either daclatasvir or asunaprevir in patients with chronic HCV genotype 1
  • A late breaker poster presentation on Lambda versus alfa in a Phase II study of patients with chronic hepatitis B

“Bristol-Myers Squibb has a long-term commitment to viral hepatitis and has been at the forefront of the evolving science in both hepatitis B and C, where there remains considerable unmet medical need,” said Brian Daniels, MD, senior vice president, Global Development and Medical Affairs, Research and Development, Bristol-Myers Squibb. “In hepatitis C, we believe improving treatment outcomes requires a personalized approach to meet the needs of the diverse patient population. The data we are presenting at AASLD help expand our understanding of the potential efficacy and safety profiles of our investigational hepatitis C compounds and support our ongoing Phase III development programs.”

The Company will also show three presentations of outcomes research/real-world data that add to the understanding of the prevalence of and current treatment patterns in HBV, HCV and hepatocellular carcinoma (HCC).

The complete list of Bristol-Myers Squibb data presentations is below. Abstracts can be accessed on the AASLD website at http://aasld2012.abstractcentral.com/.

Title   Date/Time
Chronic Hepatitis B: BARACLUDE (entecavir) Clinical Data

Entecavir + Adefovir Versus Lamivudine + Adefovir Or Entecavir Alone In
Lamivudine-Resistant Chronic Hepatitis B: 96-Week Data From The
DEFINE Study

 

November 10,
2:00 – 7:30 p.m.

Antiviral Efficacy of Entecavir in Black/African American and Hispanic
patients with Chronic Hepatitis B who are nucleos(t)ide-naïve

 

November 10,
2:00 – 7:30 p.m.

Randomized, observational study of long-term entecavir treatment versus
other standard of care nucleos(t)ide analog therapy in nucleos(t)ide-naïve
patients with chronic hepatitis B from a ‘real-world’ clinical practice setting
in China

 

November 10,
2:00 – 7:30 p.m.

Disease and Treatment Perceptions Among Asian Americans Diagnosed
with Chronic Hepatitis B Infection

 

November 10,
2:00 – 7:30 p.m.

Hepatitis C: Direct-Acting Antiviral Data

Sustained Virologic Response in Chronic HCV Genotype (GT) 1-Infected
Null Responders With Combination of Daclatasvir (DCV; NS5A Inhibitor)
and Asunaprevir (ASV; NS3 Inhibitor) With or Without Peginterferon Alfa-
2a/Ribavirin (PEG/RBV)

 

November 11,
4:45 – 5:00 p.m.

First Ever Successful Use of Daclatasvir and GS-7977, an Interferon-Free
Oral Regimen, in a Liver Transplant Recipient with Severe Recurrent
Hepatitis C

 

November 10,
2:00 – 7:30 p.m.

Comparison of Pre-Existing and Emerging Resistance-Associated Variants
in US, EU and Japanese HCV Genotype 1b Prior Interferon Alfa (IFN-α)
Non Responders and IFN-α Ineligible Patients Treated with Daclatasvir and
Asunaprevir

 

November 11,
8:00 a.m. – 5:30 p.m.

Characterization of HCV NS5A Resistance Variants in Naive Patients
Infected with Genotypes 2 and 3 Receiving Short-Term Treatment of
Daclatasvir in Combination with Pegylated Interferon-Alfa and Ribavirin

 

November 11,
8:00 a.m. – 5:30 p.m.

Characterization of HCV Genotype 1 NS5A Resistance Variants From the
Phase 2b COMMAND-1 Study: Daclatasvir Plus Peginterferon-alfa
/ribavirin in Treatment-naive Patients

 

November 11,
8:00 a.m. – 5:30 p.m.

Twelve- or 16-Week Treatment With Daclatasvir Combined With
Peginterferon Alfa and Ribavirin for Hepatitis C Virus Genotype 2 or 3
Infection: Command GT2/3 Study

 

November 11,
8:00 a.m. – 5:30 p.m.

Daclatasvir, an NS5A Replication Complex Inhibitor, Combined With
Peginterferon Alfa-2a and Ribavirin in Treatment-Naive HCV-Genotype 1
or 4 Subjects: Phase 2b COMMAND-1 SVR12 Results

 

November 11,
8:00 a.m. – 5:30 p.m.

High Rate of Sustained Virologic Response with the All-Oral Combination
of Daclatasvir (NS5A Inhibitor) Plus Sofosbuvir (Nucleotide NS5B
inhibitor), With or Without Ribavirin, in Treatment-Naïve Patients
Chronically Infected With HCV Genotype 1, 2, or 3

 

November 12,
3:15 – 3:30 p.m.

An Interferon-free, Ribavirin-free 12-Week Regimen of Daclatasvir (DCV),
Asunaprevir (ASV), and BMS-791325 Yielded SVR4 of 94% in Treatment-
Naïve Patients with Genotype (GT) 1 Chronic Hepatitis C Virus (HCV)
Infection

 

November 12,
3:30 – 3:45 p.m.

Asunaprevir in Japanese Subjects in Phase 2: Exposure-Safety Versus
US/EU-Based Subjects and Preliminary Assessment of Correlation with
Single Nucleotide Polymorphisms (SNPs) in Liver Uptake Transporters

 

November 13,
8:00 a.m. – Noon

Effect of Hepatic Impairment on the Pharmacokinetics of
Asunaprevir (BMS-650032, ASV)

 

November 13,
8:00 a.m. – Noon

Hepatitis C and B: PEG-Interferon Lambda Data

Peginterferon Lambda-1a (Lambda) is less likely to induce clinically
significant neuropsychiatric symptoms during the treatment of chronic
hepatitis C virus (HCV) infection, compared to Peginterferon alfa-2a (Alfa)

 

November 11,
8:00 a.m. – 5:30 p.m.

Peginterferon Lambda-1a (Lambda) is Associated With Less Autoimmune
Thyroid Disease and Serious Autoimmune Disease Than Peginterferon Alfa-
2a (Alfa) When Used in Combination With Ribavirin (RBV) for the
Treatment of Chronic Hepatitis C Virus Infection

 

November 11,
8:00 a.m. – 5:30 p.m.

Peginterferon Lambda, a New Potential Therapeutic Option for the
Treatment of Chronic Hepatitis B: A Phase 2B Comparison with
Peginterferon Alfa in Patients with HBeAg-Positive Disease

 

November 12,
8:00 a.m. – 5:30 p.m.

 

Sustained Virologic Response (SVR12) in HCV Genotype 1 Patients
Receiving Peginterferon Lambda in Combination With Ribavirin and
Either Daclatasvir or Asunaprevir: Interim Results From the D-LITE Study

 

November 12,
8:00 a.m. – 5:30 p.m.

 

Peginterferon Lambda–1a (Lambda) Compared to Peginterferon Alfa–2a
(Alfa) in Treatment–Naïve Patients With HCV Genotypes (GT) 1 or 4:
SVR24 Results From EMERGE Phase 2b

 

November 13,
8:45 – 9:00 a.m.

First Report of Peginterferon Lambda/Ribavirin in Combination With Either
Daclatasvir or Asunaprevir in HCV Genotype 1 Japanese Subjects: Early
Sustained Virologic Response (SVR4) Results From the D-LITE Japanese
Sub-Study

 

November 13,
Noon – 12:15 p.m.

Baseline CXCR3 Ligand Levels are Associated With Early Virologic
Response to Treatment With Peginterferon Lambda-1a in Chronic
Hepatitis C Patients in a Phase 2b Study

 

November 13,
8:00 a.m. – Noon

Pegylated Interferons Lambda-1a and Alfa-2a Display Different Gene
Induction and Cytokine Release Profiles in Both Human Hepatocytes and
Peripheral Blood Mononuclear Cells

 

November 13,
8:00 a.m. – Noon

Hepatitis C: Outcomes Research / Real-World Data

Genome-Wide Association Study to Identify Potential Single Nucleotide
Polymorphisms Associated with Hepatocellular Carcinoma among Chronic
Hepatitis C Patients

 

November 11,
8:00 a.m. – 5:30 p.m.

Reasons for Treatment (Tx) Discontinuation Among Hepatitis C (HCV)
Patients Treated in Clinical Practice

 

November 13,
8:00 a.m.- Noon

Hepatocellular Carcinoma: Brivanib Data

Brivanib (BRI) versus Sorafenib (SOR) as First-line Therapy in Patients
with Unresectable, Advanced Hepatocellular Carcinoma (HCC): Results
from the Phase 3 BRISK-FL Study

 

November 12,
4:15 – 4:30 p.m.

Hepatocellular Carcinoma: Outcomes Research

Observations of Hepatocellular Carcinoma (HCC) Management Patterns
from the Global HCC BRIDGE Study: Global Comparison of Outcomes by
Locoregional Therapy

 

November 13,
8:00 a.m. – Noon

INDICATION and IMPORTANT SAFETY INFORMATION about BARACLUDE (entecavir) 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 (entecavir):

  • 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.
  • Virologic, biochemical, serologic, and safety data are available from a controlled study in adult subjects with chronic HBV infection and decompensated liver disease.
  • 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 BARACLUDE (entecavir) is 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 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 (entecavir) 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, 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 (entecavir) 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 entecavir 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 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 (entecavir) 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.
  • The safety and efficacy of BARACLUDE in liver transplant recipients are unknown. 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 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.

Additional Information

BARACLUDE is not a cure for HBV. Patients should be advised that treatment with BARACLUDE has not been shown to reduce the risk of transmission of HBV to others through sexual contact or blood contamination.

Please see accompanying Full Prescribing Information, including Boxed WARNINGS, or click 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.

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

Contact:

Bristol-Myers Squibb
Media:
Cristi Barnett, 609-252-6028
cristi.barnett@bms.com
or
Investors:
John Elicker, 609-252-4611
john.elicker@bms.com

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