Daclatasvir data demonstrates potential to address high unmet needs, including cirrhotic and treatment-experienced patients, and those with genotypes 1, 2, 3 and 4
Breadth of viral hepatitis data underscores Company’s commitment to advancing research of liver diseases
Monday, March 24, 2014 5:39 am EDT
"The wealth of data we are sharing at the International Liver Congress continue the positive momentum for daclatasvir after the Marketing Authorization Application was validated for Accelerated Regulatory Review by the European Medicines Agency, highlighting the important potential role for daclatasvir-based regimens in Europe."
PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) announced today that 12 abstracts have been accepted for presentation at The International Liver CongressTM, the 49th annual meeting of the European Association for the Study of the Liver (EASL), in London, April 9 – 13.
Key presentations include:
- Two sets of pivotal results from a global, Phase III study (HALLMARK DUAL) investigating the efficacy and safety of an all-oral, interferon- and ribavirin-free regimen of daclatasvir and asunaprevir, including data in cirrhotic and non-cirrhotic patients with HCV genotype 1b infection, will be presented as late-breakers.
- Virologic response results from analyses investigating daclatasvir in combination with sofosbuvir across genotypes 1, 2 and 3.
- Virologic response and safety data for the investigational all-oral 3DAA regimen (daclatasvir/asunaprevir/BMS-791325) in genotype 4 patients, as well as bioequivalence data for the daclatasvir 3DAA regimen, which is being studied as a fixed-dose-combination treatment with twice daily dosing.
“These results are encouraging and show the potential of daclatasvir across multiple treatment regimens, with the goal of helping patients achieve cure regardless of genotype, stage of disease or response to previous therapies,” said Brian Daniels, MD, senior vice president, Global Development and Medical Affairs, Research and Development, Bristol-Myers Squibb. “The wealth of data we are sharing at the International Liver Congress continue the positive momentum for daclatasvir after the Marketing Authorization Application was validated for Accelerated Regulatory Review by the European Medicines Agency, highlighting the important potential role for daclatasvir-based regimens in Europe.”
Bristol-Myers Squibb is studying a broad portfolio of compounds in hopes of providing flexible treatment options to address the diverse unmet medical needs of a global HCV patient population. These investigational compounds include daclatasvir, an investigational NS5A replication complex inhibitor that has shown high antiviral potency and pan-genotypic activity across HCV genotypes in vitro; asunaprevir, an investigational NS3 protease inhibitor; BMS-791325, an investigational non-nucleoside inhibitor of the NS5B polymerase; and peginterferon lambda-1a (Lambda), an investigational type III interferon that has the potential to offer an alternative to alfa-interferon.
The complete list of Bristol-Myers Squibb data presentations is below. Abstracts can be accessed on the ILC/EASL website at http://www.ilc-congress.eu.
Title Date/Time Hepatitis C: Direct-Acting Antiviral Data
Oral Presentation (late-breaker): All-oral dual therapy with daclatasvir and asunaprevir in patients with HCV genotype 1b infection: Phase 3 study results -- April 12, 15:30 - 17:30
Poster (late-breaker): Efficacy and safety of daclatasvir in combination with asunaprevir (DCV+ASV) in cirrhotic and non-cirrhotic patients with HCV genotype 1b: Results of the HALLMARK DUAL study -- April 10, 09:00 - April 12, 18:00
Oral Presentation: Effect of baseline NS5A polymorphisms on virologic response to the all-oral combination of daclatasvir + sofosbuvir ± ribavirin in patients with chronic HCV infection -- April 11, 16:00 - 18:00
Poster: Effect of ribavirin on the safety profile of daclatasvir + sofosbuvir for patients with chronic HCV infection -- April 12, 09:00 - 18:00
Poster: All-oral therapy with daclatasvir in combination with asunaprevir and BMS-791325 for treatment-naive patients with chronic HCV genotype 4 infection -- April 12, 09:00 - 18:00
Poster: Daclatasvir, asunaprevir, and BMS-791325 in a fixed-dose combination: A phase 1 bioavailability study in healthy volunteers -- April 12, 09:00 - 18:00
Hepatitis B: Peginterferon Lambda-1a Data
Poster: Peginterferon Lambda-1a pharmacokinetics in subjects with impaired renal function -- April 12, 09:00 - 18:00
Oral: Peginterferon Lambda for the treatment of chronic hepatitis B (CHB): A phase 2b comparison with peginterferon alfa in patients with HBeAg-positive disease -- April 12, 15:30 - 17:30
Hepatitis C: Global Health Economics and Outcomes Research (GHEOR)
Oral Presentation: External validation of the risk-prediction model for hepatocellular carcinoma (HCC) from the REVEAL-HCV study using data from the U.S. Veterans Affairs (VA) health system -- April 10, 16:00 - 18:00
Poster: The impact of fibrosis on the risk of long-term morbidity and mortality in chronic hepatitis C patients treated in the veterans administration health care system -- April 11, 09:00 - 18:00
Poster: Early virologic responses and adverse events from the comparative assessment of effectiveness of antiviral therapies in hepatitis C study (CMPASS) -- April 12, 09:00 - 18:00
Poster: Determining the comparative effectiveness of emerging treatment regimens for hepatitis C virus (HCV) infection from single arm phase III trials -- April 12, 09:00 - 18:00
About Hepatitis C
Hepatitis C is a virus that infects the liver and is transmitted through direct contact with infected blood and blood products. Up to 90 percent of those infected with hepatitis C will not spontaneously clear the virus and will become chronically infected. According to the World Health Organization, up to 20 percent of people with chronic hepatitis C will develop cirrhosis; of those, up to 25 percent may progress to liver cancer. In the European Union (EU) an estimated 9 million people are living with hepatitis C, and an estimated 170 million people worldwide are infected with the virus.
About Bristol-Myers Squibb’s HCV Portfolio
Bristol-Myers Squibb’s research efforts are focused on advancing late-stage compounds to deliver the most value to patients with hepatitis C. At the core of our pipeline is daclatasvir (DCV), an investigational NS5A replication complex inhibitor that has been studied in more than 5,500 patients as part of multiple direct-acting antiviral (DAA) based combination therapies. DCV has shown a low drug-drug interaction profile, supporting its potential use in multiple treatment regimens and in people with co-morbidities.
In 2014, the U.S. Food and Drug Administration (FDA) granted Bristol-Myers Squibb’s investigational DCV Dual Regimen (daclatasvir and asunaprevir) Breakthrough Therapy Designation for use as a combination therapy in the treatment of genotype 1b HCV infection.
In 2013, Bristol-Myers Squibb’s investigational all-oral 3DAA Regimen (daclatasvir/asunaprevir/BMS-791325) also received Breakthrough Therapy Designation, which helped to expedite the start of the ongoing Phase III UNITY Program. Study populations include non-cirrhotic naïve, cirrhotic naïve and previously treated patients. The daclatasvir 3DAA regimen is being studied as a fixed-dose-combination treatment with twice daily dosing.
Daclatasvir is also being investigated in combination with sofosbuvir in high unmet need patients, such as pre- and post-transplant patients, HIV/HCV co-infected patients, and patients with genotype 3, as part of the ongoing Phase III ALLY Program.
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 clinical trials of these compounds will support regulatory filings, or that DCV or any other compounds mentioned in this release will receive regulatory approval 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, 2013 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.
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