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
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.
Bristol-Myers Squibb CompanyMedia:Jeff Smith,Office:
+33(0)1 58 83 83 21; Cell: +33(0) 6 03 99 40
18jr.smith.paeurope@bms.comorCarrie Fernandez,Office:
+1-609-252-4831; Cell:
+1-215-859-2605carrie.fernandez@bms.comorJulie Ferguson,Office:
+1-609-252-5597; Cell:
+1-312-385-0098julie.ferguson@bms.comorInvestors:Ranya
Dajani, 609-252-5330, ranya.dajani@bms.comRyan Asay, 609-252-5020,
ryan.asay@bms.com
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