Bristol-Myers
Squibb Company (NYSE:BMY) today announced that the Committee for
Medicinal Products for Human Use (CHMP) of the European Medicines Agency
(EMA) has adopted a positive opinion recommending that Daklinza®
(daclatasvir), an investigational, potent pan-genotypic NS5A complex
inhibitor (in vitro), be granted approval for use in combination
with other medicinal products for the treatment of chronic hepatitis C
virus (HCV) infection in adults. This is the first positive opinion
given by the CHMP for an NS5A complex inhibitor and will now be reviewed
by the European Commission, which has the authority to approve medicines
for the European Union (EU).
“Through Bristol-Myers Squibb’s Early Access Programs in Europe more
than 2,000 HCV patients with advanced liver disease have already been
treated with Daklinza, in combination with sofosbuvir,” said
Elliott Levy, Head of Specialty Development, Bristol-Myers Squibb. “We
anticipate that, if approved, Daklinza-based regimens will play a
significant role in treating HCV patients with high unmet medical needs
across Europe.”
Recently included in the European Association for the Study of the
Liver’s (EASL) clinical practice guidelines for the management of HCV
infection across genotypes, the EU marketing authorization application
for Daklinza has gone through an accelerated review
process. The positive CHMP opinion was based on data from multiple
studies of Daklinza with other HCV agents, including sofosbuvir,
for the treatment of chronic hepatitis C.
Applications for Daklinza-based regimens are also pending in
Japan and the U.S. A decision from Japan’s Pharmaceutical and Medical
Devices Agency is expected soon, and the U.S. Food and Drug
Administration has granted priority review status and set a target
review date under the Prescription Drug User Fee Act (PDUFA) of November
30, 2014.
Ongoing and completed Daklinza studies have included more than
5,500 patients in a variety of all-oral regimens and with the current
interferon-based standard of care. Across clinical studies, Daklinza-based
regimens have been generally well tolerated with low rates of
discontinuations across a range of patients.
About Hepatitis C
Globally, there are 150 million people infected with HCV and of that, an
estimated 9 million people are living with hepatitis C in the European
Union (EU). 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, 20 percent of people with
chronic hepatitis C will develop cirrhosis and, of those, about 5 to 7
percent of patients may ultimately die of the consequences of infection.
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, an
investigational, potent pan-genotypic NS5A complex inhibitor (in vitro),
which continues to be investigated in multiple treatment regimens and in
people with co-morbidities.
Daclatasvir is being studied 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.
In 2014, the U.S. Food and Drug Administration (FDA) granted
Bristol-Myers Squibb’s investigational Daclatasvir Dual Regimen
(daclatasvir + 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 in the U.S., 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.
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 daclatasvir 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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