Offers new treatment option for genotype 1
HCV patients in Japan who are interferon-ineligible/intolerant, or
did not previously respond to treatment
Japanese HCV patients in urgent need of care
now have opportunity for cure, including older patients and those
with compensated cirrhosis
Bristol-Myers Squibb Company (NYSE:BMY) announced today that the
Japanese Ministry of Health, Labor and Welfare (MHLW) has approved
Daklinza® (daclatasvir), a potent, pan-genotypic NS5A replication
complex inhibitor (in vitro), and Sunvepra® (asunaprevir), a NS3/4A
protease inhibitor, providing a new treatment that can lead to cure
for many patients in Japan who currently have no treatment options.
The Daklinza+Sunvepra Dual Regimen is Japan’s first all-oral,
interferon- and ribavirin-free treatment regimen for patients with
genotype 1 chronic hepatitis C virus (HCV) infection, including
those with compensated cirrhosis.
“Japan has a unique hepatitis C patient population, many of whom
are older and have been unable to take, or respond to, traditional
therapies, so we have a real sense of urgency to treat these
patients now,” said a lead study investigator Kazuaki Chayama of
Hiroshima University in Japan. “The approval of the
Daklinza+Sunvepra Dual Regimen offers for the first time a
treatment option that addresses many of the unmet needs for our HCV
patients.”
Of the 1.2 million people living with HCV in Japan,
approximately 70% have genotype 1b. Further, a significant number
of patients with HCV in Japan are over the age of 65, leading to
more disease-related complications and a decreased likelihood of
tolerating interferon-based therapies, the historical standard of
care for treating HCV.
“The approval of Daklinza+Sunvepra in Japan reflects our
strategic focus on developing a treatment option that meets the
needs of the Japanese HCV patient population,” said Lamberto
Andreotti, chief executive officer, Bristol-Myers Squibb. “This
milestone underscores the company’s commitment to delivering
innovative medicines to patients with the highest unmet needs, and
we believe Daklinza-based regimens will play a significant role in
the evolution of HCV treatment for patients in Japan, and
globally.”
The Daklinza+Sunvepra Dual Regimen
The indications for Daklinza and Sunvepra in Japan are for the
improvement of viraemia in either of the following patients with
chronic hepatitis C genotype 1, or chronic hepatitis C genotype 1
with compensated cirrhosis: (1) patients who are ineligible or
intolerant to interferon-based therapy, and (2) patients who have
failed to respond to interferon-based therapy.
The approval is supported by results from a Phase III study
demonstrating that the 24-week regimen of Daklinza and Sunvepra
achieved overall SVR24 (sustained virologic response 24 weeks after
the end of treatment; a functional cure) among 84.7% of Japanese
HCV patients with genotype 1b. Among patients 65 years of age or
older who were either interferon-ineligible or intolerant, 91.9%
achieved SVR24. Further, patients with compensated cirrhosis
present at baseline had overall SVR24 rates of 90.9%.
The regimen used in the Phase III study resulted in low rates of
discontinuation (5%) due to adverse events (AEs). In addition, the
rate of serious adverse events (SAEs) was low (5.9%) and few SAEs
were experienced by more than one patient. Nasopharyngitis was the
most common AE in the study (30.2%).
Results from the HALLMARK-Dual study, the Phase III
multinational clinical trial investigating the Daklinza+Sunvepra
Dual Regimen among genotype 1b HCV patients, demonstrated similar
results to the Japan registration study and support filings in
countries that have a high prevalence of genotype 1b, such as Korea
and Taiwan.
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, a potent
pan-genotypic NS5A complex inhibitor (in vitro), which continues to
be investigated in multiple treatment regimens and in people with
co-morbidities, and is undergoing regulatory review in the U.S. and
Europe.
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+Asunaprevir Dual
Regimen 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 Hepatitis C
Globally, there are 150 million people infected with HCV, with
genotype 1 being the most prevalent. 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
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 asunaprevir or any other compounds mentioned in
this release will receive regulatory approval in other countries or
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 SquibbMedia:Carrie Fernandez,
609-252-4831cell:
215-859-2605carrie.fernandez@bms.comorInvestors:Ranya
Dajani, 609-252-5330ranya.dajani@bms.comorRyan Asay,
609-252-5020ryan.asay@bms.com
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