|[July 07, 2014]
Japan Approves First All-Oral, Interferon- and Ribavirin-Free Hepatitis C Treatment, Daklinza® (daclatasvir) and Sunvepra® (asunaprevir) Dual Regimen
PRINCETON, N.J. --(Business Wire)--
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
compensaed cirrhosis: (1) patients who are ineligible or intolerant to
interferon-based therapy, and (2) patients who have failed to respond to
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
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
na�ve, cirrhotic na�ve 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
or follow us on Twitter (News - Alert) 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.
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