Bristol-Myers Squibb Company
) announced that it has submitted a New Drug Application (NDA) to
the pharmaceutical and medical devices agency of Japan seeking
approval to market its combination therapy of daclatasvir and
asunaprevir ( an all-oral, interferon and ribavirin-free regimen)
for treating patients suffering from hepatitis C virus (HCV).
Bristol-Myers noted that interferon-based therapies are the
current standard of care for treating HCV patients. While
daclatasvir belongs to a new class of drugs- NS5A inhibitors-
asunaprevir is a NS3 protease inhibitor.
Approval was sought on the basis of encouraging data from a phase
III study which showed that the combination of daclatasvir and
asunaprevir achieved an overall sustained virologic response of
84.7% after 24 weeks of treatment in Japanese patients suffering
from genotype 1b version of HCV. The patients were either
ineligible for or intolerant to interferon therapy or
non-responders to the same.
Bristol-Myers stated in its press release that for the first time
an approval has been sought for an interferon-free and ribavirin
-free therapy to cure HCV. A 48-week course of both
peg-interferon (peg-INF - weekly injections) and ribavirin, are
the standard treatment for genotype 1 HCV infection. However,
this treatment regimen is associated with significant
side-effects like fatigue, flu-like symptoms, etc.
Consequently, the HCV market is highly lucrative across the
globe. Bristol-Myers stated that in Japan alone 1.2 million
people are estimated to be affected by HCV. The company also said
that approximately 70% of the HCV affected population suffers
from genotype 1b of the infection.
Many companies are developing all-oral combination therapies
targeting the lucrative HCV market.
Gilead Sciences, Inc
) sofosbuvir (in combination with ribavirin) is a high-potential
candidate (under review) targeting HCV. A decision from the U.S.
Food and Drug Administration is expected by Dec 8, 2013. An
advisory panel of the FDA recommended the approval of sofosbuvir
Bristol-Myers carries a Zacks Rank #3 (Hold).
) appears to be more attractive with a Zacks Rank #1 (Strong
Johnson & Johnson
) also appears to be well placed with a Zacks Rank #2 (Buy).
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