Bristol-Myers Squibb Company
) received encouraging news when the Japanese Ministry of Health,
Labour and Welfare (MHLW) cleared its combination therapy of
Daklinza (daclatasvir) and Sunvepra (asunaprevir) for treating
patients suffering from the genotype 1 strain of chronic hepatitis
C virus (HCV), including those affected by compensated cirrhosis.
While Daklinza is a NS5A replication complex inhibitor, Sunvepra is
a NS3/4A protease inhibitor.
Approval was gained on the basis of encouraging data from a phase
III study which showed that the combination of Daklinza and
Sunvepra 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 had sought Japanese approval for the dual regimen
late last year.
Bristol-Myers stated in its press release that this marked the
first interferon-free and ribavirin-free therapy to be approved in
Japan for treating HCV. The biopharmaceutical major further noted
that interferon-based therapies are the current standard of care
for treating HCV patients.
) intends to seek Japanese approval of a fixed dose combination of
ledipasvir and its highly successful HCV treatment Sovaldi in
genotype 1 patients by year end.
The HCV market is highly lucrative worldwide. Japan particularly
offers significant commercial potential making us highly bullish on
the approval. As per Bristol-Myers, in Japan alone 1.2 million
people are estimated to be affected by HCV. The company further
stated that approximately 70% of the HCV affected population suffer
from genotype 1b of the infection. Moreover, people aged over 65
years form a significant portion of the HCV affected population in
Japan. It decreases the probability of elderly patients tolerating
interferon-based medications, which are associated with serious
Bristol-Myers is looking to get Daklinza-based regimens approved in
the U.S. (target date: Nov 30, 2014) and EU (under review) for
treating HCV. We expect investor focus to remain on updates
regarding the development of Bristol-Myers' HCV pipeline.
Bristol-Myers carries a Zacks Rank #3 (Hold). Better-ranked
stocks in the healthcare sector include
). Both are Zacks Ranked #1 (Strong Buy) stocks.
Want the latest recommendations from Zacks Investment Research?
Today, you can download 7 Best Stocks for the Next 30 Days.
Click to get this free report
BRISTOL-MYERS (BMY): Free Stock Analysis Report
GILEAD SCIENCES (GILD): Free Stock Analysis
ACTELION LTD (ALIOF): Get Free Report
BIOGEN IDEC INC (BIIB): Free Stock Analysis
To read this article on Zacks.com click here.