) is looking to boost the sales potential of its highly successful
drug Sovaldi (sofosbuvir) further by getting it approved in Japan.
To that end, the biopharmaceutical company filed a New Drug
Application (NDA) with Japan's Pharmaceutical and Medical Devices
Agency (PMDA) for Sovaldi for treating patients with chronic
genotype 2 hepatitis C virus (HCV) infection. Approval has been
sought for a 12-week dose of Sovaldi in combination with ribavirin.
Approval of the all-oral, interferon free regimen has been sought
primarily on the basis of positive results from a phase III study
(GS-US-334-0118). The NDA also includes data from four
international phase III studies (FISSION, FUSION, POSITRON and
Japanese HCV Market Offers Huge Commercial
Approval of the regimen in Japan would be a huge positive since the
country is believed to have one of the highest rates of liver
cancer in any industrialized nation - the blame primarily lying on
HCV - as stated by Gilead in its press release.
The market for chronic HCV is huge with more than a million people
suffering from the disease. Gilead stated further that 20% to 30%
of the patients chronically infected with HCV in Japan have the
genotype 2 strain of the virus. Currently available
treatments for the virus in Japan involve 24-48 weeks of injections
with pegylated interferon. However, this mode of treatment is
associated with serious side effects. Sovaldi will be the first
Gilead product to be launched in Japan, in the event of the PMDA
issuing a favorable decision.
Sovaldi is already available in the U.S., the EU and Canada. The
drug performed exceptionally well in the first quarter of 2014. The
HCV treatment recorded sales of $2.27 billion in its first full
quarter in the market. Sovaldi sales are expected to be strong
Gilead Looking to Get Another HCV Therapy Approved
Buoyed by the stupendous success of Sovaldi, Gilead is looking to
bring its next HCV treatment, a fixed dose combination of
ledipasvir and Sovaldi, into the market. The cocktail therapy is
under review in the U.S. for treating chronic genotype 1 HCV
patients. The FDA will decide on the approval status of the
combination treatment by Oct 10, 2014. Japanese approval for the
combination would be sought for treating genotype 1 HCV patients by
Dec 31, 2014 on the basis of positive data from a phase III study
(GS-US-337-0113). We note that the most common HCV strain in Japan
is genotype 1.
Bristol-Myers Squibb Company
) are also aiming to bring all-oral HCV combination therapies to
Gilead carries a Zacks Rank #3 (Hold). A better-ranked stock in the
biopharma space is
), sporting a Zacks Rank #1 (Strong Buy).
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