Gilead Sciences (GILD) 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 VALENCE).
Japanese HCV Market Offers Huge Commercial Potential
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 throughout 2014.
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.
AbbVie (ABBV) and Bristol-Myers Squibb Company (BMY) are also aiming to bring all-oral HCV combination therapies to the market.
Gilead carries a Zacks Rank #3 (Hold). A better-ranked stock in the biopharma space is Regeneron Pharmaceuticals (REGN), sporting a Zacks Rank #1 (Strong Buy).