Bristol-Myers Squibb Company ( BMY ) 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 .'s ( GILD ) 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 last month.
Bristol-Myers carries a Zacks Rank #3 (Hold). Actelion Ltd . ( ALIOF ) appears to be more attractive with a Zacks Rank #1 (Strong Buy). Johnson & Johnson ( JNJ ) also appears to be well placed with a Zacks Rank #2 (Buy).