Bristol-Myers Seeks Japanese Approval - Analyst Blog

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).


BRISTOL-MYERS (BMY): Free Stock Analysis Report

GILEAD SCIENCES (GILD): Free Stock Analysis Report

JOHNSON & JOHNS (JNJ): Free Stock Analysis Report

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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