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Bristol-Myers Gains Japanese Approval for HCV Combo Drug

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Bristol-Myers Squibb Company (BMY) 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.

Gilead Sciences (GILD) 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 side effects.

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 Actelion (ALIOF) and Biogen Idec (BIIB). Both are Zacks Ranked #1 (Strong Buy) stocks.

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