Bristol-Myers Seeks Daclatasvir Approval in the U.S.

Bristol-Myers Squibb Company BMY announced that it has resubmitted the new drug application (NDA) for hepatitis C virus (HCV) candidate, daclatasvir, to the FDA. Bristol-Myers is looking to get daclatasvir approved for use in combination with Gilead Sciences’ GILD Solvaldi (sofosbuvir) for the treatment of chronic HCV genotype 3. A final decision from the FDA is expected by September this year.

We note that daclatasvir is already approved in Europe (in Aug 2014) for use in combination with other medicinal products across genotypes 1, 2, 3 and 4 for the treatment of chronic HCV infection in adults.

However, in the U.S., Bristol-Myers received a setback last year when the FDA issued a complete response letter for the NDA for daclatasvir. Bristol-Myers was looking to get daclatasvir approved for treatment of HCV in combination with other agents. At that time, the FDA had asked for additional data on daclatasvir in combination with other antiviral agents for the treatment of HCV.

Our Take

We are pleased with the pipeline progress at Bristol-Myers. We believe that there is a fair chance of the daclatasvir and Sovaldi combination gaining approval given the encouraging data from the phase III ALLY-3 study announced in February this year. In the study, the combination treatment regimen demonstrated high cure rates with sustained virologic response 12 weeks after treatment in 90% of treatment-naïve and 86% of treatment-experienced genotype 3 HCV patients. As per company sources, genotype 3 is estimated to affect 54.3 million people worldwide.

However, we note that several companies including AbbVie Inc. ABBV and Gilead have launched new drugs in the highly lucrative HCV market.

Bristol-Myers currently carries a Zacks Rank #3 (Hold). Cytokinetics, Incorporated CYTK is a better-ranked stock in the health care sector carrying a Zacks Rank #1 (Strong Buy).

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