Good news flowed in at
Bristol-Myers Squibb Company
) from Europe with the European Commission (EC) approving the
biopharmaceutical company's Daklinza as a combination therapy for
treating adults infected with genotypes 1, 2, 3 and 4 of chronic
hepatitis C virus (HCV). Bristol-Myers stated in its press release
that following the EC move Daklinza became the first NS5A complex
inhibitor to gain approval in the EU.
The EC approval does not surprise us since the European Medicines
Agency's (EMA) Committee for Medicinal Products for Human Use
(CHMP) had backed the approval of the cocktail therapy earlier in
the year. Approval of Daklinza in the EU has brought down the
duration of HCV treatment to either 12 or 24 weeks from 48 weeks
associated with interferon- and ribavirin-based regimens.
Following the clearance, Daklinza can be used in combination with
other drugs including Gilead Sciences' (
) high-flying HCV treatment Sovaldi. The combination of Daklinza
and Sovaldi performed exceedingly well in clinical trials. The
combination can be used to treat various types of HCV patients
including those with advanced liver disease, genotype 3 and those
who have not responded to treatment with protease inhibitors.
Daklinza in combination with Sunvepra received Japanese approval in
July for treating patients suffering from the genotype 1 strain of
HCV. Bristol-Myers is also looking to get Daklinza-based regimens
approved in the U.S. (target date: Nov 30, 2014). Gilead's HCV
combination therapy of Sovaldi and ledipasvir is expected to be
approved in the U.S. earlier (target date: Oct 10, 2014). AbbVie (
) is also looking to bring its HCV combination therapy into the
market. We expect investor focus to remain on updates related to
HCV combination therapies going forward.
Bristol-Myers carries a Zacks Rank #3 (Hold). A better-ranked stock
in the biopharma space is Celgene Corporation (
) holding a Zacks Rank #2 (Buy).
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