High Stakes Intrigue In Hep C: Bristol-Myers Vs. Gilead

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Investment Commentary 

High Stakes Intrigue In Hep C: Bristol-Myers Vs. Gilead
Jan. 22, 2014 3:47 PM ET 

Peter Geschek

Gilead's (GILD) reluctance to marry its Hep C drug Sovaldi with Bristol-Myers Squibb's (BMY) daclatasvir forced Bristol to take evasive action.

Bristol applied to the European Union for approval of daclatasvir, an investigational NS5A complex inhibitor, for the treatment of adults with chronic hepatitis C with compensated liver disease, including genotypes 1, 2, 3, and 4. The application seeks the approval of daclatasvir for use in combination with other agents, including Sovaldi.

The EU accepted the application for an accelerated regulatory review. Hepatitis C represents a high unmet need in Europe where an estimated 9 million people are living with hepatitis C.

The EU submission follows a filing in Japan seeking approval for the treatment of patients infected with HCV genotype 1b.

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An article in the January New England Journal of Medicine presents great results from the combination trial of Sovaldi and daclatasvir.

Initially 44 previously untreated patients with genotype 1, 2 and 3 were tested with daclatasvir at a dose of 60 mg once daily tablet plus Sovaldi at a dose of 400 mg once daily tablet, with or without ribavirin, for 24 weeks.

Later on the study was expanded to include 123 additional patients with Genotype 1 infection. 82 patients were previously untreated and 41 patients had been previously treated with Incivek (made by Vertex (VRTX)) or Victrelis (made by Merck (MRK)) plus peginterferon alfa and ribavirin. The primary end point was a sustained virologic response (an HCV RNA level of lower than 25 IU per milliliter) at week 12 after the end of therapy.

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