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Vertex Pharma Says Health Canada Okays INCIVEK For People With Hepatitis C

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8/22/2011 8:19 AM ET

Vertex Pharmaceuticals Inc. (VRTX: Quote) Monday said Health Canada has approved INCIVEK, or telaprevir, tablets for people with genotype 1 chronic hepatitis C with compensated liver disease, including cirrhosis.

INCIVEK is approved for use in combination with pegylated-interferon and ribavirin, two other medicines approved to treat hepatitis C. It is indicated for people who are new to treatment, and for people who were treated previously but who did not achieve a sustained viral response.

According to Vertex, the drug is approved for use in all three major groups of people who did not achieve a viral cure despite prior treatment including relapsers, partial responders and null responders. The drug has been shown to help clear the virus for nearly four out of five patients new to treatment.

Hepatitis C affects about a quarter of a million Canadians and until recently, around 40 percent of people who underwent a year of treatment for hepatitis C were cured.

INCIVEK is given as two 375-mg tablets, three times daily. It is given for 12 weeks in combination with pegylated-interferon and ribavirin, after which patients stop receiving INCIVEK and continue treatment with pegylated-interferon and ribavirin for an additional 12 weeks or 36 weeks of treatment.

With INCIVEK combination treatment, over 60 percent of people treated for the first time, and those who relapsed after previous therapy, are expected to complete all treatment in 24 weeks, which is half the time needed if they were to take pegylated-interferon and ribavirin alone. Rash and anemia are the most serious side effects associated with INCIVEK.

The approval was based on data from three Phase 3 studies of more than 2,500 people with hepatitis C. The studies showed that people who received INCIVEK combination treatment achieved significantly higher rates of viral cure compared to those who received pegylated-interferon and ribavirin alone, irrespective of their prior treatment experience.

Robert Kauffman, Senior Vice President and Chief Medical Officer for Vertex, said, "INCIVEK's ability to nearly double that rate of cure and cut treatment time in half for the majority of patients being treated for the first time marks a turning point in the fight against this disease."

VRTX closed Friday's regular trade at $46.49, compared to the prior close of $45.29, on 2.28 million shares.

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by RTT Staff Writer

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