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Vertex Pharma's Telaprevir Accepted For Priority Review In Canada, U.S.

Vertex Pharmaceuticals Inc.(VRTX), Thursday said its new drug application and submission of telaprevir for hepatitis C has been accepted by the U.S. Food and Drug Administration as well as the Therapeutic Product Directorate of Health Canada. The drug candidate has been accorded priority review status by both the agencies, which nearly halves the time to process the application.

The Cambridge, Massachusetts-headquartered company said the FDA provided a target review date of May 23, 2011. Telaprevir is Vertex Pharma's lead drug in development for subjects with genotype 1 chronic hepatitis C. The molecule has been accepted for accelerated assessment in Europe by the European Medicines Agency in December 2010.

The data supporting the submissions come from three studies, ADVANCE, ILLUMINATE and REALIZE. These studies evaluated up to 12 weeks of telaprevir in combination with Pegasys and Copegus in subjects chronically infected with genotype 1 hepatitis C virus. The study group included subjects new to treatment as well as those who were treated before with currently available drugs but did not achieve a sustained viral response.

Results demonstrated up to 75 percent of people new to treatment achieved a viral cure with telaprevir-based therapy. The time to course completion was also much quicker than with currently available medicines. Those patients who had not achieved viral cure with a prior treatment course of currently available medicines had demonstrated three to five times higher cure rates. The results of the studies were announced in late November.

Vertex is developing telaprevir in collaboration with Tibotec BVBA and Mitsubishi Tanabe Pharma, and has rights to commercialize telaprevir in North America. Its affiliate, Janssen-Cilag International NV has rights to commercialize telaprevir in Europe, South America, Australia, the Middle East and certain other countries.

Hepatitis C is a serious liver disease caused by the hepatitis C virus. According to studies, approximately 60 percent of genotype 1 patients who undergo an initial 48-week regimen with pegylated-interferon and ribavirin, the currently approved medicines, do not achieve SVR or viral cure.

Up to 3.9 million people in the United States and about 250,000 people in Canada have chronic hepatitis C.

VRTX is currently trading at $40.06, up $0.61 or 1.55% on the Nasdaq. Over the past year, the stock traded in a range of $31.25 - $43.94.

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