January 20, 2011

Vertex Pharma's Hep C drug gets priority review

Thu Jan 20, 2011 8:08am EST

* Drug gets priority review status from FDA, Health Canada
* FDA sets action date for May 23

Jan 20 (Reuters) - Vertex Pharmaceuticals Inc (VRTX.O) said its experimental treatment for Hepatitis C got priority review status from health regulators in the United States and Canada.

Cambridge, Massachusetts-based Vertex, which had asked the U.S. Food and Drug Administration for a priority review of data from telaprevir in November, said the agency set an action date for May 23 to decide on the approval.

Priority review status from the FDA reduces the review period by four month, the company said. The same status from Canadian health regulator Health Canada cuts short the review period to six to nine months, compared to a review period of 18 months or more.

Vertex is developing telaprevir in collaboration with Tibotec Pharmaceuticals, a unit of Johnson & Johnson (JNJ.N), and Mitsubishi Tanabe Pharma (4508.T).

Vertex holds rights to market the drug in North America while Tibotec has rights to market it in Europe, South America, Australia, the Middle East and certain other countries. Mitsubishi Tanabe has rights in Japan and certain Far East countries.

Shares of Vertex have risen 15 percent since it applied for the priority review. They closed at $39.45 Wednesday on Nasdaq. (Reporting by Vidya L Nathan in Bangalore)

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Also See: U.S. FDA and Health Canada Grant Priority Reviews for Telaprevir for the Treatment of Hepatitis C

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