Thursday, January 20, 2011

Telaprevir "Gets FDA Priority Review" In U.S. and Canada/Jan 20

UPDATE 1-Vertex Pharma's Hep C drug gets priority review

"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."

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

Vertex says FDA will rule on telaprevir by May 23
CAMBRIDGE, Mass. (AP) — Vertex Pharmaceuticals Inc. said Thursday that regulators in the U.S. and Canada will speed their reviews of its drug candidate telaprevir, meaning the hepatitis C therapy could be approved months earlier than usual.
Vertex said the Food and Drug Administration will do a six-month priority review on telaprevir, meaning the agency expects to make a decision by May 23. Typical FDA reviews last about 10 months, starting from the date the drug maker files for approval.
The Therapeutic Product Directorate of Health Canada will take six to nine months to make its decision on telaprevir, Vertex said. Standard reviews in Canada take about a year and a half.
Telaprevir is already receiving an accelerated review in Europe. Analysts believe Vertex could get billions of dollars in annual revenue from telaprevir, the first in what could be a series of new treatments for hepatitis C.
Telaprevir and Merck & Co.'s drug boceprevir are more effective than older therapies in controlling the viral liver disease.

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