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Vertex Announces Key 2012 Business Objectives as Company Prepares for Planned Global Launch of KALYDECO in Cystic Fibrosis

Courtesy of Benzinga.

Vertex Pharmaceuticals (NASDAQ: VRTX) announced Sunday its 2012 business objectives in conjunction with the 30th Annual J.P. Morgan Healthcare Conference in San Francisco. Matthew Emmens, Chairman, President and Chief Executive Officer of Vertex, and Jeffrey Leiden, M.D., Ph.D., who will become Vertex’s CEO on February 1, 2012, will discuss these objectives as part of a live presentation, which will be available on Vertex’s website, www.vrtx.com, on Monday, January 9 at 11:00 a.m. PT (2:00 p.m. ET).

“In 2011, our team executed a highly successful launch for INCIVEK in hepatitis C, with more than 25,000 people starting treatment since its approval in mid-2011,” said Mr. Emmens. “With the strength of the launch for INCIVEK, the submission of our global approval applications for KALYDECO in cystic fibrosis and the advancement of our pipeline programs, we are positioned for significant growth, earnings and cashflow in 2012.”

In December, Vertex announced that the U.S. Food and Drug Administration accepted the New Drug Application for KALYDECO and granted the company’s request for six-month Priority Review. A target review date of April 18, 2012 is set under the Prescription Drug User Fee Act for the FDA’s approval decision. Vertex’s marketing authorization application for KALYDECO has also been validated by the European Medicines Agency, which accepted Vertex’s request for accelerated assessment in Europe.


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