FDA's New "Breakthrough" Designation Allows New Drugs to Gain Approval After Just 1 Round of Testing

Five Star Equities Provides Stock Research on Medivation and Vertex Pharmaceuticals

Marketwired

NEW YORK, NY--(Marketwire - Mar 7, 2013) - Programs developed by the U.S. Food and Drug Administration to speed up the approval process have been a major driver for growth within the Biotech Industry. In 2012, FDA drug approvals totaled a 15-year high of 39, over the past decade drug approvals has averaged roughly 23 a year, according to a recent Bloomberg article. Five Star Equities examines the outlook for companies in the Biotechnology Industry and provides equity research on Medivation Inc. (NASDAQ: MDVN) and Vertex Pharmaceuticals Inc. (NASDAQ: VRTX).

Access to the full company reports can be found at:

www.FiveStarEquities.com/MDVN

www.FiveStarEquities.com/VRTX

The FDA's new "breakthrough" product designation allows new drugs to win approval after just a single round of testing, instead of the usual three. A total of three promising experimental medicines have been assigned the new status so far, while an additional 18 drugs have applied. The new designation follows three other programs -- Fast Track, Priority Review and Accelerated Approval -- each of which were designed to help bring crucial new drugs to market in a shorter amount of time.

"A breakthrough drug is one that may offer important new benefits for patients with serious or life-threatening disease who are especially in need of new safe and effective treatments," said Janet Woodcock, director of FDA's Center for Drug Evaluation and Research.

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Medivation is a biopharmaceutical company focused on the rapid development of novel therapies to treat serious diseases for which there are limited treatment options. Shares of the company have gained over 35 percent in past year. On August 31, 2012 the FDA approved Medivation's prostate cancer drug, XTANDI. Net sales for XTANDI in the fourth quarter of 2012 totaled $57.4 million.

Vertex scientists and their collaborators are working on new medicines to cure or significantly advance the treatment of hepatitis C, cystic fibrosis, rheumatoid arthritis and other life-threatening diseases. The FDA earlier this year granted the first two Breakthrough Therapy Designations to ivacaftor monotherapy and the combination regimen of VX-809 with ivacaftor for Cystic Fibrosis.

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