SOURCE: Five Star Equities

Five Star Equities

March 22, 2013 08:20 ET

New Programs Designed to Speed Up Approval Process a Key Factor in Biotech Industry's Growth in 2012

Five Star Equities Provides Stock Research on Corcept Therapeutics and XenoPort

NEW YORK, NY--(Marketwire - Mar 22, 2013) - Programs developed by the U.S. Food and Drug Administration to speed up the approval process has 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 have 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 Corcept Therapeutics Inc. (NASDAQ: CORT) and XenoPort, Inc. (NASDAQ: XNPT).

Access to the full company reports can be found at:

www.FiveStarEquities.com/CORT

www.FiveStarEquities.com/XNPT

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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Corcept Therapeutics is a leader in the discovery and development of drugs that regulate the effects of cortisol. There are many diseases in which modulating cortisol activity may benefit patients. Corcept's scientific expertise surrounding the regulation of cortisol has led to the discovery of an extensive library of novel compounds that may ultimately address numerous important diseases.

XenoPort is focused on developing and commercializing a portfolio of internally discovered product candidates for the potential treatment of neurological disorders. Their first product, Horizant Extended-Release Tablets, is currently being promoted by GlaxoSmithKline in the United States. XenoPort's product candidates are being developed for the potential treatment of spasticity, Parkinson's disease and relapsing-remitting multiple sclerosis.

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