Biotech Industry Looks to Benefit From FDA's New "Breakthrough" Designation

NEW YORK, NY -- (Marketwire) -- 03/18/13 -- 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 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 Athersys, Inc. (NASDAQ: ATHX) and Zogenix, Inc. (NASDAQ: ZGNX).

Access to the full company reports can be found at:
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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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Athersys is a clinical stage biotechnology company engaged in the discovery and development of therapeutic product candidates designed to extend and enhance the quality of human life. The Company is developing its MultiStem cell therapy product, a patented, adult-derived "off-the-shelf" stem cell product platform for disease indications in the cardiovascular, neurological, inflammatory and immune disease areas.

Zogenix is a pharmaceutical company commercializing and developing products for the treatment of central nervous system disorders and pain. In May 2012, Zogenix submitted to the FDA a New Drug Application for Zohydro ER, its lead investigational product candidate. Shares of the company spiked sharply last week after reporting their net loss shrank to $0.6 million, or $0.01 per share, for the fourth quarter of 2012.

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