NEW YORK, NY -- (Marketwire) -- 03/20/13 -- 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 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 Exelixis, Inc. (NASDAQ: EXEL) and Lexicon Pharmaceuticals, Inc. (NASDAQ: LXRX).
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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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Exelixis is a biotechnology company committed to developing small molecule therapies for the treatment of cancer. Exelixis received approval by the FDA to market COMETRIQ in the United States for the treatment of progressive, metastatic MTC in November 2012. The company has selected Swedish Orphan Biovitrum as European distributor of COMETRIQ.
Lexicon Pharmaceuticals' genomics-based approach to drug discovery has enabled our scientists to select drug targets across a broad range of indications with high unmet medical need. The company has advanced new therapies across a wide spectrum of human disease, from conditions affecting millions of people, such as diabetes, to carcinoid syndrome, an orphan cancer indication with few treatment options.
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