U.S. Food and Drug Administration Approved 30% More Drugs in 2012 Than the Year Previous

NEW YORK, NY -- (Marketwire) -- 03/19/13 -- A sharp increase in drug approvals and mergers and acquisitions combined to create a bull market for the Biotechnology Industry in 2012. The iShares NASDAQ Biotechnology Index (IBB), the SPDR S&P Biotech ETF (XBI) and the First Trust Amex Biotechnology Index ETF (FBT) have all gained over 20 percent in the past year, outperforming the broader markets by a good margin. Research Driven Investing examines investing opportunities in the Biotech Industry and provides equity research on Protalix BioTherapeutics Inc. (NYSE: PLX) and Supernus Pharmaceuticals Inc. (NASDAQ: SUPN)

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Bloomberg recently reported drug approvals by the U.S. Food and Drug Administration reached a 15 year high in 2012. The FDA approved a total of 39 novel medicines last year, an increase of 30 percent when compared to a year ago. Oncology drugs led the way with 11 new drugs approved last year. Over the last ten years the number of FDA approvals had averaged roughly 23 a year. The passage of the Prescription Drug User Fee Act (PDUFA) played a major role in the sharp increase in approvals.

The PDUFA "has provided critical resources for improving the quality and timeliness of premarket review of drugs," said FDA spokeswoman, Sandy Walsh. "These accomplishments could not have been achieved without the innovations of the biopharmaceutical industry and the dedication and skill of FDA's drug review staff."

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Protalix is developing investigational therapies to address multiple areas of unmet medical need including, Fabry disease, biodefense indications, and autoimmune diseases (including rheumatoid arthritis). The company has recently received approval from the Israeli Ministry of Health to initiate a phase I clinical trial of PRX-112.

Supernus Pharmaceuticals is developing several product candidates in neurology and psychiatry to address unmet medical needs and opportunities in epilepsy, attention-deficit hyperactivity disorder (ADHD) and its coexisting disorders, and depression. Shares of the company fell sharply Monday after reporting their net loss grew in the fourth quarter of 2012.

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