U.S. Food and Drug Administration Approved 30% More Drugs in 2012

NEW YORK, NY -- (Marketwire) -- 02/22/13 -- 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 InterMune, Inc. (NASDAQ: ITMN) and Repros Therapeutics Inc. (NASDAQ: RPRX).

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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 lead 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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InterMune's Pirfenidone, the only medicine approved for idiopathic pulmonary fibrosis anywhere in the world, is marketed by InterMune in the EU and Canada as Esbriet and is currently in a Phase 3 clinical trial to support regulatory registration in the United States. The company reported Esbriet net revenue grew to $8.2 million in the fourth quarter, compared to $2.7 million a year ago.

Repros Therapeutics, a development stage biopharmaceutical company, focuses on the development of new drugs to treat hormonal and reproductive system disorders. Shares of the company were sent soaring Thursday after announcing it has received approval to proceed with its late-stage study of their testosterone drug, Androxal.

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