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

NEW YORK, NY -- (Marketwire) -- 02/18/13 -- 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 Affymax, Inc. (NASDAQ: AFFY) and Incyte Corp. (NASDAQ: INCY).

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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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Affymax's first marketed product, OMONTYS (peginesatide) Injection, was approved by the FDA in March 2012. In the U.S., Affymax is currently conducting a Phase 3b study to evaluate the process and outcomes of converting dialysis centers from a three times per week ESA to once-monthly OMONTYS Injection. Shares of the company have gained nearly 60 percent year-to-date.

Incyte's lead product, Jakafi (ruxolitinib), a JAK1 and JAK2 inhibitor, is currently approved in the United States for the treatment of intermediate or high-risk myelofibrosis and is in development as a potential treatment for other cancers. The company reported revenues for the fourth quarter soared to $113.8 million, compared to $28.9 million a year ago.

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