NEW YORK, NY--(Marketwire - Feb 8, 2013) - 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 Optimer Pharmaceuticals, Inc. (NASDAQ: OPTR) and Santarus, Inc. (NASDAQ: SNTS).
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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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Optimer Pharmaceuticals is a global biopharmaceutical company focused on developing and commercializing innovative hospital specialty products that have a positive impact on society and provide value for the healthcare system. The company reported preliminary fourth quarter 2012 sales of DIFICID, a FDA approved treatment for Clostridium difficile-associated diarrhea, were $21.3 million in the U.S. and Canada.
Santarus' current commercial efforts are focused on GLUMETZA and CYCLOSET tablets, which are indicated as adjuncts to diet and exercise to improve glycemic control in adults with type 2 diabetes, and on FENOGLIDE tablets, which is indicated as an adjunct to diet to reduce high cholesterol. In mid-February 2013, the company plans to begin promoting UCERIS for the treatment of mild to moderate ulcerative colitis.
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