SOURCE: Research Driven Investing
NEW YORK, NY--(Marketwire - Mar 5, 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 Seattle Genetics, Inc. (NASDAQ: SGEN) and Theravance Inc. (NASDAQ: THRX).
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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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Seattle Genetics is a biotechnology company focused on the development and commercialization of monoclonal antibody-based therapies for the treatment of cancer. The company's lead program, ADCETRIS, received accelerated approval from the U.S. Food and Drug Administration in August 2011 and approval with conditions from Health Canada in February 2013 for two indications.
Theravance is a biopharmaceutical company with a pipeline of internally discovered product candidates and strategic collaborations with pharmaceutical companies. The company and GlaxoSmithKline plc recently reported that the FDA has accepted its New Drug Application for ANORO ELLIPTA for patients with chronic obstructive pulmonary disease.
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