Improving Trend in FDA First Cycle Review Approvals a Major Factor for Biotech Industry's Success in 2012
Five Star Equities Provides Stock Research on Emergent Biosolutions and Synergy Pharmaceuticals
NEW YORK, NY--(Marketwire - Jan 3, 2013) - The Biotech Industry has skyrocketed in 2012 as an increase in the number of new drug approvals has boosted investor optimism within the industry. The iShares Nasdaq Biotechnology Index Fund (IBB) and the SPDR S&P Biotech ETF (XBI) have both gained over 30 percent year-to-date. Five Star Equities examines the outlook for companies in the Biotech Industry and provides equity research on Emergent Biosolutions Inc. (NYSE: EBS) and Synergy Pharmaceuticals Inc. (NASDAQ: SGYP).
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"In 2011, the U.S. FDA approved 30 new drugs, compared to 21 in 2010," S&P Capital IQ wrote in a note. "Through September 2012, the year-to-date total was 22. We see an improving trend for FDA first cycle review approvals and a rise in the rate of new drug approvals for rare diseases, which we think is helping to boost investor sentiment for the agency, after years of criticism stemming from inconsistency in making and communicating its decisions."
Another key factor in the Biotech Industry's success has been the "patent cliff" major pharmaceuticals have faced in 2012. Major drug manufacturers have looked to biotech companies to help offset major revenue losses from expiring patents as it is less time consuming than developing new drugs through R&D.
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Emergent BioSolutions is a specialty pharmaceutical company seeking to protect and enhance life by offering specialized products to healthcare providers and governments to address medical needs and emerging health threats. Shares of the company spiked sharply Wednesday after reporting their chronic lymphocytic leukemia treatment, TRU-016, received medicinal product designation from the European Commission.
Synergy Pharmaceuticals is a development-stage biopharmaceutical company that develops drugs to treat gastrointestinal disorders and diseases. Synergy's lead investigational drug, PLECANATIDE, is designed to treat Chronic Idiopathic Constipation and Constipation-Predominant Irritable Bowel Syndrome. Shares of the company soared after reporting PLECANATIDE met the primary and key secondary endpoints of a Phase IIb/III clinical study.
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