Higher Rate of FDA New Drug Approvals a Major Factor in Biotech Industry's Success in 2012
Five Star Equities Provides Stock Research on Athersys and Santarus
NEW YORK, NY -- (Marketwire) -- 12/10/12 -- 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 25 percent year-to-date. Five Star Equities examines the outlook for companies in the Biotech Industry and provides equity research on Athersys, Inc. (NASDAQ: ATHX) and Santarus, Inc. (NASDAQ: SNTS).
"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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Athersys is developing its MultiStem cell therapy product, a patented, adult-derived "off-the-shelf" stem cell product platform for disease indications in the cardiovascular, neurological, inflammatory and immune disease areas. The company has been granted orphan drug designation by the FDA for MultiStem cell therapy to treat Hurler's Syndrome.
Santarus is a specialty biopharmaceutical company focused on acquiring, developing and commercializing proprietary products that address the needs of patients treated by physician specialists. The company's 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.
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