FDA Programs Designed to Speed Up Approval Process Helps Send Drug Approvals to a 15-Year High in 2012
Five Star Equities Provides Stock Research on Aegerion Pharmaceuticals and Alnylam
NEW YORK, NY -- (Marketwire) -- 03/11/13 -- Programs developed by the U.S. Food and Drug Administration to speed up the approval process has been a major driver for growth within the Biotech Industry. In 2012, FDA drug approvals totaled a 15-year high of 39, over the past decade drug approvals has averaged roughly 23 a year, according to a recent Bloomberg article. Five Star Equities examines the outlook for companies in the Biotechnology Industry and provides equity research on Aegerion Pharmaceuticals, Inc. (NASDAQ: AEGR) and Alnylam Pharmaceuticals, Inc. (NASDAQ: ALNY).
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The FDA's new "breakthrough" product designation allows new drugs to win approval after just a single round of testing, instead of the usual three. A total of three promising experimental medicines have been assigned the new status so far, while an additional 18 drugs have applied. The new designation follows three other programs -- Fast Track, Priority Review and Accelerated Approval -- each of which were designed to help bring crucial new drugs to market in a shorter amount of time.
"A breakthrough drug is one that may offer important new benefits for patients with serious or life-threatening disease who are especially in need of new safe and effective treatments," said Janet Woodcock, director of FDA's Center for Drug Evaluation and Research.
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Aegerion Pharmaceuticals plans to conduct clinical development activities to support a marketing authorization application for lomitapide in HoFH in Japan and in support their planned clinical study of lomitapide in pediatric and adolescent HoFH patients. For fiscal year 2013, the company expects net revenues to be in the range of $15 million to $20 million.
Alnylam is leading the translation of RNAi as a new class of innovative medicines with a core focus on RNAi therapeutics for the treatment of genetically defined diseases, including ALN-TTR for the treatment of transthyretin-mediated amyloidosis, ALN-AT3 for the treatment of hemophilia and rare bleeding disorders, ALN-AS1 for the treatment of acute intermittent porphyria, ALN-PCS for the treatment of hypercholesterolemia, and ALN-TMP for the treatment of hemoglobinopathies.
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