New Programs Designed to Speed Up Approval Process a Key Factor in Biotech Industry's Growth in 2012
Five Star Equities Provides Stock Research on NuPathe and StemCells
NEW YORK, NY -- (Marketwire) -- 03/21/13 -- 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 NuPathe Inc. (NASDAQ: PATH) and StemCells Inc. (NASDAQ: STEM).
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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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NuPathe's first commercial product is Zecuity for the acute treatment of migraine. The company is seeking commercialization partners in the U.S. and worldwide. In addition, NuPathe has a strong pipeline based on our biodegradable implant technology that allows us to deliver therapeutic levels of medication over a period of months with a single dose.
StemCells is engaged in the research, development, and commercialization of cell-based therapeutics and tools for use in stem cell-based research and drug discovery. The Company's lead therapeutic product candidate, HuCNS-SC cells (purified human neural stem cells), is currently in development as a potential treatment for a broad range of central nervous system disorders.
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