New Programs Designed to Speed up Approval Process a Key Factor in Biotech Industry's Growth in 2012

NEW YORK, NY -- (Marketwire) -- 03/19/13 -- 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 ImmunoCellular Therapeutics Ltd. (NYSE: IMUC) and Nektar Therapeutics (NASDAQ: NKTR).

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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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ImmunoCellular Therapeutics is developing immune-based therapies for the treatment of brain and other cancers. The company is conducting a Phase II trial of its lead product candidate, ICT-107, a dendritic cell-based vaccine targeting multiple tumor-associated antigens for glioblastoma. The company expects to release results of the interim analysis of the ongoing ICT-107 phase II clinical trial in the second quarter.

Nektar has a robust R&D pipeline of potentially high-value therapeutics in pain, oncology and other therapeutic areas. In the area of pain, Nektar has an exclusive worldwide license agreement with AstraZeneca for naloxegol (NKTR-118), an investigational drug candidate, which has completed Phase 3 clinical development as a once- daily, oral tablet for the treatment of opioid-induced constipation.

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