Biotech Industry Looks to Benefit From FDA's New "Breakthrough" Designation

Five Star Equities Provides Stock Research on Biosante Pharmaceuticals and ZIOPHARM Oncology

Marketwired

NEW YORK, NY--(Marketwire - Mar 12, 2013) - 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 Biosante Pharmaceuticals Inc. (NASDAQ: BPAX) and ZIOPHARM Oncology Inc. (NASDAQ: ZIOP).

Access to the full company reports can be found at:

www.FiveStarEquities.com/BPAX

www.FiveStarEquities.com/ZIOP

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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BioSante's products include LibiGel for the treatment of female sexual dysfunction, specifically hypoactive sexual desire disorder, which is in Phase III development. BioSante also is developing a portfolio of cancer vaccines, with 17 Phase I and Phase II clinical trials currently on-going. The company recently announced their independent proxy advisory firm, Glass, Lewis & Co., LLC, has recommended stockholders vote "FOR" the merger with ANI Pharmaceuticals, Inc.

ZIOPHARM Oncology is a biopharmaceutical company focused on the discovery and development of new cancer therapies. The company's portfolio is comprised of five clinical-stage product candidates in all phases of development, as well as multiple research-stage candidates. ZIOPHARM has recently intitiated a Phase 2 clinical study of Ad-RTS IL-12 in combination with palifosfamide for the treatment of advanced breast cancer.

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