SOURCE: The Bedford Report

The Bedford Report

February 17, 2011 11:25 ET

Regulatory Process Is an Ongoing Challenge for Xoma & BioSante

The Bedford Report Provides Analyst Research on XOMA & BioSante

NEW YORK, NY--(Marketwire - February 17, 2011) -  There is plenty of optimism surrounding the Biotech industry as firmer pricing and new products have improved sales and earnings trends. Meanwhile, more speculative biotech firms such as XOMA and BioSante continue to garner significant attention with potential blockbuster drugs working their way through the regulatory process.The Bedford Report examines the outlook for companies in the Biotechnology Industry and provides research reports on XOMA, Ltd. (NASDAQ: XOMA) and BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX). Access to the full company reports can be found at:

A recent study released by BIO and BioMedTracker claims that the success rate in bringing new medicines to market in the past six years is only about half of what it had been previously. The study claims, however that biotech drugs are twice as likely to gain approval than more traditional chemical drugs.

The study found that drugs moving from early stage Phase I clinical trials to FDA approval is roughly ten percent, down from around 20 percent in reports involving earlier years.The report adds that approval applications were filed for 55 percent of the drugs that made it to Phase III testing, and 80 percent of those gained eventual approval -- though only half were approved on initial review.

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Earlier this month BioSante reported positive late stage safety data for its potential blockbuster drug, "LibiGel". LibiGel is designed as a possible treatment for sexual dysfunction in menopausal women. BioSante's senior vice president of medical affairs, Michael C. Snabes, argues that "The need for an FDA-approved treatment to cope with this condition is astonishing."

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