SOURCE: The Bedford Report

The Bedford Report

December 01, 2011 08:16 ET

Drug Candidates From Alexza and BioSante Pharmaceuticals Inch Closer to Decision Day

The Bedford Report Provides Equity Research on Alexza Pharmaceuticals & BioSante Pharmaceuticals

NEW YORK, NY--(Marketwire - Dec 1, 2011) - 2012 is shaping up to be a big year for the biotechnology industry with several drug candidates facing FDA advisory panels. The drug approval rate in the United States has been falling in recent years -- studies released this year courtesy of the Biotechnology Industry Organization peg the country's overall success rate at close to ten percent -- which have led to volatile swings in shares throughout the biotechnology sector. The Bedford Report examines the outlook for companies in the biotechnology industry and provides investment research on Alexza Pharmaceuticals, Inc. (NASDAQ: ALXA) and BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX). Access to the full company reports can be found at:

In its third quarter report, BioSante Pharmaceuticals said that its Bio-T-Gel, a testosterone gel for male hypogonadism licensed to Teva Pharmaceuticals, has been assigned an FDA approval decision date of February 14, 2012. Male hypogonadism generally characterized by impotence, a lack of sex drive, muscle weakness and osteoporosis. BioSante says that the transdermal testosterone market for men in the US was over $1.2 billion in 2010.

BioSante is also developing LibiGel to treat female sexual dysfunction, specifically hypoactive sexual desire disorder, in postmenopausal women, for which there is no Food and Drug Administration-approved product. Shares of the company got a boost last month after it said a study shows its LibiGel increased free-testosterone levels in postmenopausal women.

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Alexza Pharmaceuticals is a development stage company focused on the research, development, and commercialization of novel proprietary products for the acute treatment of central nervous system conditions. Alexza is meeting with an FDA advisory panel this month to review the company's inhalation product candidate Adasuve for the rapid treatment of agitation in patients with Schizophrenia or Bipolar Disorder. The FDA had initially rejected Adasuve in October 2010 due to concerns over lung safety. Alexza resubmitted the drug to FDA last August. According to Alexza's website, the NDA PDUFA goal date is Feb. 4, 2012.

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