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Is This Biotech's Shortened Study Good Enough for Approval?

Brian Orelli, Ph.D.
September 5, 2012

BioSante Pharmaceuticals (Nasdaq: BPAX  ) is stopping its long-term safety trial for its female sexual dysfunction, LibiGel, because the biotech thinks it has enough safety data to gain approval -- and for "other considerations."

My guess is those "other considerations" have a lot to do with the amount of cash in BioSante's bank account. The biotech had $42.4 million in the bank at the end of the second quarter and raised $3.3 million more in a secondary offering last month. It spent $7.1 million in the second quarter, giving it a runway of about six quarters if it doesn't change its burn rate.

But it will. Despite being unable to demonstrate in two phase 3 trials that LibiGel is able to increase women's sexual appetite, BioSante plans to press on with two new phase 3 trials. Those aren't going to be cheap. The company burned through about $14 million in the second quarter of last year when it had trials up and running.

BioSante has one approved drug, Bio-T-Gel, to treat men with low testosterone. BioSante licensed the drug to Teva Pharmaceuticals (NYSE: TEVA  ) , which hasn't launched it yet -- perhaps because a patent-infringement lawsuit with Abbott