Is This Biotech's Shortened Study Good Enough for Approval?http://www.fool.com/investing/high-growth/2012/09/05/is-this-biotechs-shortened-study-good-enough-for-a.aspx 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