Dec 14 (Reuters) - BioSante Pharmaceutical Inc said its experimental gel to improve libido in postmenopausal women failed to meet the main goal in late-stage efficacy trials, marking the failure of another female aphrodisiac from reaching the market.
The news wiped out more than three-quarters of the company's market value in trading after the bell on Wednesday.
BioSante said LibiGel-treated patients achieved slightly more days with a satisfying sexual event in the trial, but that finding might as well have been due to chance. Although the drug improved testosterone levels of the subjects, it failed to improve their sexual desire, failing to meet its main goal.
The company said it is in reviewing the trial data to chart out the future course of action for the drug.
"We will be looking to see if there are certain subsets of the data ... whether there is an age of patients who are responding or more likely to respond and so on," the company said on a call with analysts.
The treatment, LibiGel -- the only female sexual disorder treatment to reach late-stage trials -- was considered a promising contender for approval, after several other such hopefuls failed.
In 2004, a U.S. Food and Drug Administration panel had rejected Procter & Gamble's experimental testosterone patch Intrinsa citing safety concerns. Alista, another attempt by Vivus Inc, failed a mid-stage trial in 2006.
LibiGel, a once-daily testosterone gel is topically applied on the upper arm, which allows it to be absorbed through the skin and deliver testosterone to the bloodstream over time.
"The LibiGel Phase III cardiovascular and breast cancer safety study currently continues as planned, we will be analyzing the best path forward," BioSante's Chief Executive Officer Stephen Simes said. The company had earlier said it expected results from the safety trial in the third quarter of next year.
Roth Capital Partners analyst Scott Henry said the company had a low likelihood of reaching this stage with the drug again, unless it finds a subset to indicate a different outcome.
"The company is fortunate to have a solid balance sheet to reinvent itself beyond LibiGel," Henry said, noting that the company had spent much less on this trial as compared with the money spent on the safety trial.
As of Sept. 30, the company had a cash balance of $69.6 million, a figure it expects to come down to $56 million by year-end.
SOURCE: http://bit.ly/tpEro7 BioSante Pharmaceuticals, December 14, 2011.
