Shares of BioSante Pharmaceuticals shot up 69 percent in pre-market trading after the developer announced positive late-stage safety data for its female dysfunction treatment LibiGel. The developer says that the trial demonstrated that LibiGel is safe, with only five cardiovascular events reported with no deaths in the group.
"We are happy to see that LibiGel continues to show its safety in healthy women, and also in those women with at least two cardiac risk factors enrolled in our cardiovascular and breast cancer safety study," said BioSante CEO Stephen M. Simes. "We will continue to analyze blinded cardiac event data on a regular basis. LibiGel remains the only pharmaceutical product in the U.S. in active development for the treatment of hypoactive sexual desire disorder in menopausal women. We continue to believe that LibiGel can be the first product approved by the FDA for this common and unmet medical need also referred to as female sexual dysfunction."
BioSante said earlier this week that would use the $20 million to $25 million it expects to gain from a merger with Cell Genesys to fund development and regulatory filings for LibiGel. BioSante is conducting two LibiGel Phase III efficacy trials and expects to file for approval by mid-2011.
- check out the press release
- read the story from Reuters