More than a decade after the introduction of Viagra, which spawned an everbroadening market for treating male sexual dysfunction, there’s still no equivalent product for women. That’s something BioSante CEO Stephen Simes aims to change with LibiGel, a transdermal testosterone gel treatment for female sexual dysfunction. “There is a real unmet medical need here,” he says, noting that the sexual dysfunction market is at least as large—if not larger—for women as it is for men.
In fact, 43 percent of women surveyed in a University of Chicago study reported experiencing sexual dysfunction, as compared with 31 percent of men. What’s more, each year an estimated four million off-label prescriptions (or pharmaceutical drugs prescribed for conditions other than those for which they were approved by the FDA) are written by gynecologists for hypoactive sexual desire disorder—the main component of female sexual dysfunction, says Simes. Those figures suggest a healthy potential demand for BioSante’s entry, LibiGel, which has been shown to increase women’s sexual desire and activity and decrease sexual distress. “At four million prescriptions, we’re looking at a $1 billion to $1.5 billion annual market—a potential blockbuster.”
How did little BioSante—which reported revenues of just under $2.5 million for 2010 and has sunk an estimated $100 million into the development of LibiGel—swing a first-to-market position in the behemoth-dominated pharma industry? Put succinctly, it simply outlasted its competitors. Simes says that Procter & Gamble had a similar product in development, but dropped out of the FDA approval process. And another potential contender, German company Boehringer Ingelheim, reportedly faltered due to poor results in Phase III clinical trials.
Meanwhile Lincolnshire, Ill.-based BioSante—which currently markets a treatment for hot flashes known as Elestrin—achieved strong results in Phase II clinical trials and is now in the midst of two Phase III safety and efficacy clinical trials. “The first women enrolled recently reached the third year on therapy,” reports Simes, who says results have been promising. “Our agreement with the FDA is that we can submit the new drug application and get approval based on an average of 12 months of exposure, which we now have. So we hope to submit by the end of this year for approval in 2012.”
But even assuming FDA approval—a big assumption, as the FDA is infamous for last minute upsets—BioSante faces additional hurdles in realizing LibiGel’s potential. The biggest will be finding a partner with the marketing and distribution wherewithal to bring the product to market, or selling the company outright.
Simes is sanguine about both options. “For a partnership, we would need to get something in place in the next 12 to 18 months because by then we could very well have FDA approval,” he says.
“But both avenues are attractive to us. My job as CEO is to not only run the company and make progress, but to maximize stockholder value in whatever form that comes.”