Contributing Writer

With a mid-December PDUFA date looming, BioSante Pharmaceuticals Inc. signed over exclusive U.S. marketing rights for Bio-E-Gel (transdermal estradiol gel), the lead product in its pipeline, to Bradley Pharmaceuticals Inc.

Lincolnshire, Ill.-based BioSante will receive 75 percent of the payments associated with the $54 million deal. The remaining 25 percent will go to Antares Pharma Inc., which created the transdermal gel formulations used in several of BioSante's products, including Bio-E-Gel. Antares also holds commercialization rights to Bio-E-Gel in Europe and certain other territories.

Up-front payments include $2.6 million to BioSante and $0.9 million to Antares, followed closely by regulatory milestone payments of up to $7.9 million for BioSante and $2.6 million for Antares. If all goes as planned and Bio-E-Gel is launched by Bradley in 2007, BioSante and Antares can look forward to sales-based milestone payments of $30 million and $10 million, respectively, as well as undisclosed royalties.

BioSante President and CEO Stephen Simes said the company talked to several potential suitors about Bio-E-Gel, but ultimately chose Bradley because it is an "aggressive marketer" and the product would have "significant value" for them.

Bio-E-Gel is a topical gel formulation of estradiol, a naturally occurring estrogen hormone, designed to deliver a steady dose of medication over 24 hours. The FDA is currently reviewing low-dose, mid-dose and high-dose formulations for the treatment of moderate to severe hot flashes in menopausal women. The companies estimated that there are about 14,000 OB/GYN physicians in the U.S. who prescribe most estrogen therapies, and Bradley intends to target them with a 49-person niche sales force.

Just last week, Fairfield, N.J.-based Bradley received FDA approval for Polyphenon E Ointment, an external genital and perianal wart treatment it licensed from MediGene AG, of Martinsried, Germany. The drug is slated for launch next year and also will be handled by the OB/GYN-focused sales team.

Brad Glassman, senior vice president of sales and marketing at Bradley, said the company became aware of the need to license more products for its OB/GYN sales force after completing the MediGene deal, leading it to BioSante. Although transdermal estrogen products already are available, he cited certain differentiating features of Bio-E-Gel that make it "very exciting," but declined to make further claims ahead of the FDA decision.

The North American Menopause Society estimated that more than two-thirds of North American women have hot flashes during menopause. Estrogen therapy is the current standard of care, creating a $1.3 billion U.S. market, but studies by the Women's Health Initiative have linked estrogen to an increased risk of stroke, deep-vein thrombosis, myocardial infarction and other complications.

In a Phase III trial, Bio-E-Gel produced a statistically significant decrease in hot flashes compared to placebo (p<0.0001). More than 80 percent of women treated with Bio-E-Gel reported "great" or "moderate." According to BioSante, there were no significant differences in the safety profile of any dose of Bio-E-Gel compared to placebo other than predictable estrogen effects, such as breast tenderness.

Ilya Kravets, senior research analyst at New York-based Rodman & Renshaw LLC., said the Bio-E-Gel deal shows that BioSante is able to develop a product, bring it through the regulatory process and consummate a commercial agreement, but pointed to LibiGel, a transdermal testosterone formulation for female sexual dysfunction, as the potential "home run."

The market for female sexual dysfunction is estimated at more than $2 billion, and there currently are no approved treatments. According to Simes, Pfizer spent eight years testing Viagra in the indication, and while it was able to show increased arousal, it didn't show significantly increased sexually satisfying events. In a Phase II trial, LibiGel increased the total number of sexually satisfying events by 238 percent.

BioSante hopes to begin Phase III trials with LibiGel in late 2006 or early 2007, but FDA concerns about safety have slowed the program. In December 2004, BioSante's shares took a dive when the company first delayed the program due to FDA debate regarding the trial protocol. The day before BioSante's announcement, an FDA advisory committee voted not to recommend approval of Procter & Gamble Co.'s Intrinsa, a testosterone patch for female sexual dysfunction. The panel asked for more safety information on testosterone's effects on patients with cardiovascular risk and breast cancer. (See BioWorld Today, Dec. 6, 2004.)

Intrinsa is approved in Europe, and Simes said he believes P&G still is considering its alternatives in the U.S. In the meantime, BioSante continues to "work with the FDA" on how to prove LibiGel's safety.

Kravets thinks BioSante eventually will succeed. "An estimated 1 million women are using testosterone formulated for men, and that's not the best way to go," he said, adding that the FDA is well aware of those statistics.

BioSante is also developing Bio-T-Gel (testosterone gel) for hypogonadism in men, Bio-E+P-Gel (estradiol + testosterone gel) for menopausal symptoms and LibiGel-E/T (estradiol + testosterone gel) for the treatment of sexual dysfunction in menopausal women. The company also has preclinical vaccine adjuvant and protein delivery programs.

Shares of BioSante (AMEX:BPA) closed up 4 cents Wednesday at $1.69.

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