SOURCE: BioMedReports


February 11, 2011 13:12 ET

Report: Dual Pending Catalysts May Boost Antares Pharma

LOS ANGELES, CA--(Marketwire - February 11, 2011) - Shares of Antares Pharma will be in focus early next week as biotech investors await data from a clinical data presentation this weekend. In addition, the company is waiting for a key decision from Food and Drug Administration officials regarding a recently filed New Drug Application. That news from U.S. regulators could come as early as next week.

Antares officials announced in December that they had filed a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for Anturol Gel in patients with an overactive bladder (OAB). The company expects to hear from the FDA as to whether the application is accepted. Data submitted as part of that application was supported by a Phase 3 trial conducted under a Special Protocol Assessment (SPA) with the FDA. Industry observers feel the company has a good chance at earning approval given the Phase III data and SPA.

Biotech investors and the rest of the medical community will also get an update on the largest-ever safety study comparing low-dose testosterone treatments to placebo treatment for menopausal women who suffer from Hypoactive Sexual Desire Disorder (HSDD).

Antares Pharma is one of two companies in prime position to benefit from good news associated with the updated clinical information which will be disclosed at a weekend symposium.

Antares holds a large stake in LibiGel -- a testosterone gel that is the focus of that Phase III clinical trial and is now clearly the lead product in development for treating female sexual dysfunction. BioSante Pharmaceuticals, the partner who is currently pushing the drug candidate through the development and approval process, will present the data this weekend at the Annual Meeting of The International Society for the Study of Women's Sexual Health Meeting (ISSWSH) in Scottsdale, Arizona.

Antares owns the international licensing rights to LibiGel in significant territories throughout the rest of the world, including Europe. In addition, the company controls the manufacturing for the drug. That presents a multi-billion dollar market opportunity for the company's Advanced Transdermal Delivery (ATD) Gel System- an ideal means to deliver testosterone in a controlled and reproducible way with a convenient to use dosage form.

Antares'platform allows LibiGel to be absorbed quickly through the skin after applying a once-daily, pea-sized topical application on the upper arm. The dose delivers testosterone to the bloodstream evenly over time.

Stock prices for both firms have been rising in recent days.

A full special report about the market opportunity facing both companies is now available at:

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