Female Sexual Dysfunction Drug Study Data Looks Positive. Update Expected from BIO CEO & Investor Conference Print E-mail
By Staff and Wire Reports   
Monday, 14 February 2011 07:26

Since other drugs designed to boost the sex drive in women have failed to reach market, we expect investors will take note of two companies we told our subscribers and readers about last week. On Saturday, positive test results were reported for a drug that it hopes will become the first treatment to boost the sex drive of menopausal women. In addtion, A detailed LibiGel safety study update will be presented today at the BIO CEO & Investor Conference.

Data from weekend's LibiGel presentation could boost Biosante and Antares Pharma

BioSante Pharmaceuticals Reports Positive LibiGel® Safety Data in Phase III Program

Two companies in prime position to benefit from good news associated with this weekend’s updated clinical information are BioSante Pharmaceuticals (Nasdaq:BPAX) and their partner, Antares Pharma, Inc. (AMEX: AIS ). Both companies have 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.  The efficacy trials are being conducted under an FDA-approved special protocol assessment (SPA) agreement.

While BioSante has been pushing the product through development, many investors may not be aware that a patented FDA approved technology developed by Antares is a critical component in Libigel. The company’s Advanced Transdermal Delivery (ATD) Gel System offerd BioSante an ideal means to deliver testosterone in a controlled and reproducible way with a convenient to use dosage form.

Over the weekend, the the company reported 17 cardiovascular incidents and eight breast cancer occurrences in the study of 2,869 women. The rates are sufficiently low to allow the company to proceed with testing in accordance with Food and Drug Administration rules. The results were from late-stage safety tests of the drug, LibiGel, a gel which is applied to the skin to deliver testosterone to the bloodstream.

The company will likely use this safety data as part of its new drug application to the FDA after 12 months a they hope to have LibiGel ready for launch in 2012.

Last June, the FDA's panel of reproductive advisers rejected the antidepressant drug flibanerin, saying the benefits of the pill did not outweigh the fatigue, depression and fainting spells it caused in some women.

Since the launch of Pfizer's erectile dysfunction drug Viagra in 1998, more than two dozen experimental therapies have been studied for so-called "female sexual dysfunction," a market worth an estimated $2 billion.

In 2004, an FDA panel rejected Procter & Gamble's testosterone patch, Intrinsa, because of unknown risks from long-term use. Two years earlier, a massive government study found that hormone replacement therapy in postmenopausal women increased heart disease and breast cancer. The study raised concerns about the safety of all hormones.

Stephen M. Simes, BioSante’s president & CEO, will speak today, Monday February 14, 2011 at 3:30 pm EST. He will provide an overview of the company, as well as an update on LibiGel® (testosterone gel) Phase III clinical development program including safety data. A live audio webcast of Mr. Simes’ remarks may be accessed at: http://www.veracast.com/webcasts/bio/ceoinvestor2011/16113289.cfm

M.E. Garza of BioMedReports is covering the conference at the Waldorf-Astoria in New York and will be providing news and updates.




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