This weekend, biotech investors and the rest of the medical community will 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).

To date, the ongoing late stage clinical study has enrolled more than 2,800 women who suffer from the disorder which has come to be known as a persistently reduced sexual drive or libido, not attributable to depression where there is reduced desire, sexual activity and reduced sexual fantasy.

Approved Hormonal Treatments for HSDD: An Unmet Medical Need Update on LibiGel® Safety Study at ISSWSH Meeting Flash Player 9 or higher is required to view the chart Click here to download Flash Player now Flash Player 9 or higher is required to view the chart Click here to download Flash Player now

"HSDD is the most common sexual problem in women Baby Boomers, particularly those who are naturally and surgically menopausal," noted sexual health expert Dr. Sheryl A. Kingsberg said in a recent interview. "Most women have been lead to think the problem is simply mind over matter and do not realize that this is a real health issue, a misperception that is not allowing them to reap the benefits of a healthy sex life."

Because testosterone is the hormone responsible for creating sexual desire in both men and women, doctors looking for treatment options often start by looking at a patient’s testosterone levels first. Drug developers looking for answers to the problem started there too.

Data from these clinical trials is highly anticipated by the investment community because the search for a safe and effective version of “Viagra for women” has kept both patients and the medical world waiting for some time. Despite a high prevalence of sexual desire disorder, no regulator approved medical treatment has been made available in the United States.
The need for an FDA approved product to treat female sexual dysfunction becomes even clearer when one looks at the number of testosterone prescriptions written off-label in the U.S. for women. Recent estimates put that number at over two million and even higher when "compounded" testosterone prescriptions are included.
A multi-billion dollar market opportunity for any company that can push a proven treatment across the finish line is substantial.  In fact, ninety percent of physicians surveyed say they would prescribe an FDA approved product over currently prescribed hormone therapies, especially since many of the dosage levels must be monitored so closely and often vary significantly from patient to patient. Health risks associated with fluctuating testosterone treatments have also sparked a controversy among researchers over the role of testosterone in heart disease and breast cancer.

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.

“We have an advanced and deep pipeline of ATD based products, including LibiGel, where we have significant intellectual property and commercialization rights,” said Paul Wotton, President and CEO of Antares in an interview with Pharmaceutical Business Review . “We expect to earn additional milestone and royalty payments in the future from our multi-product agreement with BioSante.”

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. 

BioSante, who recently reported favorable unblinded safety data associated with the treatment and plans to file a New Drug Application with U.S. regulators in 2011, estimates that the unmet need for the treatment could position Libigel to capture a large portion of an addressable $2 billion market. Those are clearly the types of numbers that draw partnerships from big pharma and officials at the company say that they are actively seeking partners with the appropriate infrastructure to manage the commercialization of their development efforts.

Whoever comes to the table will also have to deal with Antares, who 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.

Stock prices for both firms have been rising in anticipation of this weekend’s data presentation as speculators hope that safety and efficacy studies continue to point in the direction of an FDA approval for LibiGel.

The safety study update is scheduled to take place this weekend at the Annual Meeting of The International Society for the Study of Women's Sexual Health Meeting (ISSWSH) in Scottsdale, Arizona.

More than 300 experts and practitioners in women's health and female sexual dysfunction (FSD) are expected at the meeting where Michael Snabes, MD, PhD, BioSante's senior vice president of medical affairs, will deliver an oral presentation entitled, "LibiGel® (testosterone gel) Safety Study Continues with a Low Rate of Cardiovascular and Breast Cancer Events," on Saturday at 3 pm local time.

In addition to that catalyst, Antares Pharma 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 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.



Disclosure: No position in BPAX, Long AIS

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