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BioSante Pharma - More Than Just Feminine

biosante 070511

Sexual dysfunction in females is no longer a taboo subject and there has been a growing awareness of the disorder among women. Female sexual dysfunction, or FSD for short, is defined as a lack of sexual desire, arousal or pleasure. Studies estimate that more than 40 percent of American women or about 40 million have some form of sexual dysfunction.

Hormones like estrogen and testosterone play an important role in regulating sexual function in women. Through aging, menopause, disease or trauma, the hormonal levels decline affecting the sexual function.

Working on a cure for FSD is Lincolnshire, Illinois-based specialty pharmaceutical company BioSante Pharmaceuticals Inc. (BPAX). The product under development for female sexual dysfunction, specifically, hypoactive sexual desire disorder in menopausal women, is LibiGel, a once daily transdermal testosterone gel in phase III clinical testing under a Special Protocol Assessment. Hypoactive sexual desire disorder is the most common type of female sexual dysfunction.

LibiGel is a gel formulation of testosterone, designed to be quickly absorbed through the skin after a once-daily application on the upper arm, delivering testosterone to the bloodstream evenly over time and in a non-invasive and painless manner. Although testosterone is usually thought of as a male sexual hormone, its deficiency has been found to decrease sex drive in women.

Currently, two phase III efficacy trials and one cardiovascular and breast cancer safety study are underway for LibiGel. The company has completed enrollment in the two efficacy trials as well as the safety study.

The on-going phase III efficacy trials are double-blind, placebo-controlled trials, which have enrolled more than 1,000 menopausal women while the phase III cardiovascular and breast cancer safety study has enrolled over 3,550 women. Results from the two pivotal phase III efficacy trials for LibiGel are expected in the fourth quarter of 2011.

Assuming the trial results are positive, the NDA for LibiGel is anticipated to be submitted next year. Since there is no FDA-approved treatment for hypoactive sexual desire disorder, the company expects the LibiGel NDA to be given a priority review status.

Female sexual dysfunction is a significant unmet medical need. Last October, German pharmaceutical company Boehringer Ingelheim discontinued the development of its FSD drug candidate Flibanserin pill, which was under phase III testing, following the FDA questioning the safety and efficacy of the compound. In 2004, a testosterone patch called Intrinsa developed by Procter & Gamble for treating hypoactive sexual desire disorder in postmenopausal women was rejected by the FDA on the ground of efficacy and safety risks. However, Intrinsa testosterone patch is approved in Europe and has been marketed there since 2007.

Nationally, it is estimated that 4.1 million off-label testosterone prescriptions are filled annually for treatment of FSD. The market potential for FSD is estimated to be more than $2.0 billion.

If things pan out the way as expected, LibiGel will be the first product approved by the FDA for hypoactive sexual desire disorder in menopausal women. LibiGel is patented until mid-2022.

Now about the other planned milestones of the company...

Bio-T-Gel, a once daily transdermal testosterone gel for the treatment of hypogonadism, or testosterone deficiency in men, is under review by the FDA. The product, which is licensed to Teva Pharmaceutical Industries Ltd. (TEVA), has a FDA decision date on November 14, 2011. Testosterone gel sales totaled $1.1 billion in 2010.

Pill Plus, a once daily triple hormone oral contraceptive, containing estrogens, progestogens and androgens, is under phase II development for the treatment of FSD in women using oral or transdermal contraceptives. Last June, BioSante reported positive clinical results from a phase II Pill-Plus study. Additional clinical results in the Pill-Plus' development program are expected this year.

The Pill-Plus United States patents for oral use are licensed by BioSante to Pantarhei Bioscience, a Netherlands-based pharmaceutical company, for development and marketing in the United States. BioSante retains rights to the Pill-Plus for transdermal development and marketing.

BioSante not only develops female sexual health products but has also jumped on the cancer bandwagon. The company has a portfolio of cancer vaccines known as GVAX vaccines in phase II clinical development for the treatment of various cancers, including pancreatic cancer, leukemia, prostate cancer and breast cancer.

The GVAX vaccine candidates came under BioSante's fold following its purchase of Cell Genesys in 2009.

In August 2008, Cell Genesys halted a phase III study of GVAX prostate cancer vaccine as mortality rate was higher in patients who were given the vaccine compared to the control arm. In September of that year, the FDA placed a partial clinical hold on the GVAX Phase III program for prostate cancer. The following month - in October 2008, a second GVAX trial in prostate cancer was halted following an independent Data Monitoring Committee analysis, which indicated that the trial had a less than 30 percent chance of meeting its predefined primary endpoint of an improvement in survival.

Last month, the FDA lifted its clinical hold on the GVAX prostate cancer vaccine. Manufacturing of new GVAX Prostate is complete, and planning for a phase II clinical trial at the Johns Hopkins Kimmel Cancer Center is underway.

BioSante licensed its pancreas cancer vaccine and prostate cancer vaccine to Aduro BioTech, a clinical-stage immunotherapy company in April of this year. Aduro plans to initiate a phase II trial of the pancreas vaccine in the fourth quarter of 2011 with approximately 90 late-stage pancreatic cancer patients.

BioSante has one FDA-approved product, Elestrin, a once daily transdermal estrogen gel indicated for the treatment of hot flashes associated with menopause and marketed in the U.S. Elestrin was approved by the FDA in December 2006 and is patented through June 2022. Dublin, Ireland-based Azur Pharma has the US rights to Elestrin.

The technology underlying certain gel products of BioSante, including LibiGel and Elestrin, is licensed from Antares Pharma Inc. (AIS). BioSante is obligated to pay Antares certain development and regulatory milestone payments and royalties.

A quick look at the company's balance sheet...

Since its inception in 1996, BioSante has incurred significant operating losses resulting in an accumulated deficit of $182.88 million. As of March 31, 2011, the company had about $51.3 million in cash. The monthly burn rate is estimated to be about $4.0 million for 2011 and is expected to be about $3 million for 2012.

Shares of BioSante have a 52-week range of $1.29 to $3.20. The company has 93.6 million shares outstanding. *Insiders hold over 6% and institutions hold over 29% of the outstanding stock. (*Data sourced from Yahoo Finance).

Updated News

The FDA decision on Bio-T-Gel has been extended by three months to February 14, 2012.

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