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BIOSANTE BEGINS FEMALE SEXUAL DYSFUNCTION CLINICAL TRIAL.

BioSante Pharmaceuticals, Inc. (OTCBB-BTPH; CDNX-BAI), Lincolnshire, Ill., has initiated a Phase II human clinical trial of its transdermal testosterone gel, LibiGel(TM), for the treatment of female sexual dysfunction (FSD) from low testosterone levels in postmenopausal women.

"We believe that LibiGel(TM) can make an important contribution to the well-being of women and add significant shareholder value," said Stephen M. Simes, BioSante's president and chief executive officer. "Female sexual dysfunction is underserved by the pharmaceutical industry today, and we are very pleased to be initiating this important study, which marks a key milestone for our company."

Though generally characterized as a male hormone, testosterone also is present in women and its deficiency has been found to cause low libido or sex drive. Studies have shown that testosterone replacement therapy can boost sexual desire and pleasure, increase bone density, raise energy levels and improve mood.

LibiGel(TM) is a gel formulation of testosterone designed to be quickly absorbed through the skin after application on the arms, shoulders or abdomen, delivering testosterone to the blood stream evenly over time and in a non-invasive, painless manner. The Phase II trial will enroll post-hysterectomy menopausal women who have low testosterone levels, and will profile the blood levels of testosterone produced by different doses of LibiGel(TM).

BioInnovators, Inc., a pharmaceutical industry consulting group, estimates that within five years the market for testosterone products for women will exceed $600 million.

According to a 1999 University of Chicago study, 43 percent of American women (about 40 million) experience some degree of impaired sexual function. Among the 1,410 women surveyed, 32 percent lacked interest in sex and 26 percent could not experience orgasm. The majority of women with FSD are postmenopausal, experiencing FSD due to hormonal changes following menopause, whether natural or surgical.

BioSante's hormone product portfolio

In addition to LibiGel(TM), BioSante is developing Bio-T-Gel(TM) for treatment of men with testosterone deficiency and Bio-E-Gel(TM) for treatment of women with estrogen deficiency. Symptoms of these hormone deficiencies in men include impotence, diminished sex drive, muscle weakness and osteoporosis. Symptoms in menopausal women include hot flashes, vaginal atrophy, decreased libido and osteoporosis. The estrogen and testosterone markets in the United States alone account for approximately $1.5 billion in annual sales.

About BioSante Pharmaceuticals, Inc.

BioSante is an emerging pharmaceutical company developing a robust pipeline of hormone replacement products to treat hormone deficiencies in men and women. BioSante also is developing its nanoparticulate-based platform technology (CAP) for novel vaccines, vaccine adjuvants and drug delivery systems.

For more information, call 847/793-2458.
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Publication:Biotech Business
Date:Jul 1, 2001
Words:426
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