Saturday 25 February 2012

BioSante Pharmaceuticals Announces FDA Approval for Bio-T-Gel

Company: BioSante Pharmaceuticals, Inc. and Teva Pharmaceuticals USA, Inc.
Date of Approval: February 14, 2012
Treatment for: Hypogonadism -- Male
Bio-T-Gel (testosterone) is a once-daily transdermal testosterone gel for the treatment of male hypogonadism or low testosterone levels.

Male hypogonadism is generally characterized by impotence, a lack of sex drive, muscle weakness and osteoporosis.

Bio-T-Gel was initially developed by BioSante, and then it was licensed to Teva for late stage clinical development. Teva is responsible for all Bio-T-Gel regulatory and marketing activities. BioSante will receive royalties and may receive certain milestone payments upon commercialization of Bio-T-Gel. The current U.S. market for male testosterone products is estimated at over $1.6 billion.

About Male Hypogonadism

Typically, a man's testosterone level is considered low if it's below a level of approximately 300 ng/dL. Low testosterone affects 4 to 5 million men over the age of 39 and is associated with a multitude of symptoms including loss of libido and sexual function, decreased energy, increased body fat, osteoporosis, reduced muscle mass, and loss of body hair. There is no cure for hypogonadism. It is a medical condition that usually requires ongoing treatment.

About BioSante Pharmaceuticals, Inc.

BioSante is a specialty pharmaceutical company focused on developing products for female sexual health and oncology. BioSante's products include LibiGel® (transdermal testosterone gel) for the treatment of female sexual dysfunction (FSD), specifically hypoactive sexual desire disorder (HSDD), which is in Phase III clinical development. BioSante also is developing a portfolio of cancer vaccines, with 17 Phase I and Phase II clinical trials currently on-going. Four of these vaccines have been granted Orphan Drug designation by the U.S. Food and Drug Administration (FDA).
The Pill-Plus™, an oral contraceptive in Phase II clinical development by Pantarhei Bioscience B.V. BioSante's first FDA-approved product is Elestrin™ (estradiol gel) indicated for the treatment of hot flashes associated with menopause, marketed in the U.S. by Jazz Pharmaceuticals, BioSante's licensee. Additional information is available online at: www.biosantepharma.com.

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