BioSante Pharmaceuticals' Bio-T-Gel approved by FDA
2012-02-15 12:00 ET - News Release
Mr. Stephen Simes reports
BIOSANTE PHARMACEUTICALS ANNOUNCES FDA APPROVAL FOR BIO-T-GEL LINCOLNSHIRE, ILLINOIS(FEBRUARY 15, 2012)
BioSante Pharmaceuticals, Inc.'s Bio-T-Gel, which is licensed by BioSante to Teva Pharmaceuticals USA Inc. has been approved by the United States Food and Drug Administration (FDA). Bio-T-Gel is a 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.
"We are pleased that Bio-T-Gel will provide another treatment option to men suffering from low testosterone levels," said Stephen M. Simes, BioSante's president & CEO. "We are confident that Teva has the commercialization and marketing expertise to implement a successful launch, and we look forward to Bio-T-Gel reaching the market."
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 require
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