BioSante Pharmaceuticals, Inc. announced that a New Drug Application (NDA) has been accepted for filing by the US Food and Drug Administration (FDA) following submission in January 2011 by a subsidiary of Teva Pharmaceutical Industries Ltd. The FDA has assigned a PDUFA date of November 14, 2011. The PDUFA date is the target date for the FDA to complete its review of the NDA.
Bio-T-Gel is a testosterone gel for the treatment of male hypogonadism or low testosterone levels. Bio-T-Gel was developed initially 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 certain milestone payments and royalties upon commercialization. The current US market for male testosterone products is over $1.2 billion.
“We are extremely excited by Teva's NDA filing of Bio-T-Gel,” said Stephen M Simes, BioSante's president & CEO. “We are confident that Teva has the expertise and resources to capture significant market share once Bio-T-Gel is launched. We look forward to receiving milestone payments and royalties on Bio-T-Gel after approval and launch.”
Typically, a man's testosterone level is considered low if it's below a level of approximately 300 ng/dL. Low testosterone can be caused by a signalling problem that occurs between the brain and the testes that causes the production of testosterone to drop below normal. Low testosterone also can occur when the body can't make normal levels of testosterone and can lead to a medical condition known as hypogonadism that has many symptoms including fatigue, decreased energy, reduced sexual desire and depressed mood.
It is estimated that low testosterone affects more than 4 to 5 million men in the US. Common symptoms include reduced sex drive, decreased energy, loss of body hair or reduced shaving, and depressed mood. There is no cure for hypogonadism. It is a medical condition that usually requires ongoing treatment.
BioSante is a specialty pharmaceutical company focused on developing products for female sexual health and oncology.