Lipocine Inc. (www.lipocine.com) announced today the receipt of a $2 million development milestone payment from Abbott under the terms of its Licensing Agreement to develop and commercialize an oral testosterone product for hypogonadism, also known as low testosterone (low T).
“We are pleased with the progress of the joint development program and look forward to a productive relationship with Abbott. An oral product has the potential to be the next major innovation in the management of low testosterone”
Lipocine licensed a patented investigational oral testosterone product to Solvay Pharmaceuticals (now part of Abbott, the global health care company) in May 2009. Under the terms of the Agreement, Abbott is to make milestone payments and pay royalties to Lipocine based upon product sales. Abbott is responsible for all development expenses associated with this program, which is currently in Phase I development.
"We are pleased with the progress of the joint development program and look forward to a productive relationship with Abbott. An oral product has the potential to be the next major innovation in the management of low testosterone," said Dr. Mahesh Patel, President and CEO, Lipocine Inc. "Through improved patient compliance an oral testosterone product is expected to significantly expand options for doctors and patients in management of low testosterone."
It is estimated that hypogonadism, also known as low testosterone, affects more than 13 million men in the United States age 45 and older. Because signs and symptoms of low testosterone are subtle and often overlap with other common medical conditions, low testosterone is frequently undiagnosed.
As evidenced by the substantial recent expansion of testosterone market nearing $1B in the US there is an increased awareness of hypogonadism. Signs and symptoms of low testosterone may include low sex drive, erectile dysfunction, fatigue, depressed mood, reduced muscle mass and strength, increased fat body mass and decreased bone mineral density.