November 24, 2014
By Krystle Vermes, BioSpace.com Breaking News Staff
Trimel Pharmaceuticals Corporation, which is focused on the development and sale of products situated around respiratory health, announced today that its subsidiary has signed an agreement to release exclusive rights to Natesto. Trimel Biopharma SRL will provide an affiliate of Endo International Plc with the rights to the nasal gel in the U.S. and Mexico.
Natesto is the first and only FDA-approved testosterone nasal gel for replacement therapy in males with hypogonadism. As a result of the sale, Trimel is eligible to receive payments up to $165 million. It will receive an upfront fee of $25 million and a prepaid inventory deposit of $5 million once the deal officially closes.
“We are delighted to announce this partnership agreement with Endo as it represents another significant achievement for our company and an opportunity to capture the value we have created in developing Natesto,” said Tom Rossi, president and CEO of Trimel. “Endo is a leader in the U.S. men’s health care and urology segments, making them the ideal partner for Natesto. We look forward to working with Endo as they prepare to launch this innovative and differentiated treatment option for patients suffering from low testosterone.”
Auxilium Launches Testosterone Gel
Trimel Pharmaceuticals may be the first to launch an FDA-approved nasal gel for males with hypogonadism, but Auxilium introduced a similar product to the market back in June.
The biopharmaceutical company announced on June 11 that it would be launching a generic version of Testim, alongside its partner, Prasco LLC. This drug, which is a testosterone gel, is designed to treat males who have low or no testosterone.
“While Testim has continued to represent an important portion of Auxilium‘s net sales, we have been proactively planning for this launch in an effort to most strategically position our product franchise to compete in the increasingly crowded and challenging Testosterone Replacement Therapy gel market,” said Adrian Adams, chief executive officer and president of Auxilium. “We believe the launch of this Authorized Generic of Testim with Prasco could expand the Testim franchise market, build upon our efforts to manage Testim as a mature brand and enable Auxilium to realize maximum shareholder value.”
Testim is provided to patients after a blood test has determined that the prescription is a viable option as a result of low or no testosterone within the body.