Trimel Licenses Natesto For Hypogonadism To Endo For Marketing
By Cyndi Root
Trimel Pharmaceuticals has licensed Natesto to Endo International for marketing in the U.S. and Mexico. The companies announced the deal in a press release, stating that Natesto is a nasal gel, Food and Drug Administration (FDA)-approved for men with hypogonadism to replace testosterone.
Under the terms of the agreement between Endo and Trimel, the commercialization license is exclusive to the U.S. and Mexico. Endo is to pay up to $165 million for the license, including an upfront payment of $25 million and prepaid inventory deposit of $5 million when the deal closes. Additionally, based on regulatory and sales milestones, Trimel is due additional payments. Trimel has agreed to manufacture Natesto, and Endo will pay a tiered supply price for the product.
Natesto
Natesto is an androgen that is approved to treat men with congenital or acquired primary hypogonadism or men with congenital or acquired hypogonadotropic hypogonadism. These men have a deficiency or absence of endogenous testosterone and the drug acts as replacement testosterone. The FDA approved the agent in May 2014, the first-ever nasal testosterone replacement therapy. Patients self-administer the drug through a metered dose pump applicator, which delivers 5.5 mg of testosterone per actuation. Patients take one actuation per nostril, three times daily for a total of 33 mg/day.
On the heels of its licensing agreement with Endo, Trimel announced that Mattern Pharma AG, its technology partner, was granted another United States Patent for Natesto and its proprietary nasal gel technology. Trimel now expects its four patents on the drug will qualify the agent for inclusion in the FDA’s Orange Book and patent protection until 2024. Mr. Rossi said, "This patent further strengthens our intellectual property position and provides further protection for this important product in Trimel's portfolio."
About Trimel
Trimel focuses on men's health, women's health, and respiratory medicine. In July, Trimel acquired the Canadian rights for Estrace (17-beta estradiol) from Shire. The product is a hormone replacement therapy (HRT) on the market in Canada for 39 years. Trimel also bought Shire’s inventory of Estrace.