Natesto, approved by the U.S. Food and Drug Administration (FDA) earlier this year, is an androgen that can be used as a therapy for patients suffering from a deficit or absence of endogenous testosterone, such as congenital or acquired hypogonadism and/or congenital or acquired hypogonadotropic hypogonadism, two conditions in which there is a decrease in either or both of the two major functions of the testes: sperm production and/or testosterone production. These abnormalities can result from disease of the testes or disease of the pituitary or hypothalamus.
In previous studies, a link between prostate cancer and hypogonadism was found. For example, in a study published in the Urology journal, researchers observed that prostate cancer was present in more than 1 of 7 hypogonadal men with levels of prostate specific antigen (PSA) of 4.0 ng/mL or less. Overall they found that severe reductions in testosterone were associated with an increased risk of prostate cancer.
“We are pleased to acquire the rights to Natesto™ to further enhance our branded pharmaceutical portfolio and look forward to leveraging our commercial expertise in the areas of men’s health and urology to support this highly differentiated product,” Rajiv De Silva, President and CEO of Endo said in a press release. “Natesto™ offers a unique intranasal delivery system which will expand options for appropriate patients seeking testosterone replacement therapy and we are focused on getting Natesto™ to market as expeditiously as possible.”
The agreement sates that Trimel shall receive an initial payment of $25 million, and after achieving specific milestones, it may receive additional payments.
Furthermore, Trimel will manufacture and supply Natesto, while Endo will get the exclusive commercial rights to the drug in the US and Mexico.
Importantly, the agreement states that both Endo and Trimel will collaborate in the necessary clinical development and regulatory activities.