Endo Acquires Testosterone Nasal Gel From Trimel Pharma

Endo announced that it has completed the acquisition of Nasteo, a testosterone nasal gel from Trimel Pharmaceuticals in a deal worth over $25 million. The new product joins Endo’s existing portfolio of men’s health treatments.

The licensing deal stipulates that the two companies will work together on all clinical development and regulatory processes. Endo gains all marketing rights in both the U.S. and Mexico.

Nasteo is an androgen indicated for the treatment of males with primary hypogonadism and hypogonadotropic hypogonadism. The medication is administered into each nostril, three times per day.

In November, Trimel announced that its proprietary nasal gel technology had been granted U.S. patent protection, which would cover the novel delivery method until 2024.

Nasteo would represent the fourth hypogonadism treatment developed or acquired by Endo in the last year. When Endo closed the deal to acquire Auxilium in October, it gained the licenses for both Testim and Testopel, two drugs that generated a combined sales of $271 million in 2013.

In Endo’s press release, Rajiv De Silva expressed Endo’s desire to offer multiple options for men seeking testosterone replacement therapy and his hopes to get Nasteo to market as quickly as possible.

In a study published by the International Journal of Clinical Practice, researchers estimated that 39 percent of men over the age of 45 have hypogonadism, but many are not aware of it. The condition may present in a variety of ways, including decreased libido, erectile dysfunction, loss of body and facial hair, fatigue, and anemia.

This study found a higher incidence of hypogonadism among men suffering from hyperlipidemia, diabetes, obesity, prostate disease, asthma, and pulmonary disease. The researchers concluded that the correlation between low testosterone and these conditions was not exact but was significant enough to merit further research.

Recently, testosterone-enhancing drugs have been the subject of controversy, and the FDA is expected to severely limit approvals granted for testosterone drugs and carefully monitor associated advertising, according to The New York Times.

Because of health risk of both heart attack and stroke, the FDA does not recommend testosterone treatment for men without an associated medical condition. The precise safety of such treatments is still the subject of considerable study.

Nasteo is currently slated for an early 2015 launch.