DUBLIN, Ireland — Endo International plc has purchased the rights to Natesto testosterone nasal gel from Trimel BioPharma SRL, a subsidiary of Trimel Pharmaceuticals Corp.
Endo said Monday that Natesto, approved by the Food and Drug Administration in May of 2014, is the first and only testosterone nasal gel for replacement therapy in men diagnosed with hypogonadism, a condition in which the body doesn’t produce enough testosterone.
Natesto for intranasal use comes in a metered-dose pump. One pump delivers 5.5 mg of testosterone, with recommended dose of 11 mg (one pump for each nostril) three times daily.
Under the agreement, Trimel will receive an upfront payment of $25 million and could receive additional payments for certain regulatory and sales milestones. Trimel will be responsible for the manufacture and supply of Natesto. and Endo will pay a tiered supply price for the product.
Endo receives sole and exclusive commercial rights to the Natesto product in the United States and Mexico. In addition, Endo will collaborate on all regulatory and clinical development activities in coordination with Trimel.
Endo said that it expects the transaction to close early next year.
"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," stated Rajiv De Silva, president and chief executive officer of Endo. "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."
