as per Endo International PLC Endo International PLC has acquired rights to Natesto (testosterone nasal gel), the first and only testosterone nasal gel for replacement therapy in adult males diagnosed with hypogonadism, from Trimel BioPharma SRL, a wholly owned subsidiary of Trimel Pharmaceuticals Corp. Natesto was approved by the U.S. Food and Drug Administration in May of 2014.
Under the terms of the agreement Trimel will receive an upfront payment of $25-million and could receive additional payments upon the achievement of certain regulatory and sales milestones. Additionally, Trimel will be responsible for the manufacture and supply of Natesto and Endo will pay a tiered supply price for the product. Endo expects the transaction to close in early 2015.
"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," said 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."
Under the terms of the agreement, Endo receives sole and exclusive commercial rights to the Natesto product in the U.S. and Mexico. In addition, Endo will collaborate on all regulatory and clinical development activities in co-ordination with Trimel.