FDA-approved product further expands Endo's Branded Pharmaceutical Men's Health portfolio
Endo International plc (NASDAQ: ENDP) (TSX: ENL), announced today the acquisition of 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 Corporation (TSX: TRL). Natesto™ was approved by the U.S. Food and Drug Administration (FDA) 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 CEO 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 US and Mexico. In addition, Endo will collaborate on all regulatory and clinical development activities in coordination with Trimel.