Endo announces commercial availability of NATESTO nasal gel for men with hypogonadism

Commercial launch expands Endo's growing branded pharmaceutical men's health portfolio

Endo Pharmaceuticals Inc., a subsidiary of Endo International plc (NASDAQ: ENDP) (TSX: ENL), announced today the commercial availability of NATESTO™ (testosterone nasal gel), the first and only nasal gel for testosterone replacement therapy in adult males diagnosed with hypogonadism.

NATESTO™ was approved by the U.S. Food and Drug Administration (FDA) in May 2014 for replacement therapy in adult men with conditions associated with deficiency or absence of endogenous testosterone, including primary hypogonadism (congenital or acquired) or hypogonadotropic hypogonadism (congenital or acquired). NATESTO™ reduces the risk of transference via intranasal application.

"The launch of NATESTO™ further expands Endo's branded portfolio of men's health treatment offerings and highlights our continuing commitment to ensuring that patients living with hypogonadism have access to high quality medicines," said Rajiv De Silva, President and CEO of Endo. "With testosterone gels, implantable testosterone pellets, a long-acting injectable, and now an intranasal gel, Endo offers healthcare professionals a broad range of delivery options to appropriately raise testosterone levels that help meet the individual needs of men living with hypogonadism."

In 2014, Endo acquired the rights to NATESTO™ in the U.S. and Mexico from Trimel BioPharma SRL, a wholly-owned subsidiary of Trimel Pharmaceuticals Corporation (TSX: TRL), for $25 million plus additional payments upon the achievement of certain regulatory and sales milestones. Endo will collaborate with Trimel on all regulatory and clinical development activities regarding NATESTO™.


Endo International plc


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