26 March 2018 - Palatin Technologies announced today that its exclusive North American licensee for bremelanotide, AMAG Pharmaceuticals, has submitted a new drug application to the U.S. FDA for bremelanotide for the treatment of hypoactive sexual desire disorder in pre-menopausal women. 

 If approved, bremelanotide would become the first and only as desired pharmacologic option in the U.S. indicated for the treatment of hypoactive sexual desire disorder (HSDD) in premenopausal women.

Palatin previously announced positive results for two Phase 3 trials of bremelanotide for the treatment of HSDD in premenopausal women that met the pre-specified co-primary efficacy endpoints. Palatin's license agreement with AMAG Pharmaceuticals, Inc. grants AMAG exclusive North American rights to develop and commercialize bremelanotide. Under the terms of the agreement, Palatin will receive up to $80 million contingent upon achieving certain regulatory milestones, including acceptance of the NDA by the FDA, and up to $300 million contingent upon meeting certain sales milestones. Palatin is also entitled to receive tiered royalties on net sales ranging from high single-digit to low double-digit percentages.

Read Palatin Technologies press release