AMAG Pharmaceuticals, Inc. together with Palatin Technologies, Inc. announced they have entered into an agreement for exclusive North American rights to develop and commercialize RekyndaTM (bremelanotide), an investigational product designed for on-demand treatment of hypoactive sexual desire disorder (HSDD) in pre-menopausal women, that has successfully completed two Phase 3 trials. The anticipated filing date in the U.S. for a new drug application (NDA) for Rekynda is in early 2018, with an anticipated approval and launch by early 2019. HSDD can significantly impact self-image, relationships and the general well-being of millions of women. HSDD, the most common type of female sexual dysfunction (FSD), is characterized by low sexual desire that causes marked distress or interpersonal difficulties. HSDD affects approximately 15 million women in the United States. Approximately 5.8 million of these women are pre-menopausal and have a primary diagnosis of HSDD. Despite one HSDD therapy on the market for pre-menopausal women, patient awareness and understanding of the condition remain extremely low, and few women currently seek treatment. Recent market research indicates that 95% of pre-menopausal women suffering from HSDD are unaware that it is a treatable medical condition and that the majority of these women would try a product like Rekynda, if recommended by their doctor. Under the terms of the license agreement, AMAG will pay to Palatin $60 million of total upfront consideration, up to $80 million contingent upon achieving certain regulatory milestones and up to $300 million contingent upon meeting certain sales milestones. AMAG will also pay Palatin tiered royalties on net sales ranging from high single-digit to low double-digit percentages. AMAG expects the transaction to close in the first quarter of 2017.