North American License for Rekynda
Palatin exclusively licensed North American rights to develop and commercialize Rekynda™ (bremelanotide) to AMAG Pharmaceuticals, Inc. (Nasdaq:AMAG). The anticipated filing date in the U.S. for a new drug application for Rekynda, an on-demand treatment for hypoactive sexual desire disorder (HSDD) in premenopausal women, is early 2018, with an anticipated approval and launch by early 2019.
Under the terms of the license agreement, AMAG paid Palatin $60 million of total upfront consideration, and will pay up to $80 million contingent upon achieving certain regulatory milestones and up to $300 million contingent upon meeting certain sales milestones. The first sales milestone is $25 million and would be triggered when Rekynda annual net sales in North America exceed $250 million. Additionally, AMAG will reimburse Palatin for up to $25 million of ongoing development expenses incurred by Palatin in connection with the remaining development of Rekynda in 2017. AMAG will also pay Palatin tiered royalties on net sales ranging from high single-digit to low double-digit percentages.
Palatin retains rights to Rekynda outside North America and is actively seeking licensees.