Licenses for Bremelanotide
Palatin exclusively licensed North American rights to develop and commercialize bremelanotide to AMAG Pharmaceuticals, Inc. (Nasdaq:AMAG). The anticipated filing date in the U.S. for a new drug application for bremelanotide, 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 bremelanotide 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 bremelanotide in 2017. AMAG will also pay Palatin tiered royalties on net sales ranging from high single-digit to low double-digit percentages.
In September 2017 we entered into a license agreement with Shanghai Fosun Pharmaceutical Industrial Development Co., Ltd. for exclusive rights to commercialize bremelanotide in the territories of mainland China, Taiwan, Hong Kong S.A.R. and Macau S.A.R. We will receive an upfront payment of $5.0 million and, when regulatory approval for a bremelanotide product is obtained in China, a $7.5 million milestone payment. We may receive up to $92.5 million in sales related milestones, and will receive high single-digit to low double-digit royalties on net sales in the licensed territories.
Palatin retains rights to bremelanotide outside North America and China, and is in active discussions with potential licensees.