Licenses for Vyleesi™ (bremelanotide)
Palatin exclusively licensed North American rights to develop and commercialize Vyleesi™, the trade name for bremelanotide, to AMAG Pharmaceuticals, Inc. (Nasdaq:AMAG). A New Drug Application for Vyleesi, an on-demand treatment for hypoactive sexual desire disorder (HSDD) in premenopausal women, was filed in the first quarter of 2018, with anticipated completion of Food and Drug Administration (FDA) review by June 23, 2019.
Under the terms of the license agreement, AMAG paid Palatin $60 million of total upfront consideration, and received a $20 million milestone payment, as adjusted, upon acceptance of the New Drug Application for review by FDA. Palatin will receive a $60 million milestone payment upon approval of Vyleesi by FDA. Palatin will also received up to $300 million contingent upon meeting certain sales milestones. The first sales milestone is $25 million and would be triggered when Vyleesi annual net sales in North America exceed $250 million. Additionally, AMAG reimbursed Palatin for up to $25 million of ongoing development expenses incurred by Palatin, less certain expenses paid by AMAG, in connection with the remaining development of Vyleesi 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 Vyleesi in the territories of mainland China, Taiwan, Hong Kong S.A.R. and Macau S.A.R. We received an upfront payment of $5.0 million and, when regulatory approval for a Vyleesi 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. In November 2017 we entered into a license agreement with Kwangdong Pharmaceutical Co., Ltd. for exclusive rights to commercialize Vyleesi in The Republic of Korea.
Palatin retains rights to Vyleesi outside North America, China and Korea, and is in active discussions with potential licensees.