Palatin Technologies, Inc. announced that Fosun Pharma, the licensee of Vyleesi in China, reported its first sale in the Hainan Province of China. Palatin also announced that their South Korean licensee, Kwangdong Pharmaceuticals, completed enrollment in its Phase 3 clinical trial evaluating the efficacy and safety of Vyleesi in premenopausal women with HSDD. Data from this trial is anticipated by year end with a potential regulatory submission in the first half of 2024.

Vyleesi is the first and only as-needed treatment approved by the U.S. Food and Drug Administration (FDA) for premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD). Vyleesi is marketed by Palatin in the U.S. and the Company recently announced its sixth consecutive quarter of double-digit growth in Vyleesi prescriptions dispensed. Fosun's first sale of Vyleesi was dispensed through a medical institution in the Hainan Province, a free trade port in China, under which certain imported pharmaceutical products can be sold in Hainan without first receiving registration approval from the Chinese National Medical Products Administration (NMPA).

The establishment of the Hainan Free Trade Zone (FTZ) is expected to further boost the medical tourism zone project and leverage market opportunities created by the growing demand for medical products and services. Kwangdong's Phase 3 study is a bridging, multicenter, randomized, double-blind, placebo-controlled, parallel-group trial to evaluate the efficacy and safety of subcutaneously injected bremelanotide in premenopausal women with hypoactive sexual desire disorder (with or without decreased arousal). The study enrolled 193 patients with 180 or 93% completing the study.

Results of the study are currently expected later this year and the data will support a potential first-half 2024 submission to the Korean Ministry of Food & Drug Safety (MFDS) for potential marketing approval. Under the terms of the 2017 agreement with Fosun, Palatin granted Fosun an exclusive license to develop and commercialize bremelanotide (Vyleesi) in the territories of mainland China, Taiwan, Hong Kong and Macau. Palatin received an upfront payment of $5.0 million and is due a $7.5 million milestone based on regulatory approval by the Chinese National Medical Products Administration (NMPA).

Palatin has the potential to receive up to $92.5 million in sales related milestones and high single-digit to low double-digit royalties on annual net sales in the licensed territory. All development, regulatory, sales, marketing, and commercial activities and associated costs in the licensed territory are the sole responsibility of Fosun. Under the terms of the 2017 agreement with Kwangdong, Palatin granted Kwangdong an exclusive license to develop and commercialize bremelanotide (Vyleesi) in the Republic of Korea for HSDD/FSD.

Kwangdong is responsible for all regulatory and other development and clinical activities necessary for commercialization in the Republic of Korea. In exchange, Palatin received an upfront payment of $500,000 and is due a $3.0 million milestone based on the first commercial sale in Korea. Palatin has the potential to receive up to $37.5 million in annual sales related milestones and mid-single-digit to low-double-digit royalties on net sales in the licensed territory.