AMAG Pharmaceuticals to Pay $60 Million Milestone to Palatin Technologies Following FDA Approval of Vyleesi for HSDD

VCBeat (WeChat ID: vcbeat) has learned from foreign media that the U.S. FDA has recently approved the New Drug Application (NDA) for Vyleesi, a new medication for the treatment of Hypoactive Sexual Desire Disorder (HSDD) in women. The drug was developed by Palatin Technologies under license from AMAG Pharmaceuticals, and will be marketed by AMAG Pharmaceuticals.

It is reported that this approval will trigger a $60 million milestone payment from AMAG Pharmaceuticals to Palatin Technologies. Under the agreement signed by both parties in January 2017, Palatin Technologies is also entitled to receive tiered royalties on the net sales of Vyleesi following its commercial launch. AMAG Pharmaceuticals has established milestone payment thresholds based on increasing sales volumes; the first threshold stipulates that when the annual net sales of Vyleesi reach $250 million, AMAG Pharmaceuticals will pay Palatin Technologies a $25 million milestone fee.

Hypoactive Sexual Desire Disorder (HSDD) is the most common female sexual dysfunction in the United States, characterized by markedly low sexual desire that cannot be simply attributed to existing medical, pharmacological, or psychiatric conditions. Approximately 6 million premenopausal women in the U.S. meet the diagnostic criteria for HSDD; however, only a small fraction of these women are aware of their condition, and an even smaller proportion seek relevant examination or treatment. Recent market research indicates that up to 95% of premenopausal women with HSDD are unaware that it is a treatable condition.

Vyleesi is an injectable agent (bremelanotide injection) that can be self-administered into the abdomen or thigh at least 45 minutes before sexual activity. The optimal timing of administration may also be determined based on the duration of drug effect and side effects observed in individual patients. The precise mechanism of action of this drug remains unclear; it is only known that Vyleesi binds to melanocortin receptors, which are receptors in the central nervous system associated with sexual function.

It is worth noting that women should use no more than one dose of Vyleesi per day and no more than eight doses per month. If there is no improvement in sexual desire after eight consecutive weeks of use, the medication should be discontinued immediately. Common side effects of this drug include nausea and vomiting, flushing, injection site reactions, and headache. Additionally, Vyleesi does not interact with alcohol.

“We are very excited about the FDA approval of Vyleesi for the treatment of premenopausal women with HSDD,” said Carl Spana, Chief Executive Officer of Palatin Technologies. “The FDA’s approval means that premenopausal women with HSDD now have access to a safe and effective on-demand treatment option. The approval of Vyleesi represents a significant milestone for Palatin and is the result of the collaborative efforts of the teams at Palatin and AMAG.”

“I greatly appreciate the determination demonstrated by the Palatin team in the development of Vyleesi,” said Stephen T. Wills, Chief Financial Officer of Palatin Technologies. “We have already secured licensing for Vyleesi in North America, China, and South Korea. With the recent FDA approval, we look forward to obtaining licensure for Vyleesi in other regions worldwide. Furthermore, Palatin Technologies has received a $60 million milestone payment, which will support the advancement of our ophthalmic disease R&D pipeline, including dry eye disease, non-infectious uveitis, and other inflammatory indications.”

(Compiled by: Wang Chan)