Date: 2017-02-03
Type of information: Licensing agreement
Compound: Rekynda™ (bremelanotide)
Company: Amag Pharmaceuticals (USA - MA) Palatin Technologies (USA - NJ)
Therapeutic area: Women health
Type agreement: licensing
Action mechanism: peptide/melanocortin agonist. Bremelanotide is a melanocortin agonist drug candidate. This synthetic peptide is an analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone). It is thought to possess a novel mechanism of action, activating endogenous melanocortin pathways involved in sexual desire and response.
Disease: hypoactive sexual desire disorder (HSDD) in pre-menopausal women
Details:
- • On February 3, 2017, Amag Pharmaceuticals announced the closing of the licensing agreement with Palatin Technologies for exclusive North American commercial rights to Rekynda™ (bremelanotide), an investigational product developed for on-demand treatment of hypoactive sexual desire disorder (HSDD) in pre-menopausal women.
- • On January 9, 2017, Amag Pharmaceuticals and Palatin Technologies announced they have entered into an agreement for exclusive North American rights to develop and commercialize Rekynda™ (bremelanotide), an investigational product designed for on-demand treatment of hypoactive sexual desire disorder (HSDD) in pre-menopausal women, that has successfully completed two Phase 3 trials. The anticipated filing date in the U.S. for a new drug application (NDA) for Rekynda™ is in early 2018, with an anticipated approval and launch by early 2019.
- The two Phase 3 studies for HSDD in pre-menopausal women consisted of double-blind placebo-controlled, randomized parallel group studies comparing a subcutaneous dose of 1.75 mg Rekynda™ delivered via an auto-injector pen to placebo. Each trial consisted of more than 600 patients randomized in a 1:1 ratio to either the treatment arm or placebo with a 24 week evaluation period. In both clinical trials, Rekynda™ met the pre-specified co-primary efficacy endpoints of improvement in desire and decrease in distress associated with low sexual desire as measured using validated patient-reported outcome instruments. Women in the trials had the option, after completion of the trial, to continue in an ongoing open-label safety extension study for an additional 12 months. Nearly 80% of patients elected to remain in the open-label portion of the study, and all of these patients will continue to receive Rekynda™. In both Phase 2 and Phase 3 clinical trials, the most frequent adverse events were nausea, flushing, and headache (generally mild in nature).
Financial terms:
- Under the terms of the license agreement, Amag Pharmaceuticals will pay to Palatin $60 million of total upfront consideration, 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 expects to 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.
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