Biopharmaceutical company Palatin Technologies Inc (NYSE MKT:PTN) announced Tuesday that it has entered into a collaboration and license agreement with Kwangdong Pharmaceutical Co Ltd for exclusive rights to develop and commercialise bremelanotide for female sexual dysfunction (FSD) indications in Korea.
For the Q1 of calendar year 2018, Kwangdong, based in Korea, will file A New Drug Application (NDA) for bremelanotide with the US Food and Drug Administration (FDA). Bremelanotide is thought to possess a novel mechanism of action, activating endogenous melanocortin pathways involved in sexual desire and response.
Under the terms of the agreement, Kwangdong has received the exclusive license to develop and commercialise bremelanotide in Korea for FSD from Palatin. Kwangdong will be responsible for all regulatory and other development and clinical activities necessary for commercialisation in Korea.
In conjunction with the agreement, Palatin will receive an upfront payment of USD500,000 and a USD3.0m milestone based on first commercial sale in Korea. Palatin has the potential to receive up to USD37.5m in sales related milestones and mid-single-digit to low double-digit royalties on net sales in the licensed territory.
Under the two Phase 3 studies for HSDD in pre-menopausal women, the company compared a single use, subcutaneous dose of 1.75 mg of bremelanotide versus placebo, in each case, delivered via an auto-injector. In both clinical trials, bremelanotide met the pre-specified co-primary efficacy endpoints of median improvement in desire and decrease in distress associated with low sexual desire as measured using validated patient-reported outcome instruments.
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