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Adneuris Therapeutics, a wholly owned subsidiary of Tris Pharma advancing a new kind of pain medicine, has entered into an exclusive license agreement with Maruishi Pharmaceutical, a privately held, perioperative and pain-focused pharmaceutical company based in Osaka, Japan.
This agreement grants Maruishi the rights to develop and commercialise cebranopadol, Adneuris' lead investigational therapy, for the treatment of pain in Japan and South Korea.
The agreement marks Adneuris' second ex-US licensing transaction, following its agreement for Greater China, and underscores the company's vision for advancing a new era in pain medicine to treat severe pain.
Central to that strategy is cebranopadol, a first-in-class dual-NMR (nociceptin/orphanin FQ peptide (NOP) and µ-opioid peptide (MOP) receptors) agonist that has completed Phase 3 clinical development for moderate-to-severe acute pain and Phase 2 for multiple chronic pain indications. Adneuris plans to submit a New Drug Application (NDA) to the US Food and Drug Administration (FDA) later this year.
Under the terms of the agreement, Maruishi will pay Adneuris an upfront payment of $35 million, including a $10 million royalty investment. Adneuris is also eligible to receive substantial development and commercial milestone payments, plus tiered royalties on net sales in Japan and South Korea starting in the double digits. Maruishi will hold exclusive rights to develop and commercialise cebranopadol for pain in the licensed territory.