Adneuris Therapeutics has granted Maruishi Pharmaceutical exclusive rights to develop and commercialise cebranopadol for pain in Japan and South Korea in a deal worth $35 million upfront.

Cebranopadol deal includes $35M upfront payment

Under the agreement, Maruishi will pay Adneuris an upfront payment of $35 million, including a $10 million US royalty investment. Adneuris is also eligible for development and commercial milestone payments, as well as tiered royalties on net sales in Japan and South Korea starting in the double digits.

The agreement gives Maruishi exclusive rights to develop and commercialise cebranopadol for pain in the two markets.

The transaction marks Adneuris’ second licensing agreement outside the US, following an earlier deal covering Greater China.

Ketan Mehta, founder and chief executive officer of Tris Pharma, the parent company of Adneuris Therapeutics, said: “Maruishi’s deep expertise in perioperative and pain management, combined with its established commercial infrastructure across Japan, make them an ideal partner to help bring cebranopadol to patients in these important markets across the globe.”

The deal adds to the commercial development of cebranopadol as Adneuris prepares for a potential US regulatory submission.

Phase 3 trials evaluated cebranopadol in acute pain

Cebranopadol is an investigational dual NOP and MOP receptor agonist that has completed Phase 3 clinical development for moderate-to-severe acute pain and Phase 2 development in several chronic pain indications.

The treatment was evaluated in two Phase 3 trials, known as Alleviate-1 and Alleviate-2, following abdominoplasty and bunionectomy respectively.

Across its broader clinical programmes, cebranopadol has been studied in more than 2,400 participants.

According to Adneuris, both Phase 3 studies showed a significant reduction in pain compared with placebo over 48 hours, alongside reduced use of opioid rescue medication and sustained pain control.

The company said the results support further development of cebranopadol as a potential treatment for acute pain. Adneuris has also positioned the drug as having a safety profile intended to reduce some of the side effects associated with conventional opioid treatments, including dependence and misuse.

The company expects to submit a New Drug Application to the US Food and Drug Administration later this year for acute pain.

Licensing expands cebranopadol development

The agreement with Maruishi gives Adneuris another commercial partner in major Asian pharmaceutical markets while leaving the company to progress cebranopadol towards its anticipated US regulatory submission.

Maruishi is focused on perioperative and pain management and will lead development and commercialisation activities in Japan and South Korea.

Katsuhito Inoue, president and representative director of Maruishi Pharmaceutical, said: “Cebranopadol’s differentiated mechanism and clinical profile suggest the potential to become an important new option for patients living with pain, and we look forward to working with Adneuris to advance its development in Japan and South Korea.”

The agreement follows growing interest in approaches to pain treatment that could provide effective analgesia while addressing some of the limitations associated with conventional opioid medicines.

For Adneuris, the transaction provides additional funding and commercial infrastructure for cebranopadol ahead of the anticipated US filing, while expanding the drug’s potential development and commercial footprint beyond the US.