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Sosei re-acquires rights to pain drug from Mundipharma

Sosei Group, a Japan-based biopharmaceutical company, has re-acquired the rights for commercialization of AD 923 from UK-based Mundipharma International.

Sosei has previously entered into a licensing agreement with Mundipharma, under which Mundipharma were granted the right to commercialize AD 923 in Europe and other international markets, excluding North America and Japan.

In February 2008, the program entered Phase III clinical trials in Europe. However, due to a problem concerning a supplied component in the device used to deliver the fentanyl spray, the trial was temporarily halted in March 2008.

A solution to the technical problem with the device has since been identified, but Sosei is no longer in a position financially to continue with the program and a new partner is being sought to progress clinical development.

The buyback of the Mundipharma rights now provides Sosei with the possibility of offering commercialization rights on a global basis. The Mundipharma rights are expected to be re-acquired for a mutually agreed sum of GBP2m, plus an additional 20% (up to a maximum of GBP1.5m) of net receipts if Sosei enters into a new partnership agreement involving the Mundipharma territory.

AD 923 is an optimized, sublingual formulation of the strong opioid analgesic fentanyl for the treatment of cancer breakthrough pain. It has been specifically designed to provide rapid onset of analgesia in a device that is easy to use by either the patient or their care giver, the company said.