Benzinga | Dec 22, 2021 07:31AM EST

DURECT And Innocoll Announce $136M US Licensing Agreement For POSIMIR (Bupivacaine Solution); Innocoll To Make Near-Term Payments To DURECT Of $6M With Potential For $130M In Milestones

DURECT Corporation (NASDAQ:DRRX) today announced a licensing agreement granting Innocoll Biotherapeutics plc, a specialty pharmaceutical company and portfolio business of Gurnet Point Capital, exclusive development and commercialization rights to POSIMIR(r) (bupivacaine solution) for infiltration use, DURECT's FDA-approved non-opioid, sustained-release local analgesic for the treatment of post-surgical pain in adults following arthroscopic subacromial decompression surgery, in the United States.

"We are excited to license the U.S. development and commercialization rights for POSIMIR to Innocoll, whose dedicated hospital sales and marketing organization is deeply committed to providing non-opioid analgesia products to patients in the post-surgical setting," said James E. Brown, President and Chief Executive Officer of DURECT Corporation. "Completing this POSIMIR deal is another important step in the continued transformation of DURECT as we continue to focus on larsucosterol, our lead epigenetic regulator, which is in late-stage clinical development for alcohol-associated hepatitis."

"We believe that POSIMIR has the potential to become a cornerstone of multi-modal post-operative pain management as well as an important contributor to the on-going efforts to provide safe and effective alternatives to opioid-based medications following surgery," added Louis Pascarella, Chief Executive Officer of Innocoll. "Innocoll is now the only company with two bupivacaine-based, sustained-release, non-opioid products, that are FDA approved and indicated for relief of post-surgical pain in specified surgical procedures. We are currently on track to launch POSIMIR in the second quarter of 2022, subject to commercial supply timelines."

Terms of the Collaboration



Under the terms of the agreement, Innocoll will make near-term payments to DURECT of $6 million, consisting of a $4 million license fee and a $2 million payment upon first commercial sale, with the potential for up to an additional $130 million in commercial, regulatory and intellectual property milestone payments as well as tiered, low to mid double-digit royalties on net product sales in the United States.

Innocoll has been granted the exclusive right to develop and commercialize POSIMIR in the United States. Innocoll has also been granted the right to conduct additional development activities to expand the approved indications for POSIMIR, and DURECT's contract manufacturing supply agreement for POSIMIR has been assigned to Innocoll. DURECT retains all commercial rights to POSIMIR throughout the rest of the world.