BioDelivery Sciences International and Arcion Therapeutics have signed a worldwide licensing deal for the development and commercialization of topical clonidine gel (previously ARC4558) to treat painful diabetic neuropathy (PDN) and other indications.
Arcion developed the patented topical gel formulation of clonidine, that is believed to play a vital role in stimulating an inhibitory receptor in the skin connected with pain fibers.
A Phase 2 study demonstrated the efficacy of the product in reducing pain in PDN, meeting the primary endpoint.
BDSI president and chief executive officer Dr. Mark Sirgo said, "Though we remain focused on preparing our BUNAVAIL NDA for filing in the coming months and completing our BEMA Buprenorphine chronic pain Phase 3 trials, this product acquisition allows us to build our pipeline, while applying our expertise in pain product development, utilizing the FDA's 505(b)(2) regulatory process, and diversifying outside of opioid therapy and our BEMA technology."
Under the deal, Arcion will gain upfront payment of $2m in the form of unregistered shares of BDSI common stock in addition to milestone payment of $2.5m in unregistered shares of BDSI stock upon FDA acceptance of new drug application (NDA) for topical clonidine gel.
Based on certain regulatory and commercial considerations, Arcion is eligible for a cash payment between $17.5m and $35m upon NDA approval.
Arcion is also entitled to receive sales-based milestones in addition to low single-digit royalties.
Arcion chief executive officer James Campbell said, "This transaction allows us to now focus our resources on our other pain programs."