BioDelivery Sciences has added to its pipeline of treatments for the pain market, seizing worldwide rights to an experimental topical therapy for painful diabetic neuropathy (PDN) from Arcion Therapeutics. The licensing deal gives Raleigh, N.C.-based BioDelivery ($BDSI) a candidate with peak sales potential of $300 million, according to the company.
Diabetic neuropathy is a painful problem for a growing population of diabetics, which has reached nearly 26 million people in the U.S. alone, according to the American Diabetes Association. And the idea behind BioDelivery's newly in-licensed Arcion candidate, a topical clonidine gel, is to provide patients with the pain-fighting benefits of analgesia at the site of discomfort rather than in a dose form that exposes their system to the active ingredient. Arcion has already gathered proof of its efficacy from a Phase II double-blind, placebo controlled study in PDN patients, teeing up the candidate for a Phase IIb confirmatory trial later this year.
For BioDelivery, the Arcion candidate provides the company with a promising mid-stage contender to complement a late-stage drive to advance BEMA Buprenorphine or Bunavail in partnership with Endo for combating chronic pain and a lineup of other treatments at various stages of development with its BEMA delivery tech. To gain rights to the PDN contender, BioDelivery has agreed to pay out $2 million in company stock to Arcion upfront as well as $2.5 million in BDSI stock once an NDA for the treatment candidate is accepted and between $17.5 million and $35 million in cash upon FDA approval.
"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," Dr. Mark A. Sirgo, BDSI's president and CEO, stated.
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