RALEIGH, N.C., March 26, 2013 /PRNewswire/ -- BioDelivery Sciences International, Inc. (Nasdaq: BDSI) announced today that it has entered into a worldwide licensing agreement with privately held Arcion Therapeutics (Arcion), where BDSI will develop and commercialize topical clonidine gel (formerly ARC4558) for the treatment of painful diabetic neuropathy (PDN) and potentially other indications.
The PDN market is highly under-served by existing products and there is a strong scientific rationale for developing a topical treatment for PDN that delivers analgesia in a way that avoids systemic side effects.
Under the terms of the agreement, BDSI will make an upfront payment of $2 million to Arcion in the form of unregistered shares of BDSI common stock."We are excited about this late stage product where efficacy has already been demonstrated in a very painful condition with a significant unmet need," said Dr. Mark A. Sirgo, President and Chief Executive Officer of BDSI. "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." "BioDelivery Sciences makes a great partner for our clonidine program, providing the expertise in developing pain medications and resources to bring this program to patients," stated James Campbell, MD, Chief Executive Officer of Arcion. "This transaction allows us to now focus our resources on our other pain programs." Evidence has shown that clonidine stimulates an inhibitory receptor in the skin associated with pain fibers. Arcion has developed a patented topical gel formulation of clonidine and has assessed its effectiveness in reducing pain in PDN in a double-blind, placebo-controlled, Phase 2 study where the primary study endpoint was the change in pain intensity over a 3 month treatment period in diabetic foot pain. A significant treatment difference was seen in the planned subset analysis of diabetic patients who had documented evidence of "functioning pain receptors" in the skin of the lower leg (p=0.01, n=63) thus, at a minimum, supporting the effectiveness of topical clonidine in diabetic patients with functioning pain receptors of the skin. In the overall population that included patients without "functioning nerve receptors", there was a trend favoring topical clonidine gel (p=0.07, n= 182), though the overall results did not reach statistical significance.