"These data point to a very clear and compelling therapeutic profile and regulatory strategy as BDSI makes plans to prepare for a confirmatory Phase 2b study in the latter part of this year which would potentially lead to data availability before the end of 2014," stated Dr. Andrew Finn, Executive Vice President of Product Development at BDSI. "If this study meets its endpoint, BDSI plans to proceed with the Phase 3 placebo-controlled study in the same population."
Additional financial terms of the licensing agreement include a milestone payment to Arcion of $2.5 million in unregistered shares of BDSI stock upon acceptance by the U.S. Food and Drug Administration (FDA) of a New Drug Application (NDA) for topical clonidine gel and a cash payment to Arcion of between $17.5 and $35 million upon NDA approval, depending on certain regulatory and commercial considerations. In addition, the licensing agreement includes sales milestones and low single-digit royalties on net worldwide sales.
Dr. Sirgo concluded, "The use of our equity for initial payment combined with the success-based milestones in this agreement allows us to preserve our capital for the clinical development program, with the majority of the cost falling in 2014 and beyond."
About Painful Diabetic Neuropathy and Topical Clonidine GelNearly 26 million people in the U.S. have diabetes according to the American Diabetes Association. A substantial number of these people have neuropathy as manifest by impaired sensation and pain in the extremities, most commonly the feet. Patients with PDN often experience debilitating pain symptoms that affect day-to-day functioning and quality of life. How diabetes causes a length-dependent neuropathy is unknown. In the prior double-blind, randomized, controlled trial approximately 50% of the patients with PDN demonstrated functional nociceptors in the skin in the painful region as revealed by a response to topical capsaicin. Clonidine is thought to relieve pain by decreasing the abnormal excitability of these functional nociceptors. Currently available oral treatments are modestly effective in relieving symptoms and are limited by systemic side effects and drug interactions. There are no topical products approved for the treatment of this painful condition.