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BioDelivery Sciences Provides Business Review and Update in Conjunction with Filing of Third Quarter 2013 Financials
Date:11/12/2013

in the outcome of this clinical program, and we believe the market opportunities continue to expand for a novel Schedule 3 opioid like buprenorphine."

"Finally, with our BUNAVAIL clinical program complete and our BEMA Buprenorphine chronic pain program winding down, we anticipate that our research and development spending for the remainder of 2013 and for 2014 will be reduced substantially.  This spending reduction, along with the guaranteed Endo milestones, will give us sufficient cash runway to reach BUNAVAIL revenue, which would be expected in the third quarter of 2014 assuming a June 2014 approval.  This would leave us cash flow positive at the end of 2014.  Needless to say, we have a very exciting 12 months in front of us with some very important catalysts," concluded Dr. Sirgo.

Anticipated 2013/2014 Milestones

BDSI is focusing its resources on achievement of the following key milestones:

  • BUNAVAIL NDA. Based on timelines established by the Prescription Drug User Fee Act (PDUFA), the review of the BUNAVAIL NDA is expected to be completed by June 7, 2014.
  • Milestone Payments and Phase 3 study results for BEMA Buprenorphine.  BDSI and Endo expect data from the opioid naive Phase 3 study to report out in early-2014 with the opioid experienced trial to report out in mid-2014.  Upon completion of study enrollment and database lock for each trial and the acceptance of filing of the NDA with the FDA, BDSI is expected to receive milestone payments from Endo totaling $30 million. 
  • Initiation of Confirmatory Phase 2B Study for Clonidine Topical Gel.  BDSI plans to initiate a Phase 2B study of Clonidine Topical Gel for the treatment of painful diabetic neuropathy in the first quarter of 2014.   This study could complete in 2014.

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