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

, compared to $23.8 million in the comparable period of 2012.  This also reflects increased spending in 2013 for BDSI's Phase 3 clinical trials.  

Recently BDSI has made important personnel additions in preparation for commercialization of BUNAVAIL in 2014.  In July, BDSI announced the hiring of Adrian Hepner, MD, as Vice President of Clinical Research and Regulatory Affairs.  Dr. Hepner joined BDSI with over twenty years of experience in U.S. and international clinical research.  More recently, in October, BDSI strengthened its senior management team with the appointment of Ernest De Paolantonio as Chief Financial Officer.  Mr. De Paolantonio is an experienced industry veteran of over 35 years and has been involved in numerous product launches at GlaxoSmithKline, Watson, Columbia Laboratories, and most recently, CorePharma.     

"We are pleased with all of our third quarter accomplishments and particularly excited that the NDA for BUNAVAIL has been accepted for review, and we look forward to working with the FDA toward approval next year," said Dr. Mark A. Sirgo, President and Chief Executive Officer of BDSI.  "The opioid dependence market continues to grow, and we believe that caregivers and patients are eager to see alternatives to the currently available therapies.  We are actively exploring all aspects of our commercial plans for BUNAVAIL and expect to have additional details early next year." 

"We also look forward beginning in early 2014 to the results from our two Phase 3 pivotal trials from the BEMA Buprenorphine program for chronic pain," continued Dr. Sirgo.  "Importantly, the completion of each of these trials is associated with a guaranteed milestone payment from our commercial partner Endo.  The recent interim analyses on these two trials enhance our confidence
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SOURCE BioDelivery Sciences International, Inc.
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