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BioDelivery Sciences Provides Business Review and Update in Conjunction with Filing of its Second Quarter 2012 Financials
Date:8/9/2012

ve into pivotal registration trials," said Dr. Mark A. Sirgo, President and Chief Executive Officer of BDSI.  "We announced a number of exciting achievements in the first quarter of this year, including the signing of the licensing and development agreement for BEMA Buprenorphine with Endo and a positive meeting with FDA on our BNX development program.  Since the first quarter, we have built on these prior accomplishments by progressing both BEMA Buprenorphine and BNX into registration studies.  These are significant achievements and have ushered in a very exciting period of time at BDSI.  As it relates to the BNX clinical development program, we look forward to the availability of data from our pivotal pharmacokinetic study in late September." 

Corporate Update

The following are key events that occurred at BDSI since the start of the second quarter of 2012:

  • BEMA Buprenorphine - Chronic Pain.  BDSI and Endo announced the initiation of the Phase 3 clinical program for BEMA Buprenorphine for the treatment of moderate to severe chronic pain.  The Phase 3 program will consist of two efficacy studies, one in opioid naïve and one in opioid experienced subjects.  Both studies are anticipated to be completed by late 2013 or early 2014.  Both are double-blind, randomized, placebo-controlled, enriched-enrollment studies in patients with chronic lower back pain.

    Based on the licensing agreement for BEMA Buprenorphine, BDSI will receive milestone payments from Endo at completion of study enrollment and database lock for each trial, and subsequently, for the acceptance of filing of the New Drug Application (NDA) by the FDA.  These payments will total $30 million. 

    In January 2012, BDSI signed a worldwide license and development agreement with Endo for the exclusive rights to develop and commercialize BEMA Buprenorphine for the treatment
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SOURCE BioDelivery Sciences International, Inc.
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