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BioDelivery Sciences Provides Business Update and Summary of Third Quarter Results of Operations
Date:11/8/2012

RALEIGH, N.C., Nov. 8, 2012 /PRNewswire/ -- BioDelivery Sciences International, Inc. (NASDAQ: BDSI) announced that it has filed its Quarterly Report on Form 10-Q for the quarter ended September 30, 2012, with the U.S. Securities and Exchange Commission and, in connection therewith, is providing a review of the Company's recent achievements and upcoming milestones. 

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"This has been a year of remarkable progress, having made key strides with our lead product candidates - BEMA Buprenorphine for the treatment of chronic pain and BNX for the treatment of opioid dependence," said Dr. Mark A. Sirgo, President and Chief Executive Officer of BDSI.  "In conjunction with our partner, Endo Health Solutions, in July we initiated two pivotal Phase 3 trials of BEMA Buprenorphine for the treatment of moderate to severe chronic pain.  As we have previously stated, we believe this is a product that has the opportunity to reach $500 million in projected peak annual sales in the U.S."

"In September we announced positive data from our pivotal pharmacokinetic study of BNX for the maintenance treatment of opioid dependence," continued Dr. Sirgo.  "We expect this to lead to an NDA filing for BNX in the latter part of the second quarter of next year.  Importantly, we have the opportunity to be the next branded buprenorphine/naloxone film to compete against Suboxone in the rapidly growing opioid dependence market, where Suboxone sales surpassed $1.5 billion in the last twelve months.  In addition, we believe that with the announced withdrawal of Suboxone tablets from the marketplace, which would leave only Reckitt's film product in the market, our BNX sales could expand beyond our current forecast of $300 million in
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SOURCE BioDelivery Sciences International, Inc.
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