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BioDelivery Sciences Provides Business Review and Update in Conjunction with Filing of its Annual Report
Date:3/19/2012

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  • Launch of BREAKYL in Europe.  BDSI expects its commercial partner, Meda, to launch BREAKYL (brand name for ONSOLIS in the E.U.) in the E.U. during the second half of 2012, which would result in a milestone payment to BDSI of $5 million.
  • Reformulation of ONSOLIS for U.S. Market.  BDSI will work with FDA and Meda to address the appearances issues noted by FDA with the aim of re-launching the product in the U.S. under a class-wide REMS program.  BDSI will provide updates on the timing for these efforts as information is available.
  • "We look forward to another exciting year ahead and thank our shareholders for their continued support," said Dr. Sirgo.  "Our product pipeline is strong as we move into 2012, behind the aggressive development of BEMA Buprenorphine and BNX in the substantial and growing pain and opioid dependence markets.  Our licensing deal with Endo offers great promise for the future of BEMA Buprenorphine and its role in the treatment of chronic pain, and we continue to believe that there remains significant upside potential in the treatment of opioid dependence, where we have the opportunity to be the next branded transmucosal buprenorphine/naloxone product to reach the rapidly growing opioid dependence market.  We believe there is a significant opportunity to enhance the value of the company this year behind the continued progress of our key assets, BEMA Buprenorphine and BNX."

    About BioDelivery Sciences International

    BioDelivery Sciences International (NASDAQ: BDSI) is a specialty pharmaceutical company that is leveraging its novel and proprietary patented drug delivery technologies to develop and commercialize, either on its own or in partnerships with third parties, new applications of proven therapeutics.  BDSI is focusing on developing products to meet unmet patient nee
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    SOURCE BioDelivery Sciences International, Inc.
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