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

vity of BEMA Buprenorphine and BNX through 2027, is expected by the end of second quarter 2012.  The allowance of the patent was made by the United States Patent and Trademark Office (USPTO) in February 2012, while the formal granting that triggers this milestone payment typically occurs within 3 months of the allowance.  

"The past fifteen months have been very exciting for BDSI as we have made significant progress in prudently deploying our resources and moving our company forward," said Dr. Mark A. Sirgo, President and Chief Executive Officer of BDSI.  "We are very pleased to partner with a company of the caliber of Endo Pharmaceuticals for BEMA Buprenorphine for chronic pain, with whom we are working towards initiation of two Phase 3 studies in the third quarter of this year.  With Endo's added involvement in this development program and experience in pain, we believe the probability of a positive outcome in this program is enhanced.  In addition, BEMA Buprenorphine is extremely complimentary to Endo's already impressive pain franchise and represents the only Schedule 3 opioid in their branded portfolio.  We continue to believe that BEMA Buprenorphine has the potential to achieve peak sales in excess of $500 million." 

According to Dr. Andrew Finn, Executive Vice President of Product Development, "As it relates to BNX, we began 2012 with a meeting with FDA and obtained clear guidance on this program that could lead to an NDA submission in the first half of 2013 and subsequently allow us to enter the rapidly growing market for the treatment of opioid dependence.  BNX has the opportunity to be the first branded transmucosal buprenorphine/naloxone product to compete with Suboxone, which achieved sales in excess of $1.2 billion in 2011 and continues to grow."

2011 Corporate Update

By way of review, the following are key events that occurred at BDSI over the past 15 months:


    SOURCE BioDelivery Sciences International, Inc.
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    1. MonoSol Rx, LLC Files Patent Infringement and False Marking Lawsuit Against BioDelivery Sciences International, Inc., MEDA Pharmaceuticals Inc., and Aveva Drug Delivery Systems, Inc.
    2. BioDelivery Sciences Announces BEMA Buprenorphine Phase 3 Chronic Pain Study More Than 50% Recruited and on Schedule
    3. BioDelivery Sciences Confirms 505(b)(2) Pathway for BEMA Buprenorphine/Naloxone for Opioid Dependence Following FDA Meeting
    4. BioDelivery Sciences to Present at the 23rd Annual ROTH OC Growth Stock Conference
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    11. Samuel J. Sears, Jr. Appointed to BioDelivery Sciences Board of Directors
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