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

macokinetic study versus Suboxone are due in late third quarter of this year.
  • Endo License and Development Agreement.  Signed a worldwide license and development agreement with Endo for the exclusive rights to develop and commercialize BEMA Buprenorphine for the treatment of chronic pain.  The agreement, worth up to $180 million to BDSI if all milestones are met, included an upfront payment of $30 million at signing and a tiered mid to upper-teen royalty on net sales in the U.S.
  • BEMA Exclusivity Patent.  Allowance by the U.S. Patent and Trademark Office (USPTO) of a patent application extending the exclusivity of the BioErodible MucoAdhesive (BEMA) technology for BEMA products containing buprenorphine from 2020 to 2027.  Upon final granting, expected in the second quarter of 2012, BDSI will receive a milestone payment from Endo in the amount of $15 million.
  • ONSOLIS.  Achieved commercial launch and availability of ONSOLIS in Canada during third quarter of 2011 and regulatory submissions in Taiwan and Australia.  On December 29, 2011, the U.S. Food and Drug Administration (FDA) approved a class-wide REMS program covering all transmucosal fentanyl products.  The program, referred to as the Transmucosal Immediate Release Fentanyl (TIRF) REMS Access Program, puts in place one common REMS program and ends the disparity in prescribing requirements for ONSOLIS.  However, on March 12, 2012, BDSI announced that a U.S. re-launch of ONSOLIS would be delayed until the product formulation can be modified to address certain appearance issues recently noted by FDA.  BDSI believes that such appearance issues do not affect the product's underlying integrity or safety, has identified the cause of such issues and will work with its commercial partners and FDA to address the concerns.
  • MonoSol Litigation.  Significant progress was made in defense of the process patent inf
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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
    5. BioDelivery Sciences Announces Completion of Recruitment in BEMA Buprenorphine Phase 3 Chronic Pain Study
    6. BioDelivery Sciences Provides Update on Status of Modified REMS Program for ONSOLIS
    7. BioDelivery Sciences to Present at the Jeffries Global Healthcare Conference
    8. BioDelivery Sciences Announces Commercial Launch of ONSOLIS in Canada
    9. BioDelivery Sciences Announces Upcoming Presentations at Three Investor Conferences
    10. BioDelivery Sciences Announces Positive Results Supporting BEMA Buprenorphine/Naloxone Formulation for Opioid Dependence
    11. Samuel J. Sears, Jr. Appointed to BioDelivery Sciences Board of Directors
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