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BioDelivery Sciences Provides Business Review and Update in Conjunction with Filing of its 2012 Annual Report
Date:3/18/2013

xone.  In September 2012, BDSI announced a positive outcome of the pivotal pharmacokinetic study and in January 2013 announced completion of the safety study, which demonstrated favorable tolerability in 249 opioid dependent subjects switched from Suboxone to BUNAVAIL.  
  • ONSOLIS/BREAKYL.  In October, BDSI announced the commercial launch of BREAKYL (fentanyl buccal film) in the European Union.  Under the terms of its agreement with its commercial partner Meda, BDSI received a final milestone payment of $2.5 million and will also receive a royalty on net sales of BREAKYL in the E.U.  The launch of BREAKYL also triggered the recognition of $17.5 million of previously deferred revenue.
  • $40 Million Registered Financing.  In December, BDSI closed a registered direct financing (priced at market and with no warrant coverage) which yielded gross proceeds of $40 million to BDSI, of which 70% was received from current investors.  Proceeds are expected to fund the clinical programs of both BEMA Buprenorphine and BUNAVAIL while providing a strong balance sheet for potential licensing discussions for BUNAVAIL for both the U.S. and abroad or as BDSI considers commercializing BUNAVAIL on its own.
  • Anticipated 2013 Milestones

    BDSI is focusing its resources on achievement of the following key milestones:

    • Submission of BUNAVAIL NDA for opioid dependence.  Based on demonstrating bioequivalence in the pivotal pharmacokinetic study and positive results in the safety study, BDSI anticipates it will submit a New Drug Application (NDA) to the FDA for BUNAVAIL in mid-2013.
    • Recruitment of two Phase 3 studies for BEMA Buprenorphine.  BDSI and Endo expect to continue recruitment in the two Phase 3 efficacy studies for BEMA Buprenorphine for chronic pain, one in opioid experienced and one in opioid naïve patient
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    SOURCE BioDelivery Sciences International, Inc.
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