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

ndo on BDSI's balance sheet as of December 31, 2012.  As previously reported, this deferral of revenue had no impact (and will have no impact) on BDSI's cash position or its ability to use these funds in connection with its business plans.  Further details regarding this restatement can be found in such amended Form 10-Q reports and BDSI's 2012 Form 10-K, all of which were filed with the SEC on March 18, 2013.

2012 Corporate Update

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

  • BEMA Buprenorphine - Chronic Pain.  Early in 2012, BDSI 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 and thresholds are met, resulted in the payment of a $30 million license fee at signing and $15 million in April 2012 upon the granting of a patent extending the exclusivity of BEMA products containing buprenorphine from 2020 to 2027.  The partnership also grants BDSI the potential to receive sales threshold payments as well as a tiered mid- to upper-teen royalty on net sales in the U.S. following FDA approval.  

    In August, BDSI and Endo initiated the Phase 3 clinical studies of BEMA Buprenorphine for the treatment of moderate to severe chronic pain.  Two efficacy studies, one in opioid naïve and one in opioid experienced subjects, are currently enrolling patients. 
  • BUNAVAIL - Opioid Dependence.  BUNAVAIL, formerly referred to as BEMA Buprenorphine/Naloxone or BNX, is being developed for the treatment of opioid dependence and utilizes the patented BioErodible MucoAdhesive (BEMA) technology to deliver buprenorphine combined with the opioid antagonist nalo
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SOURCE BioDelivery Sciences International, Inc.
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Related medicine technology :

1. BioDelivery Sciences Announces Positive Results from BEMA Buprenorphine/Naloxone (BNX) Pharmacokinetic Study
2. BioDelivery Sciences and Endo Health Solutions Announce Initiation of Enrollment in the Phase 3 Program for BEMA Buprenorphine for Chronic Pain
3. BioDelivery Sciences to Present at the 2012 Wedbush PacGrow Lifesciences Management Access Conference
4. BioDelivery Sciences Announces Completion of Enrollment in Pivotal Pharmacokinetic Study of BEMA Buprenorphine/Naloxone Compared to Suboxone
5. BioDelivery Sciences to Present at the Stifel Nicolaus 2012 Healthcare Conference
6. BioDelivery Sciences Announces Positive Results of Pivotal Pharmacokinetic Study Comparing BEMA Buprenorphine/Naloxone (BNX) to Suboxone
7. BioDelivery Sciences Provides Business Update and Summary of Third Quarter Results of Operations
8. BioDelivery Sciences to Present at the 24th Annual Piper Jaffray Healthcare Conference
9. BioDelivery Sciences Announces $40 Million Registered Financing
10. BioDelivery Sciences Announces Completion of BNX Safety Study
11. BioDelivery Sciences to Present at the 15th Annual BIO CEO and Investor Conference
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