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

year, we have made remarkable progress, executing a timely and very productive partnership with Endo worth up to $180 million for BEMA Buprenorphine and initiating two Phase 3 studies for chronic pain, as well as reporting positive data from our key bioequivalence and safety studies for BUNAVAIL for the treatment of opioid dependence," said Dr. Mark A. Sirgo , President and Chief Executive Officer of BDSI. 

"Additionally, we completed a $40 million registered financing which will assist in funding the clinical trial programs for both BEMA Buprenorphine and BUNAVAIL, while also providing a strong balance sheet as we continue BUNAVAIL licensing discussions in the U.S. and abroad and consider commercializing BUNAVAIL ourselves.  We look forward to an exciting 2013 and working to achieve a number of key milestones, including the anticipated mid-year filing of our NDA for BUNAVAIL and moving the Phase 3 studies for BEMA Buprenorphine for chronic pain toward completion.  We will also be determining whether to move forward with commercializing BUNAVAIL on our own or through a commercial partnership here in the U.S.," concluded Dr. Sirgo.

Concurrently with the filing of its 2012 10-K, BDSI also took steps to complete its previously announced restatement of its 2012 quarter financial statements to properly account for the $30 million non-refundable upfront license fee received by BDSI in January 2012 under its license and development agreement with Endo.  To this end, BDSI has filed three amended Form 10-Q reports for 2012 to reflect the deferral of recognition as revenue of approximately $14.4 million of such $30 million payment over the period during which BDSI is expected to perform clinical development services under its Endo agreement.  Approximately $5.2 million of such deferred amount was actually recognized as revenue during 2012, leaving approximately $9.2 million of deferred revenue related to E
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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
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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
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11. BioDelivery Sciences to Present at the 15th Annual BIO CEO and Investor Conference
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