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

ringement lawsuit served against BDSI and its partners for ONSOLIS by MonoSol Rx, LLC (MonoSol).  MonoSol's assertion of patent infringement relate to BDSI's confidential, proprietary manufacturing process for ONSOLIS, which is kept by BDSI as a trade secret.  BDSI submitted requests for reexamination by the USPTO of the three patents MonoSol asserted against BDSI.  In November 2011, the USPTO notified BDSI that it had rejected all 191 claims of the first asserted patent (the '588 patent).  That was followed in February 2012 by rejection of all claims in the second asserted patent (the '292 patent), and finally in March 2012, the USPTO notified BDSI of rejection of all claims in the third asserted patent (the '891 patent).  In total, all claims in multiple patents (in this case three totaling 222 claims) were rejected by the USPTO.  As a result of the USPTO action, the judge has placed a stay on further litigation pending a final judgment by the USPTO.  BDSI intends to continue its aggressive defense of this matter to what BDSI believes will be a positive resolution for the company.

Anticipated 2012 Milestones

In 2012, BDSI is focusing its resources on achievement of the following key milestones:

  • Initiation of two Phase 3 Studies for BEMA Buprenorphine.  In the third quarter of 2012, BDSI expects to initiate two Phase 3 efficacy studies for BEMA Buprenorphine for chronic lower back pain, one in opioid experienced and one in opioid naive patient groups.  
  • BNX registration studies begin.  BDSI will work to advance the development of BNX for the treatment of opioid dependence through completion of the pivotal pharmacokinetic study and initiation of the safety study, allowing for a potential NDA submission in the first half of 2013. The data from the pivotal pharmacokinetic study is anticipated in late third quarter of 2012. '/>"/>

SOURCE BioDelivery Sciences International, Inc.
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Related medicine technology :

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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