BDSI provides update on product portfolio, key upcoming milestones

BioDelivery Sciences International, Inc.Feb 28 2010

BioDelivery Sciences International, Inc. (Nasdaq: BDSI) today provided a summary of its business overview webcast that was conducted on Thursday, February 25, 2010. Dr. Mark A. Sirgo, President and Chief Executive Officer, and Dr. Andrew L. Finn, Executive Vice President of Product Development, provided an update on the product portfolio, including development plans, anticipated timelines, and key upcoming milestones.

Also announced were additional results of BDSI’s Phase 2 clinical study with BEMA Buprenorphine for the treatment of pain following third molar extraction (dental surgery). Initial Phase 2 results, which met the primary endpoint, were announced by BDSI in December 2009. Further analysis of the Phase 2 data has revealed a more robust effect of BEMA Buprenorphine on the primary outcome measure, SPID 8 (sum of pain intensity differences at 8 hours), in patients with more severe pain at baseline (pain score of 7 or greater). In this subset of the data, all three doses (low, medium, and high) of BEMA Buprenorphine were nearly or actually statistically superior>

Management also discussed plans for the development of a “high dose” formulation of buprenorphine with naloxone (opioid antagonist) for the treatment of opioid dependence. Management stated its belief that a BEMA formulation may be able to address some of the drawbacks associated with the currently marketed formulation of buprenorphine/naloxone, Suboxone, which reported retail sales of nearly $900 million in 2009.

The webcast also included updates on other potential near-term value drivers for BDSI, including:

• Anticipated growth of ONSOLIS sales, particularly once competitors’ REMS programs are approved and in place.
• Anticipated approvals of ONSOLIS in the E.U., which would result in the receipt of a $5 million milestone payment to BDSI.
• Canadian regulatory authority approval of ONSOLIS, making it the first approved treatment for breakthrough cancer pain in Canada.
• Clinical plans with the potential for three products to enter Phase 3 development in early 201l - BEMA Buprenorphine (pain), BEMA Buprenorphine (opioid dependence) and BEMA Granisetron (nausea/vomiting).
• The potential for a BEMA Buprenorphine commercial partnership by the end of 2010.

In closing, Dr. Sirgo stated, “2009 was the best year this company has had, led by the approval and launch of ONSOLIS. We believe the future is extremely bright, not only with ONSOLIS, but because of our pipeline of products. We have demonstrated that we can move a product through the regulatory hurdles even under the most challenging of financial and regulatory circumstances, and this should leave investors with confidence that we can replicate this process with our pipeline of products.”