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BDSI announces positive phase III clinical trial results

oval by FDA and that our development and commercialization activities continue as planned, we continue to believe that we will ultimately reach our annual peak sales projection of $250 million for the treatment of breakthrough cancer pain."

"On behalf of the Board of Directors, I want to congratulate our senior management and our entire BEMA Fentanyl team for achieving this pivotal milestone in the history of BDSI" said Frank E. ODonnell Jr., M.D., Chairman of the Board of BDSI. "Since the addition of Drs. Sirgo and Finn to our senior management team in 2004, BDSI has made great strides in its evolution from a drug delivery company into a specialty pharmaceutical company. In that time, under their dedicated, tireless and very able leadership, BDSI has carefully marshaled and focused its resources, faced and overcome many obstacles and stayed true to its pursuit of the capital and time efficient 505(b)(2) regulatory pathway. Our team has brought tangible value to our stockholders, and our board takes this time to state its appreciation and admiration of the efforts of our management team and all of our employees."

Dr. ODonnell continued, "We are hopeful that this demonstration of the effectiveness of BEMA Fentanyl augers very well for the potential application of the BEMA technology to other therapeutics that normally require parenteral administration. While it is true that work remains to be completed in the regulatory and commercial areas for BEMA Fentanyl, now that we have demonstrated the clinical value of this important delivery technology, we will seek to expand our pipeline of other clinically and economically valuable applications and partnerships."

Patients from the efficacy study were also eligible for entry in the long-term safety study with BEMA Fentanyl, which is still ongoing. The two studies together will form the foundation of BDSIs New Drug Application (NDA) scheduled for submission during the third quarter of 2007.
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Contact: Bill Douglass
bdouglass@investorrelationsgroup.com
212-825-3210
BioDelivery Sciences
25-Apr-2007


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