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BDSI files FDA NDA for BEMA Fentanyl
Date:10/31/2007

MORRISVILLE, N.C.--(BUSINESS WIRE)--BioDelivery Sciences International, Inc. (Nasdaq: BDSI, http://www.biodeliverysciences.com) has submitted its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for BEMATM Fentanyl, BDSIs treatment for patients with breakthrough cancer pain.

The filing of the NDA represents a progression in a series of recent milestones relating to BDSIs lead product, including the April 2007 announcement that BEMA Fentanyl met the primary efficacy endpoint in its placebo controlled study for breakthrough cancer pain and the recent announcement of a U.S. commercialization partnership with Meda AB.

The FDA will now have sixty days in which to consider the NDA for filing. If accepted for filing, the FDA will have an additional eight months to complete the review of the application; as a result, BDSI expects a final decision by FDA in August 2008. If approved, BDSI is expected to receive milestone payments from Meda totaling $30 million and could begin receiving royalty revenues from the product as early as fourth quarter of 2008. BEMA Fentanyl has minimum peak sales projections of $250 million in the U.S. according to BDSI projections.

Our team has been very diligent in following the FDAs guidance on the development of BEMA Fentanyl and the preparation of the NDA, said Dr. David Wright, Director of Regulatory Affairs at BDSI. Given the nature of our pre-submission communications with the FDA, we anticipate a very interactive review process over the next ten months.

As previously announced, the efficacy results from the pivotal Phase III efficacy trial demonstrated that patients treated with BEMA Fentanyl in doses from 200 mcg to 1200 mcg had a significantly greater reduction in pain than patients treated with placebo, with less than 4% of patients discontinuing because of lack of effectiveness. A similar low discontinuation rate (< 3.5%) for lack of e
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Contact: Bill Douglass
bdouglass@investorrelationsgroup.com
212-825-3210
BioDelivery Sciences
Source:Eurekalert

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