BioDelivery Sciences Receives $2.5 Million and Announces Marketing Partner Meda AB has Filed for European Approval of BEMA(TM) Fentanyl.

$2.5 million milestone payment received by BioDelivery Sciences as part of European Meda Agreement

RALEIGH, N.C. -- BioDelivery Sciences International, Inc. (Nasdaq: BDSI) announced that Meda AB, its commercialization partner for BEMA[TM] Fentanyl in North America and Europe, has submitted a dossier seeking approval to market BEMA[TM] Fentanyl for the treatment of breakthrough pain in opioid tolerant cancer patients to the German Federal Institute for Drugs and Medical Devices (BfArm). Meda has chosen to utilize the Decentralized Procedure to obtain marketing approval throughout the European Union with Germany serving as the reference member country.

BioDelivery Sciences received a $2.5 million milestone payment for completion of the clinical trial work supporting the dossier and expects to receive an additional milestone payment on approval, followed by revenues from a double digit royalty on net sales.

"This submission clearly reflects the priority Meda has placed on gaining approval for BEMA[TM] Fentanyl both in Europe and in the U.S.," said Dr. Mark A. Sirgo, President and Chief Executive Officer of BioDelivery Sciences. "It also reflects our opinion there is a clear market opportunity for BEMA[TM] Fentanyl and underscores our unwavering focus toward providing a new treatment option for cancer patients experiencing breakthrough pain."

"Breakthrough pain is a common condition in cancer patients, so it is important to continue developing improved therapies in this area," stated Anders Lonner, Chief Executive Officer of Meda AB. "We are pleased with BioDelivery Sciences' progress and are eager to introduce BEMA[TM] Fentanyl for breakthrough cancer pain to the European market where current treatment modalities continue to prove suboptimal."

As previously disclosed, the U.S. Food and Drug Administration (FDA) accepted for filing BioDelivery Sciences' New Drug Application (NDA) for BEMA[TM] Fentanyl. BioDelivery Sciences is expecting a response from FDA on the BEMA[TM] Fentanyl NDA by August 31, 2008. In September 2007, BioDelivery Sciences announced a licensing agreement with Meda AB for the distribution rights in the U.S., Canada, and Mexico for BEMA[TM] Fentanyl. In August 2006, Meda AB secured from BioDelivery Sciences the rights to distribute BEMA[TM] Fentanyl in Europe.

Breakthrough cancer pain is characterized by the episodes of severe pain that "break through" the base opioid medications used to control persistent pain. The worldwide market for breakthrough cancer pain is expected to reach $2.5 billion by 2016 according to Datamonitor. In addition, a recent European Pain in Cancer (EPIC) survey revealed that 63 percent of cancer patients report they are affected by breakthrough pain. The study disclosed that only one-third of these patients take additional medications to treat their breakthrough pain, and merely 35 percent of patients taking additional medications report the medicine is effective.

About BEMA[TM] Fentanyl

BDSI's lead product under development is BEMA[TM] Fentanyl, a potential treatment for "breakthrough" pain (i.e., episodes of severe pain which "break through" the medication used to control the persistent pain). BEMA[TM] Fentanyl consists of a small, dissolvable, polymer disc, formulated with the opioid narcotic fentanyl for application to the buccal (inner lining of cheek) membranes. Fentanyl belongs to the group of medicines called narcotic analgesics, which are used to relieve pain. The BEMA[TM] delivery technology is particularly well suited for the delivery of products where rapid onset of activity and convenient administration are important. BDSI believes there is a clear need and growing market for additional narcotic agents in alternative dosage forms to provide rapid and convenient pain relief.

About BioDelivery Sciences International

BioDelivery Sciences International, Inc. is a specialty pharmaceutical company that is focused on developing innovative products to address growing market opportunities, including acute conditions such as pain. The company utilizes its owned and licensed patented drug delivery technologies to develop, partner, and commercialize clinically-significant new products using proven therapeutics. BDSI's pain franchise currently consists of two products in development utilizing the company's patented BEMA[TM] oral adhesive disc technology: BEMA[TM] Fentanyl, a potential treatment for "breakthrough" pain with its NDA under review by FDA, and BEMA[TM] Buprenorphine, a second analgesic with a target indication of the treatment of moderate to severe pain. The company is also working with both its BEMA[TM] technology and its patented Bioral([R]) cochleate technology on products targeted at other acute treatment opportunities such as infections. The company's headquarters are located in Raleigh, North Carolina and its principal laboratory is located in Newark, New Jersey. For more information please visit www.bdsinternational.com.

Forward-Looking Statements

Note: Except for the historical information contained herein, this press release and the statements of representatives and partners of BioDelivery Sciences International, Inc. (the "Company") related thereto contain or may contain, among other things, certain forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve significant risks and uncertainties. Such statements may include, without limitation, statements with respect to the Company's plans, objectives, projections, expectations and intentions and other statements identified by words such as "projects", "may", "could", "would", "should", "believes", "expects", "anticipates", "estimates", "intends", "plans" or similar expressions. These statements are based upon the current beliefs and expectations of the Company's management and are subject to significant risks and uncertainties, including those detailed in the Company's filings with the Securities and Exchange Commission. Actual results, including, without limitation: (i) actual sales results and royalty or milestone payments, if any, (ii) the application and availability of corporate funds and the Company's need for future funds, or (iii) the timing for completion, and results of, scheduled or additional clinical trials and the FDA's or other regulatory review and/or approval and commercial launch of the Company's formulations and products and regulatory filings related to the same, may differ significantly from those set forth in the forward-looking statements. These forward-looking statements involve certain risks and uncertainties that are subject to change based on various factors (many of which are beyond the Company's control). Peak sales and market size estimates have been determined on the basis of market research and comparable product analysis, but no assurances can be given that such sales levels will be achieved, if at all.