BioDelivery Sciences Claims Recent Actions by Clinical Development Capital Undermine All Other Stockholders' Interests.

MORRISVILLE, N.C. -- Company Claims its Partner Has Breached BEMA(TM) Fentanyl Development Agreement and is Attempting to Seize BDSI's Phase III Product for Itself

BioDelivery Sciences International, Inc. (NASDAQ:BDSI) has notified CDC IV, LLC (CDC), an affiliate of Clinical Development Capital and Care Capital of Princeton, New Jersey and a partner on BDSI's Phase III BEMA(TM) Fentanyl, of its claim that CDC has breached the July 2005 Clinical Development and License Agreement between BDSI and CDC (the "CDLA") by repeatedly and willfully refusing to: (1) convene or designate its representatives to the Development Committee required under the CDLA, despite BDSI's numerous requests to do so and (2) respond to repeated requests from BDSI for collaboration with BDSI management on the BEMA(TM) Fentanyl program as provided for under the CDLA. BDSI further claims that CDC has willfully refused (despite BDSI's requests) to comply with the requirements of the negotiated dispute resolution provisions clearly outlined in the CDLA.

In addition to the breach by CDC of its obligations under the CDLA, BDSI has learned that CDC, for its own benefit, after it became a stockholder in May 2006 and without BDSI's knowledge or consent, attempted to purchase the patents and/or rights underlying the BEMA(TM) technology directly from BDSI's licensor. CDC made this attempt while in possession of confidential information regarding the BEMA(TM) Fentanyl program and knowing that ownership and control of the BEMA(TM) patents had been a long term corporate objective of BDSI.

Also, in August 2006, CDC offered BDSI what CDC is terming a financing, but was actually a proposal to purchase from BDSI an additional royalty on the BEMA(TM) Fentanyl product on terms that were significantly less beneficial to BDSI than those in the July 2005 and May 2006 agreements. For example, under the CDC proposal, the royalty rate to CDC would be tripled, BDSI would be required to pay CDC 100% of the purchase price back upon regulatory approval of BEMA(TM) Fentanyl anywhere in the world, and there was a requirement to pay CDC a minimum royalty of 90% of the purchase price annually after the first year. Moreover, the proposed royalty purchase would do nothing to augment BDSI's stockholder equity. BDSI's board of directors has rejected the CDC proposal. This proposal, coupled with CDC's effort to acquire the BEMA(TM) technology from the licensor, if it had occurred, would have produced a financial windfall to CDC at the expense of all other BDSI stockholders.

Although CDC claims that they are acting in the best interest of all BDSI stockholders, BDSI believes otherwise. CDC, unlike any other BDSI stockholder, has a royalty interest in a particular product, BEMA(TM) Fentanyl. BDSI believes it is clear from CDC's actions relating to, among other things, its breaches of the CDLA and its unfavorable royalty purchase offer to BDSI in August, that CDC is acting in its own self-interests.

"Simply put, CDC is upset because it wanted more of our flagship BEMA Fentanyl product and we refused their proposal. Our message to our stockholders at this time is two-fold: first, we at BDSI will continue to seek to progress our promising product pipeline, including the completion of our Phase III program with BEMA(TM) Fentanyl, despite this distraction, and second, our stockholders should in no way view CDC's actions to be motivated by the best interests of all BDSI stockholders. Rather, this is a self-serving attempt to gain more financial control over this particular corporate asset."

In its notice of breach to CDC, BDSI reserved the right to make additional claims against CDC and demanded that all claims under the CDLA be submitted immediately for resolution pursuant to the dispute resolution mechanisms set forth in the CDLA.

More detail on this matter can be found in BDSI's Current Reports on Form 8-K filed with the SEC on August 31, 2006.

About BioDelivery Sciences International

BioDelivery Sciences International, Inc. is a specialty pharmaceutical company that is focused on developing innovative products to treat acute conditions such as pain. The company utilizes its owned and licensed patented drug delivery technologies to develop 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 treatment for "breakthrough" cancer pain which is expected to complete its Phase III BEMA Fentanyl trials during the second half of 2006, and BEMA(TM) LA, a second analgesic with a target indication of the treatment of moderate to severe pain, which is currently in Phase I trials and on which the company intends to initiate Phase III trials in the second half of 2006. The company is also working with both its BEMA(TM) technology and its patented Bioral(R) nanocochleate technology on products targeted at other acute treatment opportunities such as insomnia, nausea and vomiting, and infections. The company's headquarters are located in Morrisville, North Carolina and its principal laboratory is located in Newark, New Jersey. For more information please visit www.bdsinternational.com.

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Note: Except for the historical information contained herein, this press release contains, among other things, certain forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995, that involve risks and uncertainties. Such statement may include, without limitation, statements with respect to the Company's plans, objectives, expectations and intentions and other statements identified by words such as "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, the outcome of contractual and other disputes, actual sales results, if any, or the results of scheduled or additional clinical trials and FDA review of the Company's formulations and products, may differ 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).