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BioDelivery Sciences Updates Product Development Pipeline Status and 2006 Milestones

Posted on: Tuesday, 14 March 2006, 09:01 CST

BioDelivery Sciences International, Inc. (NASDAQ:BDSI):

Company Has over $1 Billion in Estimated Peak Revenue Potential for Products under Development; Pain Franchise Products Noted as Key Value

Driver for Company

BioDelivery Sciences International, Inc. (NASDAQ:BDSI), a specialty biopharmaceutical company, provided the following update on the portfolio of products in its development pipeline and the company's 2006 milestones: Product Development Pipeline Product Indication Clinical Status Peak Sales* ------- ---------- --------------- ------------ BEMA(TM) Breakthrough Cancer Phase III Clinical $250 million Fentanyl Pain Trials BEMA(TM) LA Moderate-Severe Pain IND filed, Phase I: $500 million 2Q 2006 Bioral(R) Fungal Infections Formulation / Pre- $400 million Amphotericin B Clinical: Phase I: 3Q 2006 BEMA(TM) Anxiety / Insomnia Pre-Formulation $250 million Zolpidem Emezine(R) Nausea / Vomiting Status of NDA under $30 million discussion with FDA** * BDSI estimates, assuming FDA approval. BDSI to pay royalties to licensors and partners. ** BDSI preparing response for meeting with FDA based on recent NDA decision. 2006 Milestones Product Milestone Quarter ------- --------- ------- BEMA(TM) Fentanyl Report Phase III Data Q4 BEMA(TM) LA Report Phase I Data Q2 Report Phase II Data Q4 Intention to Proceed into Phase III Q4 Bioral(R) Amphotericin B File IND Q2-3 Report Phase I Data Q3 Intention to Proceed into Phase II Q3-4 BEMA(TM) Zolpidem File IND Q4 Emezine(R) FDA meeting to address open items Q2

Dr. Mark A. Sirgo, President and CEO of BDSI, stated, "We have a diversified portfolio of proposed formulations and products in various stages of development that have an estimated combined peak revenue potential of greater than $1 billion per year. Our most significant near term asset, BEMA(TM) Fentanyl, has, we believe, peak sales potential of $250 million dollars and is currently moving through Phase 3. BEMA(TM) Fentanyl will be the first of our two lead pain franchise products which we expect to participate in the large and growing pain therapy area."

As it relates to BDSI's 2006 milestones, Dr. Sirgo continued, "We are encouraged by our progress and we are determined to achieve a number of significant milestones in the next three quarters, in particular our pain franchise of BEMA(TM) Fentanyl and BEMA(TM) LA, which we believe have the potential to significantly drive stockholder value in BDSI this year."

About BioDelivery Sciences International

BioDelivery Sciences International, Inc. is a specialty biopharmaceutical company that is exploiting its licensed and patented drug delivery technologies to develop and commercialize, either on its own or in partnerships with third parties, clinically-significant new formulations of proven therapeutics targeted at "acute" treatment opportunities such as pain, anxiety, nausea and vomiting, and infections. The company's drug delivery technologies include: (i) the patented BEMA(TM) (transmucosal or mouth) drug delivery technology and (ii) the patented Bioral(R) nanocochleate technology, designed for a potentially broad base of applications. 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.

Forward-Looking Statements

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, 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). Peak sales 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.

Source: Business Wire

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