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BioDelivery Sciences Confirms Dose Proportionality with BEMA(TM) Fentanyl

24 Apr 2006

Today announced the results of a pharmacokinetic study with BEMA(TM) Fentanyl. The study demonstrated that both peak plasma fentanyl concentrations and overall exposure increase in a linear manner (i.e., in proportion to the dosage amount) across the range of BEMA(TM) Fentanyl doses tested.

MORRISVILLE, NC, USA | Apr 24, 2006 | BioDelivery Sciences International, Inc. (NASDAQ: BDSI), a specialty biopharmaceutical

company, announced the results of a pharmacokinetic study with BEMA(TM) Fentanyl. The study demonstrated that both peak plasma fentanyl concentrations and overall exposure increase in a linear manner (i.e., in proportion to the dosage amount) across the range of BEMA(TM) Fentanyl doses tested. This result is known as dose proportionality, meaning that a change in the dose results in a proportional change in the maximum circulating concentration of the subject pharmaceutical. Achieving dose proportionality is a key milestone in the clinical testing of a pharmaceutical product.

This study was performed in healthy subjects (not patients) to evaluate the relationship between the dose of fentanyl administered and the plasma concentrations achieved. Plasma fentanyl concentrations are related to the pharmacologic effects of the product and normal volunteers are typically used for these studies. Participating subjects received each of 3 different doses of BEMA(TM) Fentanyl.

Dr. Andrew Finn, BDSI's Executive Vice President of Clinical Development and Regulatory Affairs, said "The results demonstrated that mucosal absorption of fentanyl can be rapid and predictable, without the need for patient effort in the application process. We believe that this ease of administration will distinguish BEMA(TM) Fentanyl as a product for the management of breakthrough cancer pain."

Dr. Mark Sirgo, BDSI's President and Chief Executive Officer, added "While this study was a necessary component of our BEMA(TM) Fentanyl development program for the treatment of breakthrough cancer pain, we believe that the results serve as an important demonstration of the robustness of our patented BEMA(TM) delivery system and its ability to accommodate several different strengths of fentanyl in a dose proportionate fashion. These same dosage strengths are part of our BEMA(TM) Fentanyl Phase III program, which we anticipate completing by the end of 2006. These study results add to the body of evidence we are collecting on BEMA(TM) Fentanyl that support our confidence in the commercial viability of this product in the marketplace."

Within the global market, pain medication generates estimated annual sales of more than $24 billion. An estimated $2 to $4 billion is targeted at breakthrough pain, with BEMA(TM) Fentanyl's indication of breakthrough cancer pain being a subset of this market. BDSI believes that BEMA(TM) Fentanyl maintains a strong potential of securing a significant share of the breakthrough cancer pain market in the U.S. The company estimates that BEMA(TM) Fentanyl will generate minimum annual peak sales of $250 million.

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: BioDelivery Sciences International, Inc

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