PipelineReview.com - Biotech News & Online Store - BioDelivery Sciences Demonstrates Multiple Dose Linearity with BEMA(TM) Fentanyl; Another Development Milestone is Achieved in BDSI's Phase III BEMA(TM) Fentanyl Program

BioDelivery Sciences Demonstrates Multiple Dose Linearity with BEMA(TM) Fentanyl; Another Development Milestone is Achieved in BDSI's Phase III BEMA(TM) Fentanyl Program

23 May 2006

MORRISVILLE, NC, USA | May 22, 2006 | BioDelivery Sciences International, Inc. (NASDAQ:BDSI), a specialty biopharmaceutical

company, announced the results of a multiple dose pharmacokinetic study regarding the company's flagship BEMA(TM) Fentanyl product. The study demonstrated that mean plasma fentanyl concentrations are highly reproducible and show a linear increase with multiple doses, reflecting a very predictable dosage form.

The BEMA(TM) drug delivery disc is a small, dissolvable polymer disc applied to the buccal (inner lining of cheek) membranes of the mouth. In the study announced today, an open-label, multiple dose, three-period study was performed in healthy volunteers who received a single 600 microg dose of BEMA(TM) fentanyl buccal disc in period 1, followed by another 600 microg dose in period 2, and three sequential 600 microg doses separated by an hour in period 3. The study demonstrates that administration of a second and third dose (1800 microg over a two-hour period) results in a linear increase in plasma concentrations over the initial dose. Further, each of the single 600 microg doses yielded 1 ng/mL reproducibly in all subjects, meaning plasma concentrations were very similar from patient to patient. BEMA(TM) Fentanyl is being targeted for the indication of "breakthrough" cancer pain (i.e., episodes of severe pain which "break through" the medication used to control the persistent pain).

Dr. Andrew Finn, BDSI's Executive Vice President of Clinical Development and Regulatory Affairs, said "The results from this recent study suggest that we should expect consistent delivery of fentanyl from our patented BEMA(TM) formulation from dose to dose and if multiple doses are needed, the plasma fentanyl concentrations will increase predictably with dose. We believe that these factors will fulfill an important need in treating the varying severity associated with breakthrough cancer pain and offer significant differences compared with competing products currently under development that appear to have non-linear pharmacokinetics. We are quite pleased with these results and are gratified to have been able to achieve another milestone in our clinical development for BEMA(TM) Fentanyl."

"This multi-dose data goes hand in hand with the single dose proportionality study data we reported several weeks ago," stated BDSI's President and CEO Dr. Mark Sirgo. "We now have confirming evidence in two studies that should afford clinicians assurance that BEMA(TM) Fentanyl provides reliable increases in plasma concentration with dose. We continue to be extremely optimistic about the commercial viability of our product compared to other products in development."

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. BDSI estimates that BEMA(TM) Fentanyl will generate minimum annual peak sales of $250 million. The BEMA(TM) Fentanyl Phase III program, which is currently ongoing, is expected to be completed by the end of 2006.

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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