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BioDelivery Sciences Files IND for BEMA(TM) LA, a Treatment for Moderate to Severe Pain

Posted on: Friday, 6 January 2006, 09:00 CST

BioDelivery Sciences International, Inc. (NASDAQ:BDSI) announced today that it has submitted an initial Investigational New Drug (IND) Application with the U.S. Food and Drug Administration (FDA) for the company's BEMA(TM) Long Acting Analgesic (LA) product. If and when approved by FDA, BEMA(TM) LA is intended to meet the need for an alternative route of administration of an existing, marketed narcotic for the treatment of moderate to severe pain. BEMA(TM) LA will be formulated using BDSI's licensed BEMA(TM) technology platform, which consists of a fast dissolving mucoadhesive disc designed to rapidly deliver the active ingredient across the buccal mucosa of the mouth.

BDSI believes that BEMA LA represents a substantial opportunity to capture market share in a pain market that generated reported 2004 sales of $21 billion and is estimated to grow to $29.8 billion by 2008. Due to the potential for BEMA(TM) LA to be used to treat a variety of pain conditions, BDSI believes that the product could capture a 1-2% share of the total worldwide pain market and potentially generate peak sales of between $250 million and $500 million.

BEMA(TM) LA will be a formulation of an analgesic which is already FDA-approved, which is substantially more potent than morphine, but which BDSI believes has a lower risk of serious adverse reactions and abuse.

As previously announced, BEMA(TM) LA was the subject of a pre-IND meeting with the FDA in November of 2005 and will be developed in adherence to BDSI's business model of 505(b)(2) NDA submissions. Accordingly, the first human clinical trial will be a pharmacokinetic comparison in normal volunteers with the current formulations of the active ingredient in the reference listed drugs already approved and on the market.

Dr. Andrew Finn, Executive Vice President of Clinical and Regulatory Development for BDSI, stated, "We expect that the results of this initial human study for BEMA(TM) LA will provide additional data supporting the robust performance of the BEMA(TM) delivery technology as well as an alternative delivery of the active ingredient that will potentially benefit patients."

Dr. Mark Sirgo, President and CEO of BDSI, stated, "The filing of this IND further demonstrates the commitment of BDSI to develop a broad portfolio of products in our areas of interest and is additional evidence of BDSI's ability to execute our announced development plans. This longer acting pain product will complement our first product formulated with the BEMA(TM) technology, BEMA(TM) Fentanyl, which will be used specifically for the treatment of breakthrough cancer pain. BEMA(TM) LA will initially target moderate to severe pain. Needless to say, with our existing NDA for Emezine(R) (prochlorperazine maleate) under review at FDA; BEMA(TM) Fentanyl entering Phase III and now with our ability to move forward with BEMA(TM) LA into human testing, 2006 has the potential to be an extremely exciting year for BDSI."

BDSI's patented BEMA(TM) drug delivery system is exclusively licensed to BDSI on a worldwide basis. The BEMA(TM) delivery technology consists of an easy to use, dissolvable, dime-sized polymer disc that is applied to the mucus membrane (between the cheek and gum) of the mouth. The disc dissolves over approximately 20-30 minutes, delivering the drug across the mucus membrane for rapid absorption and onset of effect.

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 Bioral(R) nanocochleate technology, designed for a potentially broad base of applications, and (ii) the patented BEMA(TM) (transmucosal or mouth) drug delivery technology. 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, the results of 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).

Source: Business Wire

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