BDSIW Biodelivery Sciences International (MM)

BioDelivery Sciences International, Inc. (NASDAQ:BDSI) (NASDAQ:BDSIW) announced today that it has received written notification from the U.S. Food and Drug Administration that its new drug application (NDA) for Emezine(R) has been accepted for review. BDSI previously announced that it filed such NDA in late April 2005, and this written notification indicates that FDA review of the product is now underway. Under FDA regulations, the FDA has up to 10 months from the date of NDA submission to review and render a decision on the application as to whether it is approvable or not. Emezine(R) is a formulation of prochlorperazine, a currently approved agent for the treatment of nausea and vomiting. Emezine(R) is conveniently administered by placing the dissolving tablet between the upper lip and gum, thereby delivering the drug across the membrane of the mouth. To the best of BDSI's knowledge, Emezine(R), if approved by the FDA, would be the first and only transmucosal medication for nausea and vomiting in the United States. BDSI believes that Emezine(R) will give physicians a patient-friendly alternative to injections or suppositories for the treatment of nausea and vomiting associated with a wide range of conditions such as surgery, chemotherapy and migraine attacks. BDSI has the exclusive U.S. rights to Emezine(R) under a license agreement with Reckitt Benckiser Healthcare (UK) Limited. The FDA's review of Emezine(R) is being undertaken through the FDA's 505(b)(2) approval process. Under this process, a company is able to seek FDA approval of a new dosage form, dosage regimen or new indication of a pharmaceutical that has previously been approved by the FDA. This regulation enables a company to partially rely on the findings of third parties which the FDA has published on approved pharmaceuticals, including clinical and non-clinical testing, thereby reducing, though not eliminating, the need to engage in these costly and time consuming activities. Dr. Mark A. Sirgo, BDSI's President and COO, said: "We are very gratified that the review process for Emezine(R) is underway and we look forward to working with the FDA on this project. We are equally gratified that we have been able to continue the execution of our publicly-announced plans. As we move into the second half of 2005, we hope to continue this trend with our entry into our Phase III program with BEMA(TM) Fentanyl and the filing our IND and first human trial for Bioral(R) Amphotercin B." 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. 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 (including, without limitation, its initiation of clinical trials and the FDA approval process), 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 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). L.G. Zangani, LLC provides financial public relations service to the Company. As such L.G. Zangani, LLC and/or its officers, agents and employees, receives remuneration for public relations and or other services in the form of monies, capital stock in the Company, warrants or options to purchase capital in the Company.