BDSI Announces Submission of NDA for Emezine; First Transmucosal Product for the Treatment of Nausea and Vomiting

BioDelivery Sciences International, Inc. (NASDAQ:BDSI)
(NASDAQ:BDSIW), announced today that it has submitted a new drug
application (NDA) to the U.S. Food and Drug Administration for
Emezine(R), 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. In
February 2005, BDSI announced that it had completed the clinical
studies required for an NDA on Emezine(R).
   Dr. Andrew L. Finn, BDSI's Executive Vice President of Clinical
Development and Regulatory Affairs, said "We believe that Emezine(R)
is a product that will address a growing and presently unserved need
in the marketplace, and we are very hopeful that the FDA will find our
submission acceptable for filing. We believe we have adhered to the
requirements we agreed upon with the FDA at our pre-NDA meeting last
year. We are also very pleased with the tremendous team effort behind
our Emezine(R) project, including the assistance of Reckitt Benckiser,
from whom we license Emezine(R), and great planning and execution by
our own BDSI staff. We are proud that this effort allowed us to move
from the finalization of our development plan to a NDA submission in
12 months."
   Dr. Mark A. Sirgo, BDSI's President and COO, said "This is a major
achievement for our company. It validates our business model of
applying the FDA's streamlined 505(b)(2) approval process to move
proven therapeutics, which are then combined with delivery
technologies, through the development pipeline. In addition, the
filing of this NDA, which is the first for BDSI, is a testament to our
ability as an organization to follow through on our announced plans.
Dr. Finn did an extraordinary job in executing the development plan
for Emezine(R) and meeting the corporate timeline for this significant
FDA submission. With this submission behind us, we will now
concentrate efforts on moving our next product, BEMA(TM) Fentanyl,
into Phase III clinical trials for the treatment of breakthrough
cancer pain this year."
   BioDelivery Sciences International, Inc. is a specialty
biopharmaceutical company that is exploiting its licensed and patented
drug delivery technologies to develop and commercialize, or partner
with third parties on, clinically-significant new formulations of
proven therapeutics, nutraceuticals and micronutrients. 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 being developed by the company's Arius
Pharmaceuticals subsidiary. Arius is developing products for the
"acute" treatment opportunities such as pain, anxiety, nausea and
vomiting, and infections. The company's headquarters are located in
Morrisville, North Carolina and its principal laboratory is located in
Newark, New Jersey.
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press release contains, among other things, certain forward-looking
statements, within the meaning of the Private Securities Litigation
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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,
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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).
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