BioDelivery Sciences International, Inc. (Nasdaq:BDSI) in compliance
with Nasdaq Marketplace Rule 4350(b)(1)(B), which requires separate
disclosure of receipt of an audit opinion that contains a going concern
qualification, disclosed that its previously filed Annual Report on Form
10-K for the fiscal year ended December 31, 2007, as amended, contains a
going concern qualification from its independent registered public
accounting firm, Aidman, Piser & Company, P.A.
This announcement does not represent any change or amendment to the
BioDelivery Sciences’ fiscal 2007 financial
statements or to its Annual Report on Form 10-K filed with the SEC on
March 7, 2008. BioDelivery Sciences’ Annual
Report on Form 10-K, as amended, is available from the SEC’s
website at www.sec.gov.
BioDelivery Sciences had cash and cash equivalents and a certificate of
deposit of approximately $16.6 million at December 31, 2007. As
previously disclosed, in December 2007 the U.S. Food and Drug
Administration (FDA) accepted for filing BioDelivery Sciences’
New Drug Application (NDA) for BEMATM Fentanyl,
and the company has been informed by FDA that the PDUFA date (i.e., the
date on which a decision by FDA on the BEMATM
Fentanyl is expected) is August 31, 2008. BioDelivery Sciences is
expected to receive milestone payments aggregating $30.0 million from
its commercial partner Meda AB in connection with FDA approval and
commercial launch of BEMA™ Fentanyl. The
company received a non-refundable up-front milestone payment of $30.0
million from Meda in September 2007.
About BioDelivery Sciences International
BioDelivery Sciences International, Inc. is a specialty pharmaceutical
company that is focused on developing innovative products to address
growing market opportunities, including pain. The company utilizes its
owned and licensed patented drug delivery technologies to develop,
partner, and commercialize clinically-significant new products using
proven therapeutics. BDSI’s pain franchise
currently consists of two products in development utilizing the company’s
patented BEMA™ oral adhesive disc technology:
BEMA™ Fentanyl, a potential treatment for “breakthrough”
cancer pain with its NDA under review by FDA, and BEMA™
Buprenorphine, a second analgesic with a target indication of the
treatment of moderate to severe pain. The company is also working with
both its BEMA™ technology and its patented
Bioral® cochleate
technology on products targeted at other acute treatment opportunities
such as infections. The company’s
headquarters are located in Raleigh, 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 and the statements of representatives and partners of
BioDelivery Sciences International, Inc. (the “Company”)
related thereto contain or may contain, among other things, certain
forward-looking statements, within the meaning of the Private Securities
Litigation Reform Act of 1995. Such forward-looking statements involve
significant risks and uncertainties. Such statements may include,
without limitation, statements with respect to the Company’s
plans, objectives, projections, expectations and intentions and other
statements identified by words such as “projects”,
“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: (i) actual sales results and royalty or
milestone payments, if any, (ii) the application and availability of
corporate funds and the Company’s need for
future funds or the Company’s ability to
continue as a going concern, or (iii) the timing for completion, and
results of, scheduled or additional clinical trials and the FDA’s
or other regulatory review and/or approval and commercial launch of the
Company’s formulations and products and
regulatory filings related to the same, may differ significantly 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 and market size 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.
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