BioDelivery Sciences International, Inc. (Nasdaq: BDSI) today announced
that four scientific posters for its lead product, BEMA™
Fentanyl, currently under review by the U.S. Food and Drug
Administration (FDA) as a potential treatment for breakthrough pain
(BTP) in opioid-tolerant patients with cancer, will be presented at the
27th Annual Scientific Meeting of the American Pain Society (APS), May 8–10,
in Tampa, Florida. The scientific presentations will highlight the Phase
III efficacy and safety data as well as the pharmacokinetics of BEMA™
Fentanyl. The posters will be presented on May 8 and 9.
In January, BioDelivery Sciences announced that the FDA accepted for
filing the company’s New Drug Application
(NDA) for BEMA™ Fentanyl. BioDelivery Sciences
anticipates a formal decision on the NDA by August 31, 2008. In North
America and Europe, the commercial rights to BEMA™
Fentanyl are licensed to Meda AB.
Posters displayed on Thursday, May 8, from 4:45 p.m. to 6:15 p.m. EDT:
“Rapid and Effective Control of Breakthrough
Pain and Tolerability in Cancer Patients Treated with BEMA™
Fentanyl,” James North, MD, Principal
Investigator for the Phase III efficacy study
“Dose Linearity and Absolute
Bioavailability of BEMA™ Fentanyl in
Healthy Volunteers,” Niraj Vasisht, Vice
President, Product Development, BioDelivery Sciences
Posters displayed on Friday, May 9, from 4:00 p.m. to 5:30 p.m. EDT:
“The Safety of BEMA™
Fentanyl Use for Breakthrough Pain in Cancer Patients,”
Neal F. Slatkin, Medical Director, Department of Supportive Care, Pain
and Palliative Medicine, City of Hope National Medical Center
“Adverse Events Affecting the Mouth in
Three Clinical Trials of BEMA™ Fentanyl,”
David Blum, MD, Vice President, Medical Affairs and Clinical Research,
BioDelivery Sciences
BioDelivery Sciences invites members from the media and scientific
community to schedule private meetings with company experts and the
principal investigator of the Phase III efficacy study in advance by
contacting Stephanie Brown at stephanie.brown@fdashtonpartners.com.
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 conditions such as pain. The
company utilizes its owned and licensed patented drug delivery
technologies to develop, partner, and commercialize new products using
proven therapeutics. BDSI’s pain franchise
currently consists of two products in development utilizing the company’s
patented BEMA™ oral adhesive film technology:
BEMA™ Fentanyl, a potential treatment for “breakthrough”
pain in opioid tolerant patients with cancer (NDA currently under review
by FDA), and BEMA™ Buprenorphine, a second
analgesic with at least one potential target indication for the
treatment of moderate to severe pain. The company is working with both
its BEMA™ technology and its patented Bioral®
cochleate technology on products targeted at conditions common to
oncology and surgical patients such as pain and 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 (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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