BioDelivery Sciences to Present at the Cowen and Company 34th Annual Health
RALEIGH, N.C., Feb. 28, 2014
RALEIGH, N.C., Feb. 28, 2014 /PRNewswire/ -- BioDelivery Sciences
International, Inc. (Nasdaq: BDSI) announced that Dr. Mark A. Sirgo, President
and Chief Executive Officer of BDSI, will present at the Cowen and Company
34^th Annual Health Care Conference. The presentation is scheduled for
Tuesday, March 4, 2014 at 8:40 a.m. Eastern Time at the Boston Marriott Copley
BDSI submitted a New Drug Application (NDA) for BUNAVAIL for the treatment of
opioid dependence, and based on timelines established by the Prescription Drug
User Fee Act (PDUFA), the review of the BUNAVAIL NDA is expected to be
completed by June 7, 2014. Dr. Sirgo will be providing an update on BUNAVAIL
commercial options and the anticipated market opportunity.
Additionally, Dr. Sirgo will provide an update on the progress made by BDSI
and its commercial partner, Endo Pharmaceuticals, with the ongoing Phase 3
clinical program for BEMA Buprenorphine for the treatment of chronic pain,
including the recently announced positive topline results from the Phase 3
clinical study in opioid naïve patients.
The presentation will be webcast live and can be accessed at www.bdsi.com.
For those who are not available to listen to the live broadcast, a replay of
the webcast will be available on the BDSI website.
About BioDelivery Sciences International
BioDelivery Sciences International (NASDAQ: BDSI) is a specialty
pharmaceutical company that is leveraging its novel and proprietary patented
drug delivery technologies to develop and commercialize, either on its own or
in partnerships with third parties, new applications of proven therapeutics.
BDSI is focusing on developing products to meet unmet patient needs in the
areas of pain management and addiction.
BDSI's pain franchise currently consists of three products. ONSOLIS^®
(fentanyl buccal soluble film) is approved in the U.S.,Canada, and the E.U.
(where it is marketed as BREAKYL^TM), for the management of breakthrough pain
in opioid tolerant, adult patients with cancer. The commercial rights are
licensed to Meda for all territories worldwide except forTaiwan(licensed to
TTY Biopharm) andSouth Korea (licensed to Kunwha Pharmaceutical Co.). BEMA
Buprenorphine, which is licensed on a worldwide basis to Endo Pharmaceuticals,
is currently in Phase III development for the treatment of moderate to severe
chronic pain. Clonidine Topical Gel is expected to enter Phase III trials in
the first quarter of 2014 for the treatment of painful diabetic neuropathy.
BUNAVAIL^TM, a BEMA formulation of buprenorphine and naloxone, is currently
under review by FDA for the maintenance treatment of opioid dependence and has
a PDUFA date of June 7, 2104.
BDSI's headquarters is located inRaleigh, North Carolina. For more
BDSI^®and BEMA^®are registered trademarks of BioDelivery Sciences
International, Inc. The BioDelivery Sciences logo and BUNAVAIL™ are
trademarks owned by BioDelivery Sciences International, Inc. ONSOLIS^®is a
registered trademark of Meda Pharmaceuticals, Inc. BREAKYL™ is a trademark
owned by Meda Pharma GmbH & Co. KG. PAINKYL^TMis a trademark owned by TTY
Biopharm. All other trademarks and tradenames are owned by their respective
Cautionary Note on Forward-Looking Statements
This press release, the presentation described herein, and any 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," "will," "could," "would,"
"should," "believes," "expects," "anticipates," "estimates," "intends,"
"plans," "potential" 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 the Company's clinical,
regulatory and commercialization activities described herein) 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). The Company undertakes no obligation to publicly update
any forward-looking statements, whether as a result of new information, future
events or otherwise, except as required by applicable law.
© BioDelivery Sciences International, Inc. All rights reserved.
SOURCE BioDelivery Sciences International, Inc.
Contact: Brian Korb, Senior Vice President, The Trout Group LLC, (646)
378-2923, firstname.lastname@example.org; Al Medwar, Vice President, Marketing and
Corporate Development, BioDelivery Sciences International, Inc., 919-582-9050,
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