RALEIGH, N.C., Jan. 9, 2017 /PRNewswire/ -- BioDelivery
Sciences International, Inc. (NASDAQ: BDSI) announced the closing
of its previously announced agreement with Endo Pharmaceuticals,
Inc. (Endo) terminating Endo's licensing of rights for BELBUCA®
(buprenorphine) buccal film (CIII). This transaction follows
a strategic decision announced by Endo in December regarding its
U.S. branded pain business.
As a result of the closing, the worldwide rights to BELBUCA have
now been transferred back to BDSI. The return of BELBUCA
immediately adds additional topline revenue and is expected to be
accretive by improving BDSI's net income and earnings per share in
2017. The recent annual run-rate for BELBUCA gross sales
exceeds $30 million based on the most
recent publicly available monthly sales data.
BDSI plans to initially leverage its existing sales force and
capitalize on commercial synergies with BUNAVAIL for a focused
commercial approach targeting identified healthcare providers which
BDSI believes creates the potential to incrementally grow BELBUCA
sales without the requirement of significant resources. BDSI
will also explore other options for longer-term growth for BELBUCA
both within and outside of the U.S.
BDSI plans to provide additional details on its plans for
BELBUCA at an investor event planned for February 1, 2017, in New York City. The
event will be webcast.
About BioDelivery Sciences International
BioDelivery Sciences International, Inc. (NASDAQ: BDSI) is a
specialty pharmaceutical company with a focus in the areas of pain
management and addiction medicine. BDSI is utilizing its
novel and proprietary BioErodible MucoAdhesive (BEMA®)
technology and other drug delivery technologies to develop and
commercialize, either on its own or in partnership with third
parties, new applications of proven therapies aimed at addressing
important unmet medical needs.
BDSI's development strategy focuses on the utilization of the
FDA's 505(b)(2) approval process. This regulatory pathway creates
the potential for more timely and efficient approval of new
formulations of previously approved therapeutics.
BDSI's area of focus is the development and commercialization of
products in the areas of pain management and addiction. These are
areas where BDSI believes its drug delivery technologies and
products can best be applied to address critical unmet medical
needs. BDSI's marketed products and those in development
address serious and debilitating conditions such as breakthrough
cancer pain, chronic pain, painful diabetic neuropathy and opioid
dependence. BDSI's headquarters is in Raleigh, North
Carolina.
For more information,
please visit or follow us:
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www.bdsi.com
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BUNAVAIL® (buprenorphine and naloxone) buccal film
(CIII) is marketed in the U.S. by BioDelivery Sciences.
BELBUCA® (buprenorphine) buccal film (CIII) is
commercialized in the U.S. by Endo Pharmaceuticals through
January 8, 2017, pursuant to the
worldwide licensing and development agreement between BDSI and
Endo. ONSOLIS® (fentanyl buccal soluble film)
(CII) is licensed in the U.S. to Collegium Pharmaceutical pursuant
to the U.S. licensing and development agreement between BDSI and
Collegium. For full prescribing information and important safety
information on BDSI products, including BOXED WARNINGS for ONSOLIS,
please visit www.bdsi.com where the Company promptly
posts press releases, SEC filings and other important information
or contact the Company at (800) 469-0261. For full
prescribing and safety information on BELBUCA, please visit
www.belbuca.com.
Cautionary Note on Forward-Looking Statements
This press release and any statements of employees,
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 reacquisition of, and
commercialization efforts for BELBUCA as 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 presentations or otherwise, except as required by applicable
law.
BDSI®, BEMA®, ONSOLIS® and
BUNAVAIL® are registered trademarks of BioDelivery
Sciences International, Inc. The BioDelivery Sciences and
BUNAVAIL logos are trademarks owned by BioDelivery Sciences
International, Inc. BELBUCA® is a trademark currently owned
by Endo Pharmaceuticals. All other trademarks and tradenames
are owned by their respective owners.
© 2017 BioDelivery Sciences International, Inc. All rights
reserved.
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SOURCE BioDelivery Sciences International, Inc.