RALEIGH, N.C., Oct. 12, 2017 /PRNewswire/ -- BioDelivery
Sciences International, Inc. (NASDAQ: BDSI), a specialty
pharmaceutical company with a focus in pain management and
addiction medicine, today announced that it has entered into a
Settlement Agreement with Teva Pharmaceuticals USA, Inc., Actavis Laboratories UT, Inc. and
Teva Pharmaceuticals Industries, Ltd. (Teva) that resolves BDSI's
previously reported BUNAVAIL® patent litigation against Teva
pending in the United States District Court for the District of
Delaware.
"We are pleased to have resolved this lawsuit with Teva
regarding BUNAVAIL®, as it provides additional certainty to our
patent portfolio, and allows us to move forward while averting
future costs associated with this litigation," said Dr.
Mark A. Mark Sirgo, Vice Chairman,
President and Chief Executive Officer of BioDelivery
Sciences.
BDSI alleged in the lawsuits that the generic form of BUNAVAIL®
(buprenorphine and naloxone) buccal film, which Teva is seeking
approval to market in the United
States pursuant to two Abbreviated New Drug Application
(ANDA) filings with the U.S. Food and Drug Administration (FDA),
infringed upon several U.S. patents owned by BDSI. As part of
the Settlement Agreement, which is subject to review by the U.S.
Federal Trade Commission and the U.S. Department of Justice, BDSI
has entered into a non-exclusive license agreement with Teva that
permits Teva to first begin selling its generic version of
BUNAVAIL® in the U.S. on July 23,
2028 or earlier under certain circumstances. Other
terms of the agreement are confidential.
About BioDelivery Sciences International, Inc.
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 marketed products and those in development address
serious and debilitating conditions such as breakthrough cancer
pain, chronic pain and opioid dependence. BDSI's headquarters
is in Raleigh, North Carolina.
For more information, please visit or follow us:
Internet: www.bdsi.com
Facebook: Facebook.com/BioDeliverySI
Twitter: @BioDeliverySI
BUNAVAIL® (buprenorphine and naloxone) buccal film
(CIII) and BELBUCA® (buprenorphine) buccal film (CIII)
are marketed in the U.S. by BioDelivery Sciences.
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 and for full prescribing and safety
information on BUNAVAIL, please visit
www.bunavail.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,
any anticipated benefits of the Company's settlement with Teva 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®,
BUNAVAIL® and BELBUCA® are registered
trademarks of BioDelivery Sciences International, Inc. The
BioDelivery Sciences, BUNAVAIL and BELBUCA logos are trademarks
owned by BioDelivery Sciences International, Inc. 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.