RALEIGH, N.C., March 31, 2017 /PRNewswire/ -- BioDelivery
Sciences International, Inc. (NASDAQ: BDSI) announced that two
important new patents were granted extending patent protection
around all three of its FDA approved products, BELBUCA®
(buprenorphine) buccal film, BUNAVAIL® (buprenorphine and naloxone)
buccal film, and ONSOLIS® (fentanyl buccal soluble film), further
strengthening BDSI's overall intellectual property position.
In a patent application (US Patent Application Serial No.
15/212,912) covering the composition of the BioErodible
MucoAdhesive (BEMA®) drug delivery technology, which is the basis
for BELBUCA and BUNAVAIL, a Notice of Allowance was issued
providing additional patent coverage for BELBUCA and BUNAVAIL to
July 2027. This patent will be listed
in the Orange Book.
Additionally, a patent (US Patent No. 9,597,288) was issued on
March 21, 2017, which extends patent
protection on ONSOLIS from January
2020 to July 2027. This patent
will also be listed in the Orange Book. The U.S. rights to ONSOLIS
are licensed to Collegium Pharmaceutical. Under the terms of BDSI's
licensing agreement for ONSOLIS with Collegium, the patent grant is
associated with a $3 million
milestone payment to BDSI, the payment of which is due upon U.S.
Food and Drug Administration (FDA) approval of a supplemental
application supporting the new manufacturer for ONSOLIS. This,
along with a $4 million milestone
payment tied to the first commercial sale of ONSOLIS, are
anticipated in the first half of 2018. Under the terms of the
agreement with our former U.S. partner, Meda, the milestones and
future royalties to BDSI will be shared between BDSI and Meda.
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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Internet:
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www.bdsi.com
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Facebook:
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Facebook.com/BioDeliverySI
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@BioDeliverySI
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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, the anticipated
benefits to the Company of the new patents 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.