TEL AVIV, Israel and
RALEIGH, N.C., March 25, 2021 /PRNewswire/ -- RedHill Biopharma
Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty
biopharmaceutical company, today announced that RedHill Biopharma
Inc., AztraZeneca AB and AstraZenca Pharmaceuticals LP ("AZ") and
Nektar Therapeutics ("Nektar") have entered into a settlement and
license agreement with MSN Pharmaceuticals, Inc. and MSN
Laboratories PVT. LTD. ("MSN") resolving their patent litigation in
the U.S. in response to MSN's Abbreviated New Drug Application
("ANDA") seeking approval by the US. Food and Drug Administration
("FDA") to market a generic version of Movantik® (naloxegol).
RedHill acquired from AstraZeneca in April 2020 the global rights to Movantik,
excluding Europe and Canada.
Under the terms of the settlement agreement, MSN may not sell a
generic version of Movantik in the U.S. until October 1, 2030 (subject to U.S. FDA approval) or
earlier under certain circumstances.
The parties to the settlement agreement have also agreed to file
a stipulation and order of dismissal with the U.S. District Court
for the District of Delaware which
will conclude this litigation with respect to MSN. As required by
law, the parties will submit the settlement agreement to the U.S.
Federal Trade Commission and the U.S. Department of Justice for
review. The settlement with MSN does not end RedHill's ongoing
litigation against the other two ANDA filers.
About RedHill Biopharma
RedHill Biopharma Ltd. (Nasdaq: RDHL) is a specialty
biopharmaceutical company primarily focused on gastrointestinal and
infectious diseases. RedHill promotes the gastrointestinal drugs,
Movantik® for opioid-induced constipation in
adults[1], Talicia® for the
treatment of Helicobacter pylori (H. pylori) infection in
adults[2], and Aemcolo® for
the treatment of travelers' diarrhea in
adults[3]. RedHill's key clinical late-stage
development programs include: (i) RHB-204, with an
ongoing Phase 3 study for pulmonary nontuberculous mycobacteria
(NTM) disease; (ii) opaganib (Yeliva®), a
first-in-class SK2 selective inhibitor targeting
multiple indications with a Phase 2/3 program for COVID-19 and
Phase 2 studies for prostate cancer and cholangiocarcinoma ongoing;
(iii) RHB-107 (upamostat), a serine protease
inhibitor in a U.S. Phase 2/3 study for symptomatic COVID-19, and
targeting multiple other cancer and inflammatory gastrointestinal
diseases; (iv) RHB-104, with positive results from a first
Phase 3 study for Crohn's disease; (v) RHB-102
(Bekinda®), with positive results from a Phase 3
study for acute gastroenteritis and gastritis and positive results
from a Phase 2 study for IBS-D; and (vi) RHB-106, an
encapsulated bowel preparation. More information about the Company
is available at www.redhillbio.com /
https://twitter.com/RedHillBio.
This press release contains "forward-looking statements"
within the meaning of the Private Securities Litigation Reform Act
of 1995. Such statements may be preceded by the words "intends,"
"may," "will," "plans," "expects," "anticipates," "projects,"
"predicts," "estimates," "aims," "believes," "hopes," "potential"
or similar words. Forward-looking statements are based on certain
assumptions and are subject to various known and unknown risks and
uncertainties, many of which are beyond the Company's control and
cannot be predicted or quantified, and consequently, actual results
may differ materially from those expressed or implied by such
forward-looking statements. Such risks and uncertainties associated
with (i) the initiation, timing, progress and results of the
Company's research, manufacturing, preclinical studies, clinical
trials, and other therapeutic candidate development efforts, and
the timing of the commercial launch of its commercial products and
ones it may acquire or develop in the future; (ii) the Company's
ability to advance its therapeutic candidates into clinical trials
or to successfully complete its preclinical studies or clinical
trials (iii) the extent and number and type of additional studies
that the Company may be required to conduct and the Company's
receipt of regulatory approvals for its therapeutic candidates, and
the timing of other regulatory filings, approvals and feedback;
(iv) the risk that the Company will not succeed to complete the
patient recruitment; the risk that the Company will not receive the
relevant data required for benefiting from the Fast Track
designation; the risk that the U.S. Phase 3 clinical study
evaluating RHB-204 will not be successful or, if successful, will
not suffice for regulatory marketing approval without the need for
additional clinical and/or other studies; (v) the manufacturing,
clinical development, commercialization, and market acceptance of
the Company's therapeutic candidates and Talicia®; (vi) the
Company's ability to successfully commercialize and promote
Movantik®, Talicia® and Aemcolo®; (vii) the Company's ability to
establish and maintain corporate collaborations; (viii) the
Company's ability to acquire products approved for marketing in the
U.S. that achieve commercial success and build and sustain its own
marketing and commercialization capabilities; (ix) the
interpretation of the properties and characteristics of the
Company's therapeutic candidates and the results obtained with its
therapeutic candidates in research, preclinical studies or clinical
trials; (x) the implementation of the Company's business model,
strategic plans for its business and therapeutic candidates; (xi)
the scope of protection the Company is able to establish and
maintain for intellectual property rights covering its therapeutic
candidates and commercial products and its ability to operate its
business without infringing the intellectual property rights of
others; (xii) parties from whom the Company licenses its
intellectual property defaulting in their obligations to the
Company; (xiii) estimates of the Company's expenses, future
revenues, capital requirements and needs for additional financing;
(xiv) the effect of patients suffering adverse events using
investigative drugs under the Company's Expanded Access Program;
and (xv) competition from other companies and technologies within
the Company's industry. More detailed information about the Company
and the risk factors that may affect the realization of
forward-looking statements is set forth in the Company's filings
with the Securities and Exchange Commission (SEC), including the
Company's Annual Report on Form 20-F filed with the SEC on
March 4, 2020. All forward-looking
statements included in this press release are made only as of the
date of this press release. The Company assumes no obligation to
update any written or oral forward-looking statement, whether as a
result of new information, future events or otherwise unless
required by law.
Company
contact:
Adi Frish
Chief Corporate &
Business Development Officer
RedHill
Biopharma
+972-54-6543-112
adi@redhillbio.com
|
Media contact
(U.S.):
Bryan
Gibbs
Vice
President
Finn
Partners
+1 212 529
2236
bryan.gibbs@finnpartners.com
|
[1] Full prescribing information for Movantik®
(naloxegol) is available at: www.Movantik.com.
[2] Full prescribing information for Talicia®
(omeprazole magnesium, amoxicillin and rifabutin) is available at:
www.Talicia.com.
[3] Full prescribing information for Aemcolo®
(rifamycin) is available at: www.Aemcolo.com.
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SOURCE RedHill Biopharma Ltd.