RedHill Biopharma
Announces Settlement of Movantik® Patent Litigation with
Apotex
TEL
AVIV,
Israel and RALEIGH, NC
-- July 22, 2021 -- InvestorsHub NewsWire -- RedHill
Biopharma Ltd. (Nasdaq:
RDHL) ("RedHill" or the
"Company"), a specialty
biopharmaceutical company, today
announced
that
RedHill Biopharma
Inc., AstraZeneca
AB and AstraZeneca
Pharmaceuticals LP ("AstraZeneca")
and Nektar
Therapeutics
have entered into a
settlement and license
agreement with
Apotex, Inc.
and Apotex
Corp.
("Apotex")
resolving
their
patent
litigation in the U.S.
in response to
Apotex'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,
Apotex
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 Apotex.
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
Apotex
does not end
RedHill's
ongoing litigation
against the other one ANDA
filer.
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, 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 18,
2021.
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
|