RedHill Biopharma's
Movantik®
Added
as Unrestricted
Preferred Brand
To
A
Major National Commercial Formulary
Serving over 30 Million Americans
Movantik®
included
as preferred
brand
with
no
restrictions
on
a
National
Formulary
of
one of America's largest payors
as
of July 1st
2021
--
Major
national
payor serves
many
Blue
Cross and Blue Shield plans
and more than 30
million
members nationally
--
Movantik's
total commercial coverage now extends to 152
million
American
patients'
lives
--
Movantik
is the
U.S.
market-leading
oral
peripherally acting mu-opioid receptor antagonist
(PAMORA),
approved
to treat opioid-induced
constipation in
adults
with
chronic non-cancer pain
TEL-AVIV,
Israel and RALEIGH, N.C., July 13,
2021
-- InvestorsHub NewsWire -- RedHill
Biopharma Ltd. (Nasdaq:
RDHL) ("RedHill" or the
"Company"), a specialty
biopharmaceutical company, today
announced that
one of
America's largest
payors,
serving
many
Blue Cross and Blue
Shield Plans and more than
30
million
members, has added
Movantik®
(naloxegol),
a peripherally acting
mu-opioid receptor antagonist (PAMORA) for opioid-induced
constipation (OIC), as a
preferred
brand with no
restrictions to a
National
Formulary and
as a preferred
brand on
its other
commercial formularies starting July 1,
2021.
"Chronic
pain is a major public health issue and the debilitating
constipation that often accompanies treatment with opioids only
serves to compound the issue. It is important for optimal therapy
that patients have access to treatments such as
Movantik, the
market-leading PAMORA for opioid-induced
constipation," said
Rick
Scruggs,
RedHill's Chief
Commercial Officer.
"This
important new listing
as an unrestricted
preferred brand strengthens Movantik's leadership position
and now means
that over
30
million more
Americans will have
access to Movantik. Almost
9 out
of 10
U.S.
commercial
lives are
now covered
and we
continue to work toward additional
formulary coverage
for the remaining
patients."
About
Movantik®
(naloxegol)
Movantik® is an
opioid antagonist indicated for the treatment of
opioid-induced
constipation (OIC) in adult patients with chronic non-cancer pain,
including patients with chronic pain related to prior cancer or its
treatment who do not require frequent (e.g., weekly) opioid dosage
escalation.
Important
Safety Information About Movantik
Movantik®
(naloxegol) is
contraindicated in:
-
Patients with known
or suspected gastrointestinal (GI) obstruction and patients at risk
of recurrent obstruction, due to the potential for GI
perforation.
-
Patients receiving
strong CYP3A4 inhibitors (e.g., clarithromycin, ketoconazole)
because these medications can significantly increase exposure to
naloxegol which may precipitate opioid withdrawal
symptoms.
-
Patients with a known
serious or severe hypersensitivity reaction to Movantik or any of
its excipients.
Symptoms consistent
with opioid withdrawal, including hyperhidrosis, chills,
diarrhea, abdominal
pain, anxiety, irritability, and yawning, occurred in
patients treated with
Movantik. Patients receiving methadone as therapy for their
pain condition were
observed in the clinical trials to have a higher frequency of
GI adverse reactions
that may have been related to opioid withdrawal than
patients receiving other
opioids. Patients with disruptions to the blood-brain barrier may
be at increased risk for opioid withdrawal or reduced analgesia.
These patients (e.g., multiple sclerosis, recent brain injury,
Alzheimer's disease, and uncontrolled epilepsy) were not enrolled
in the clinical studies. Take into
account the overall
risk-benefit profile when using Movantik in such patients. Monitor
for symptoms of opioid withdrawal when using Movantik in such
patients.
Severe abdominal pain
and/or diarrhea have been reported, generally within a few
days of initiation of
Movantik. Monitor and discontinue if severe symptoms occur.
Consider restarting Movantik at 12.5 mg once daily.
Cases of GI
perforation have been reported with the use of peripherally acting
opioid antagonists,
including Movantik. Post-marketing
cases of GI
perforation, including fatal cases, were reported
when Movantik was used in patients at risk of GI perforation
(e.g., infiltrative
gastrointestinal tract malignancy, recent gastrointestinal tract
surgery, diverticular disease including
diverticulitis, ischemic colitis, or concomitantly treated
with bevacizumab). Monitor
for severe, persistent, or worsening abdominal pain; discontinue
if this symptom
develops.
The most common
adverse reactions with Movantik as compared to placebo
in clinical trials
were: Abdominal pain (21% vs 7%), diarrhea (9% vs 5%),
nausea (8% vs 5%),
flatulence (6% vs 3%), vomiting (5% vs 4%), headache (4% vs
3%), and hyperhidrosis (3%
vs <1%).
Movantik (naloxegol)
is indicated for the treatment of opioid-induced constipation (OIC)
in adult patients with chronic non-cancer pain,
including patients with chronic pain related to prior cancer or its
treatment who do not require frequent (e.g., weekly) opioid dosage
escalation.
Click here for
the Medication
Guide and
full Prescribing
Information for
Movantik.
You are encouraged to
report Adverse Reactions to RedHill Biopharma Inc.
at 1-833-ADRHILL (1-833-237-4455) or FDA
at 1-800-FDA-1088 or www.fda.gov/medwatch.
MOVANTIK is a
registered trademark of the AstraZeneca group of
companies.
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, Talicia®
for the treatment
of Helicobacter
pylori (H. pylori) infection in
adults[ii], and
Aemcolo®
for the treatment of
travelers' diarrhea in adults[iii]. 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
(ABC294640), a
first-in-class SK2
selective inhibitor targeting multiple indications with positive
Phase 2 COVID-19 data and an ongoing 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 as treatment 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 include,
without limitation; the risk that the Company will be unable to
secure additional
PBMs formulary coverage for Movantik,;
as well as risks and uncertainties associated with (i) the
initiation,
timing, progress and results of the Company's research,
manufacturing, pre-clinical 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 pre-clinical studies or clinical trials
or the development of a commercial companion diagnostic for the
detection of MAP; (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 manufacturing, clinical development,
commercialization, and market acceptance of the Company's
therapeutic candidates and Talicia®;
(v) the Company's ability to successfully commercialize and promote
Talicia®,
and Aemcolo®
and Movantik®;
(vi) the Company's ability to establish and maintain corporate
collaborations; (vii) the Company's ability to acquire products
approved for marketing in the U.S. that achieve commercial success
and build its own marketing and commercialization capabilities;
(viii) the interpretation of the properties and characteristics of
the Company's therapeutic candidates and the results obtained with
its therapeutic candidates in research, pre-clinical studies or
clinical trials; (ix) the implementation of the Company's business
model, strategic plans for its business and therapeutic candidates;
(x) the scope of protection the Company is able to establish and
maintain for intellectual property rights covering its therapeutic
candidates and its ability to operate its business without
infringing the intellectual property rights of others; (xi) parties
from whom the Company licenses its intellectual property defaulting
in their obligations to the Company; (xii) estimates of the
Company's expenses, future revenues, capital requirements and needs
for additional financing; (xiii) the effect of patients suffering
adverse experiences using investigative drugs under the Company's
Expanded Access Program; (xiv) competition from other companies and
technologies within the Company's industry; and (xv) the hiring and
employment commencement date of executive managers. 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 contacts:
U.S.: Bryan
Gibbs, Finn
Partners
+1 212
529 2236
bryan.gibbs@finnpartners.com
UK: Amber
Fennell, Consilium
+44 (0)
7739 658 783
fennell@consilium-comms.com