TEL-AVIV, Israel and
RALEIGH, N.C., July 13, 2021 /PRNewswire/ -- 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[i],
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
|
[i] Full prescribing information for Movantik®
(naloxegol) is available at: www.Movantik.com.
[ii] Full prescribing information for Talicia®
(omeprazole magnesium, amoxicillin and rifabutin) is available at:
www.Talicia.com.
[iii] Full prescribing information for Aemcolo®
(rifamycin) is available at: www.Aemcolo.com.
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SOURCE RedHill Biopharma Ltd.