TEL AVIV, Israel and
RALEIGH, N.C., Feb. 18, 2021 /PRNewswire/ -- RedHill Biopharma
Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty
biopharmaceutical company, today announced agreements with Cosmo
Pharmaceuticals NV (SIX: COPN) ("Cosmo") to manufacture two key
products; RedHill's largest selling product in the U.S.,
Movantik®, and RHB-204, currently in a Phase 3 U.S.
study as a stand-alone, first-line orally-administered treatment
for pulmonary nontuberculous mycobacteria (NTM) disease.
"Movantik is currently our biggest commercial product. This
agreement strengthens our qualified supply base and capacity moving
forward and solidifies our ongoing strategic relationship with
Cosmo," said Steven Thomasian,
RedHill's Vice President of Supply Chain Management.
"We are happy to strengthen our partnership with RedHill with
the manufacturing of these two important products and therefore to
further expand Cosmo's production capacities and capabilities,"
said Davide Malavasi, Cosmo's
Head of Manufacturing.
Movantik is the leading prescribed oral peripherally acting
mu-opioid receptor antagonist (PAMORA) in the U.S. specifically
designed to treat opioid-induced constipation (OIC) in adult
patients with chronic non-cancer pain. OIC is the most common
and debilitating gastrointestinal adverse effect associated with
opioid therapy, estimated to affect between 40-80% of the millions
of patients taking chronic opioid therapy each year.
RHB-204 is an investigational proprietary, fixed-dose oral
capsule containing a combination of clarithromycin, rifabutin, and
clofazimine, developed as a stand-alone first-line treatment for
pulmonary NTM disease caused by Mycobacterium avium Complex
(MAC). Although rare, the incidence and prevalence of pulmonary NTM
disease are increasing in many areas of the world. There were an
estimated 110,000 pulmonary NTM disease patients in the U.S. in
2017, with U.S. market potential estimated at over $500 million. RHB-204 has received FDA Fast
Track, Orphan Drug and QIDP designations aimed at accelerating
development and FDA review and extending U.S. market exclusivity to
a potential total of 12 years, to be granted at the time of FDA
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, and Aemcolo® for
the treatment of travelers' diarrhea in
adults. 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 /
About Cosmo Pharmaceuticals
Cosmo is a specialty pharmaceutical company focused on
developing and commercializing products to treat selected
gastrointestinal disorders and improve endoscopy quality measures
through aiding the detection of colonic lesions. Cosmo has also
developed medical devices for endoscopy and has recently entered
into a partnership with Medtronic for the global distribution of GI
Genius™ its artificial intelligence device for use in coloscopies
and GI procedures. Cosmo has licensed Aemcolo® to
RedHill Biopharma for the US and has licensed Relafalk®
to Dr. Falk Gmbh for the EU and other countries. For additional
information on Cosmo and its products please visit the Company's
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 (eg,
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 patient (eg,
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 (eg, 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
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.
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, including
without limitation, the risk that the agreement with Cosmo will not
provide high-quality manufacturing capacity for
Movantik® and RHB-204 or be sufficient to meet market
demands, as well as other 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.
Chief Corporate &
Business Development Officer
+1 212 529
 Since Jan 2017. IQVIA NPA
 Crockett, Seth D., et al. American Gastroenterological
Association Institute guideline on the medical management of
opioid-induced constipation, Gastroenterology 156.1 (2019):
 Henkle E, et al. Population-based Incidence of
Pulmonary Nontuberculous Mycobacterial Disease in Oregon 2007 to 2012 Annals of the American
Thoracic Society. 2015; 12(5):642-7.
 Foster|Rosenblatt, 2017.
 Full prescribing information for Movantik®
(naloxegol) is available at: www.Movantik.com.
 Full prescribing information for Talicia®
(omeprazole magnesium, amoxicillin and rifabutin) is available at:
 Full prescribing information for Aemcolo®
(rifamycin) is available at: www.Aemcolo.com.
SOURCE RedHill Biopharma Ltd.