TEL AVIV, Israel and
RALEIGH, N.C., Dec. 7, 2020 /PRNewswire/ -- RedHill
Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a
specialty biopharmaceutical company, today announced that it has
increased unrestricted national and regional commercial coverage
for Talicia® (omeprazole magnesium, amoxicillin and
rifabutin) to more than 40 million additional
"With this addition of unrestricted coverage for over 40 million
more lives, Talicia is now available to over 70% of commercial
lives. The unrestricted commercial coverage achieved for Talicia to
date far exceeds our expectations at such an early stage following
the product's launch. We continue to work diligently to increase
unrestricted coverage of Talicia, in an effort to make a
significant difference in ending sub-optimal treatment of H.
pylori," said Rick Scruggs,
RedHill's Chief Commercial Officer. "Antibiotic resistance
is a major issue in the treatment of H. pylori infections
and yet, despite current guideline recommendations from the
American College of Gastroenterology calling for use of the most
effective first-line treatment, physicians are still prescribing
treatment regimens containing antibiotics such as clarithromycin
that face high levels of bacterial resistance. This growth in
unrestricted commercial access helps change that dynamic by
increasing access to Talicia to more than 167 million
RedHill has previously announced listings of Talicia as a
preferred brand on the national formularies of Prime Therapeutics,
EnvisionRx, and Express Scripts.
About Talicia (omeprazole magnesium, amoxicillin and
Talicia is the only rifabutin-based therapy approved for the
treatment of H. pylori infection and is designed to address
the high resistance of H. pylori bacteria to
clarithromycin-based standard-of-care therapies. The high rates of
H. pylori resistance to clarithromycin have led to
significant rates of treatment failure with clarithromycin-based
standard-of-care therapy and are a strong public health concern, as
highlighted by the FDA and the World Health Organization (WHO) in
Talicia is a novel, fixed-dose, all-in-one oral capsule
combination of two antibiotics (amoxicillin and rifabutin) and a
proton pump inhibitor (PPI) (omeprazole). In November 2019, Talicia was approved by the U.S.
FDA for the treatment of H. pylori infection in adults. In
the pivotal Phase 3 study, Talicia demonstrated 84%
eradication of H. pylori infection in the intent-to-treat
(ITT) group vs. 58% in the active comparator arm (p<0.0001).
Minimal to zero resistance to Talicia was detected in RedHill's
pivotal Phase 3 study. Further, in an analysis of data from this
study, it was observed that subjects who were confirmed
adherent to their therapy had response rates of 90.3%
in the Talicia arm vs. 64.7% in the active comparator
Talicia is eligible for a total of eight years of post-approval
U.S. market exclusivity under both its Qualified Infectious Disease
Product (QIDP) designation and New Clinical Investigation
exclusivities. In addition, Talicia is protected by a robust U.S.
patent portfolio which provides patent protection until at least
2034, with additional patents and applications pending and granted
in various territories worldwide.
About H. pylori
H. pylori bacterial infection affects approximately
35% of the U.S. population, with an estimated
two million patients treated annually. Worldwide,
more than 50% of the population is affected by H. pylori
infection, which is classified by the WHO as a Group 1 carcinogen,
remains the strongest known risk factor for gastric
cancer and a major risk factor for peptic ulcer
disease and gastric mucosa-associated lymphoid
tissue (MALT) lymphoma. More than 27,000 Americans
are diagnosed with gastric cancer annually, while
eradication of H. pylori has been shown to reduce the risk
of gastric cancer by up to 75%. Eradication
of H. pylori is becoming increasingly difficult,
with current standard-of-care therapies failing in approximately
25-40% of patients who remain H. pylori-positive due to
high resistance of H. pylori to antibiotics
commonly used in standard combination therapies.
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-104, with positive results from a first Phase 3
study for Crohn's disease; (iv) 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; (v) RHB-107
(upamostat), a Phase 2-stage serine protease inhibitor with
a planned Phase 2/3 study in symptomatic COVID-19 and targeting
multiple other cancer and inflammatory gastrointestinal diseases;
and (vi) RHB-106, an encapsulated bowel preparation.
More information about the Company is available at
IMPORTANT SAFETY INFORMATION
Talicia contains omeprazole, a proton pump inhibitor (PPI),
amoxicillin, a penicillin-class antibacterial, and rifabutin, a
rifamycin antibacterial. It is contraindicated in patients with
known hypersensitivity to any of these medications, any other
components of the formulation, any other beta-lactams or any other
Talicia is contraindicated in patients receiving delavirdine,
voriconazole or rilpivirine-containing products.
Serious and occasionally fatal hypersensitivity reactions have
been reported with omeprazole, amoxicillin and rifabutin.
Acute Tubulointerstitial Nephritis has been observed in patients
taking PPIs and penicillins.
Clostridioides difficile-associated diarrhea has been
reported with use of nearly all antibacterial agents and may range
from mild diarrhea to fatal colitis.
Talicia may cause fetal harm and is not recommended for use in
pregnancy. It may also reduce the efficacy of hormonal
contraceptives. An additional non-hormonal method of contraception
is recommended when taking Talicia.
Talicia should not be used in patients with hepatic impairment
or severe renal impairment.
Cutaneous lupus erythematosus and systemic lupus erythematosus
have been reported in patients taking PPIs. These events have
occurred as both new onset and exacerbation of existing autoimmune
The most common adverse reactions (≥1%) were diarrhea, headache,
nausea, abdominal pain, chromaturia, rash, dyspepsia, oropharyngeal
pain, vomiting, and vulvovaginal candidiasis.
To report SUSPECTED ADVERSE REACTIONS, contact RedHill Biopharma
1-833-ADRHILL (1-833-237-4455) or FDA at 1-800-FDA-1088 or
Full prescribing information for Talicia is available
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 Company will be unable to
secure additional pharmacy benefit management's formulary coverage
for Talicia®, as well as other 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 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, including the development of a
commercial companion diagnostic for the detection of MAP; (iii) the
lack of sufficient financial resources which may result in material
adverse impact on the Company's research, manufacturing,
preclinical studies, clinical trials, and other therapeutic
candidate development activities including delay or termination of
preclinical or clinical activities or of any other such activities
(iv) the Company's ability to advance its therapeutic candidates
into clinical trials or to successfully complete its preclinical
studies or clinical trials (v) 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; (vi) the manufacturing, clinical development,
commercialization, and market acceptance of the Company's
therapeutic candidates and commercial products; (vi) the Company's
ability to successfully commercialize and promote
Talicia®, and Aemcolo® and
Movantik®; (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 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, pre-clinical 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 experiences using investigative drugs
under the Company's Expanded Access Program; (xv) competition from
other companies and technologies within the Company's industry; and
(xvi) the hiring and maintaining employment 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 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.
1. Talicia® (omeprazole magnesium,
amoxicillin and rifabutin) delayed-release capsules 10 mg/250
mg/12.5 mg is indicated for the treatment of Helicobacter
pylori (H. pylori) infection in adults. For full
prescribing information see: www.Talicia.com.
2. Defined as the PK population which included
those subjects in the ITT population who had demonstrated presence
of any component of investigational drug at visit 3 (approx. day
13) or had undetected levels drawn >250 hours after the last
3. The pivotal Phase 3 study with
Talicia® demonstrated 84% eradication of H.
pylori infection with Talicia® vs. 58% in the active
comparator arm (ITT analysis, p<0.0001).
4. Hooi JKY et al. Global Prevalence of Helicobacter
pylori Infection: Systematic Review and Meta-Analysis.
Gastroenterology 2017; 153:420-429.
5. IQVIA Custom Study for RedHill Biopharma,
6. Lamb A et al. Role of the Helicobacter
pylori–Induced inflammatory response in the development of
gastric cancer. J Cell Biochem 2013;114.3:491-497.
7. NIH – Helicobacter pylori and Cancer,
8. Hu Q et al. Gastric mucosa-associated lymphoid
tissue lymphoma and Helicobacter pylori infection: a review
of current diagnosis and management. Biomarker research
9. National Cancer Institute, Surveillance,
Epidemiology, and End Results Program (SEER).
10. Kumar S et al. Risk Factors and Incidence of
Gastric Cancer After Detection of Helicobacter pylori Infection: A
Large Cohort Study. Gastroenterology 2020; 158: 527-536.
11. Malfertheiner P. et al. Management
of Helicobacter pylori infection - the Maastricht
IV/ Florence Consensus Report, Gut 2012;61:646-664; O'Connor A. et
al. Treatment of Helicobacter pylori Infection
2015, Helicobacter 20 (S1) 54-61; Venerito M. et al. Meta-analysis
of bismuth quadruple therapy versus clarithromycin triple therapy
for empiric primary treatment of Helicobacter
pylori infection. Digestion 2013;88(1):33-45.
12. Full prescribing information for
Movantik® (naloxegol) is available at:
13. Full prescribing information for
Talicia® (omeprazole magnesium, amoxicillin and
rifabutin) is available at: www.Talicia.com.
14. Full prescribing information for
Aemcolo® (rifamycin) is available at:
Chief Corporate & Business Development Officer
Media contact (U.S.):
+1 212 529 2236
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SOURCE RedHill Biopharma Ltd.