Medi-Cal, California's Medicaid healthcare program, and
RedHill have renewed their contract to maintain Talicia's
first-line position on the Medi-Cal Fee-For-Service (FFS) Contract
Drug List (CDL) with no prior authorization and a $0 copay – a major benefit for approximately
fifteen million Californian Medi-Cal patients
--
The renewed terms reflect both parties'
ongoing commitment to improving patient access and outcomes,
reinforcing Talicia's role as an essential treatment option, and
follow the new American College of Gastroenterology (ACG) Clinical
Guideline1 for H. pylori infection,
listing Talicia as an empirically prescribed first-line
option
--
Talicia's convenient all-in-one three-times
daily (TID) formulation offers a simplified patient experience,
supporting high rates of H. pylori eradication without the
requirement of prior resistance testing, and continues to be the
branded H. pylori therapy most prescribed by U.S.
gastroenterologists2
--
H. pylori infection affects approximately 35%
of the U.S. adult population3 and is classified
by the World Health Organization (WHO) as a Group 1 carcinogen,
being the strongest known risk factor for gastric
cancer4 and a major risk factor for peptic ulcer
disease5
RALEIGH,
N.C. and TEL AVIV,
Israel, Oct. 1, 2024 /PRNewswire/ -- RedHill
Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a
specialty biopharmaceutical company, today announced the renewal of
its contract with Medi-Cal, California's Medicaid healthcare program, to
maintain Talicia's first-line position on the Medi-Cal
Fee-For-Service (FFS) Contract Drug List (CDL) with no prior
authorization and a $0 copay,
effective October 1, 2024.
"This renewed agreement with Medi-Cal is great news for the
approximately 15 million Californian patients who rely on Medi-Cal
and represents a clear vote of confidence in the safety and
efficacy of Talicia, which has been listed by Medi-Cal since 2021,"
said Rick D. Scruggs, President
and Chief Commercial Officer of RedHill Biopharma, Inc. "The
continuing access to Talicia further reflects the strength of our
collaboration and aligned commitment to improving patient care.
This agreement comes in the wake of the publication of the new
American College of Gastroenterology (ACG) Clinical Guideline for
H. pylori infection, listing Talicia as an empirically
prescribed first-line option – a clear scientific validation of
Talicia's effective, simple and convenient all-in-one three-times
daily (TID) therapeutic approach, supporting high rates of H.
pylori eradication without the need for prior resistance
testing."
About H. pylori
H.
pylori is a bacterial infection that affects approximately
35%6 of the U.S. population, with an estimated two
million patients treated annually3. Worldwide, around 66% of the
population has H. pylori infection7, which is
classified by the World Health Organization (WHO) as a Group 1
carcinogen. It remains the strongest known risk factor for gastric
cancer8 and a major risk factor for peptic ulcer
disease9 and gastric mucosa-associated lymphoid tissue
(MALT) lymphoma10. More than 27,000 Americans are
diagnosed with gastric cancer annually11. Eradication of
H. pylori is becoming increasingly difficult, with
current therapies failing in approximately 25-40% of patients who
remain H. pylori-positive due to high resistance
of H. pylori to antibiotics – especially
clarithromycin – which is still commonly used in standard
combination therapies12.
About Talicia®
Talicia® is the only low-dose rifabutin-based therapy
approved for the treatment of H. pylori infection and is
designed to address the high resistance of H. pylori
bacteria seen with other antibiotics. More specifically, the high
rates of H. pylori resistance to clarithromycin have led to
significant increases in treatment failures with
clarithromycin-based therapies and are a strong public health
concern, as highlighted by the ACG, FDA and the WHO in recent
years.
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 rifabutin, a key
component of 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 adherent13 to
their therapy had response rates of 90.3% in the
Talicia® arm vs. 64.7% in the active comparator
arm14.
Talicia® is eligible for a total of eight years of U.S.
market exclusivity under its Qualified Infectious Disease Product
(QIDP) designation and is also covered by U.S. patents which extend
patent protection until 2034 with additional patents and
applications pending and granted in various territories
worldwide.
TALICIA: INDICATION AND IMPORTANT SAFETY
INFORMATION
Talicia is a three-drug combination of
omeprazole, a proton pump inhibitor, amoxicillin, a
penicillin-class antibacterial, and rifabutin, a rifamycin
antibacterial, indicated for the treatment
of Helicobacter pylori infection in
adults.
To reduce the development of drug-resistant bacteria and maintain
the effectiveness of Talicia and other antibacterial drugs, Talicia
should be used only to treat or prevent infections that are proven
or strongly suspected to be caused by bacteria.
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
rifamycin.
Talicia is contraindicated in patients receiving
rilpivirine-containing products.
Talicia is contraindicated in patients receiving delavirdine or
voriconazole.
Serious and occasionally fatal hypersensitivity reactions have been
reported with omeprazole, amoxicillin and rifabutin.
Drug-induced enterocolitis syndrome (DIES) has been reported with
use of amoxicillin, a component of Talicia.
Severe cutaneous adverse reactions (SCAR) (e.g., Stevens-Johnson
syndrome (SJS), Toxic epidermal necrolysis (TEN)) have been
reported with rifabutin, amoxicillin, and omeprazole. Additionally,
drug reaction with eosinophilia and systemic symptoms (DRESS) has
been reported with rifabutin.
Acute Tubulointerstitial Nephritis has been observed in patients
taking PPIs and penicillins.
Clostridioides difficile-associated diarrhea (CDAD) has been
reported with use of nearly all antibacterial agents and may range
from mild diarrhea to fatal colitis.
Talicia may cause fetal harm. Talicia is not recommended for use in
pregnancy. Talicia may 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 (CLE) and systemic lupus
erythematosus (SLE) have been reported in patients taking PPIs.
These events have occurred as both new onset and exacerbation of
existing autoimmune disease.
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
INC. at 1-833-ADRHILL (1-833-237-4455) or FDA at 1-800-FDA-1088 or
www.fda.gov/medwatch.
Full prescribing information for Talicia is available
at www.Talicia.com.
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 Talicia®, for
the treatment of Helicobacter pylori (H. pylori)
infection in adults15, and Aemcolo®,
for the treatment of travelers' diarrhea in adults16.
RedHill's key clinical late-stage development programs include:
(i) opaganib (ABC294640), a
first-in-class oral broad-acting, host-directed SPHK2
selective inhibitor with potential for pandemic preparedness,
targeting multiple indications with a U.S. government collaboration
for development for Acute Radiation Syndrome (ARS), a Phase 2/3
program for hospitalized COVID-19, and a Phase 2 program in
oncology; (ii) RHB-107 (upamostat), an oral
broad-acting, host-directed, serine protease inhibitor with
potential for pandemic preparedness is in late-stage development as
a treatment for non-hospitalized symptomatic COVID-19, with
non-dilutive external funding covering the entirety of the RHB-107
arm of the 300-patient Phase 2 adaptive platform trial, and is also
targeting multiple other cancer and inflammatory gastrointestinal
diseases; (iii) RHB-102, with potential UK submission
for chemotherapy and radiotherapy induced nausea and vomiting,
positive results from a Phase 3 study for acute gastroenteritis and
gastritis and positive results from a Phase 2 study for IBS-D;
(iv) RHB-104, with positive results from a first Phase
3 study for Crohn's disease; and (v) RHB-204, a
Phase 3-stage program for pulmonary nontuberculous mycobacteria
(NTM) disease.
More information about the Company is available at
www.redhillbio.com / X.com/RedHillBio.
Forward Looking Statements
This press release
contains "forward-looking statements" within the meaning of the
Private Securities Litigation Reform Act of 1995 and may discuss
investment opportunities, stock analysis, financial performance,
investor relations, and market trends. Such statements may be
preceded by the words "intends," "may," "will," "plans," "expects,"
"anticipates," "projects," "predicts," "estimates," "aims,"
"believes," "hopes," "potential" or similar words and include,
among others, statements regarding the potential effects of
Talicia® in the treatment of Helicobacter pylori
infection. 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: market and other conditions; the Company's
ability to maintain compliance with the Nasdaq Capital Market's
listing requirements; the risk that the addition of new revenue
generating products or out-licensing transactions will not occur;
the risk that acceptance onto the RNCP Product Development Pipeline
will not guarantee ongoing development or that any such development
will not be completed or successful; the risk that the FDA does not
agree with the Company's proposed development plans for opaganib
for any indication; the risk that observations from preclinical
studies are not indicative or predictive of results in clinical
trials; the risk that the FDA pre-study requirements will not be
met and/or that the Phase 3 study of RHB-107 in COVID-19
outpatients will not be approved to commence or if approved, will
not be completed or, should that be the case, that we will not be
successful in obtaining alternative non-dilutive development
funding for RHB-107; the risk that RHB-107's late-stage development
for non-hospitalized COVID-19 will not benefit from the resources
redirected from the terminated RHB-204 Phase 3 study, and that the
Phase 2/3 COVID-19 study for RHB-107 may not be successful and,
even if successful, such studies and results may not be sufficient
for regulatory applications, including emergency use or marketing
applications, and that additional COVID-19 studies for opaganib and
RHB-107 are likely to be required; the risk that the Company will
not successfully commercialize its products; 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®; (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 April 8, 2024. 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
Category: Commercial
1 Chey, William D. MD, FACG1; Howden, Colin W. MD,
FACG2; Moss, Steven F. MD, FACG3; Morgan, Douglas R. MD, MPH,
FACG4; Greer, Katarina B. MD, MSEpi5; Grover, Shilpa MD, MPH6;
Shah, Shailja C. MD, MPH7. ACG Clinical Guideline: Treatment of
Helicobacter pylori Infection. The American Journal of
Gastroenterology 119(9):p 1730-1753, September 2024. | DOI:
10.14309/ajg.0000000000002968
2 IQVIA XPO Data on file
3 Hooi JKY et al. Global Prevalence of Helicobacter
pylori Infection: Systematic Review and Meta-Analysis.
Gastroenterology 2017; 153:420-429.
4 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.
5 NIH – Helicobacter pylori and Cancer, September
2013.
6 Hooi JKY et al. Global Prevalence of Helicobacter
pylori Infection: Systematic Review and Meta-Analysis.
Gastroenterology 2017; 153:420-429.
7
https://wwwnc.cdc.gov/travel/yellowbook/2024/infections-diseases/helicobacter-pylori
8 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.
9 NIH – Helicobacter pylori and Cancer, September
2013.
10 Hu Q et al. Gastric mucosa-associated lymphoid tissue
lymphoma and Helicobacter pylori infection: a review of
current diagnosis and management. Biomarker research
2016;4.1:15.
11 National Cancer Institute, Surveillance,
Epidemiology, and End Results Program (SEER).
12 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.
13 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 dose.
14 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).
15 Talicia® (omeprazole magnesium,
amoxicillin and rifabutin) is indicated for the treatment of H.
pylori infection in adults. For full prescribing information
see: www.Talicia.com.
16 Aemcolo® (rifamycin) is indicated for the
treatment of travelers' diarrhea caused by noninvasive strains of
Escherichia coli in adults. For full prescribing information
see: www.Aemcolo.com.
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