RedHill's
Talicia, the first approved low-dose rifabutin-containing
all-in-one combination treatment for H. pylori, is now available on
prescription to treat adults with H. pylori infection in the
United Arab Emirates (UAE)
The commercial launch of Talicia triggers
RedHill's eligibility for
additional potential milestone payments, minimum sales payments and
tiered royalties up to mid-teens on net sales
Talicia is the leading branded first-line
therapy prescribed by U.S.
gastroenterologists[1] for the
treatment of H. pylori, a bacterial infection that affects 41% of
the UAE population[2] and over 50% of
the world's adult population[3]
RALEIGH,
N.C., Aug. 21, 2024 /PRNewswire/ -- RedHill
Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty
biopharmaceutical company, today announced the launch of Talicia
(omeprazole magnesium, amoxicillin and
rifabutin)[4] in the United Arab Emirates (UAE) – making it
available by prescription to treat adults with Helicobacter
pylori (H. pylori) infection. The commercial launch of
Talicia in the UAE triggers RedHill's eligibility for additional potential
milestone payments, minimum sales payments and tiered royalties up
to mid-teens on net sales. Talicia is the first approved low-dose
rifabutin-containing all-in-one combination product in the UAE
specifically designed to treat H. pylori.
"We are delighted with the commercial launch of Talicia in the
UAE, bringing this important medicine to patients in the region,"
said Rick Scruggs, President,
RedHill Biopharma Inc. & Chief Commercial Officer. "As
one of the strongest risk factors for gastric cancer, H.
pylori is a major public health concern. With 41% of the UAE
population infected by H. pylori and the alarming failure
rates of clarithromycin-based therapies[5],[6], there is
a significant medical need for a highly effective first-line H.
pylori therapy. Our efforts to make Talicia available to
patients in more countries continue as we work to explore
additional opportunities with existing and potential partners."
Clarithromycin-based triple therapy continues to wane in
effectiveness. A 2021 study demonstrated only 68.5% eradication
with traditional clarithromycin-based triple therapy, which
declined further to 32% in patients harboring resistant H.
pylori organisms[7]. Clarithromycin-based
treatment efficacy can also be negatively impacted by patient
obesity or diabetic status, neither of which impact Talicia's
safety or efficacy, according to data from post-approval post-hoc
analysis[8],[9].
About H. pylori
H. pylori is a bacterial
infection that affects approximately 35%[10]
of the U.S. population, with an estimated two million patients
treated annually[11]. Worldwide, more than
50% of the population has H. pylori infection, which is
classified by the WHO as a Group 1 carcinogen. It remains the
strongest known risk factor for gastric
cancer[12] and a major risk factor for
peptic ulcer disease[13] and gastric
mucosa-associated lymphoid tissue (MALT)
lymphoma[14]. More than 27,000 Americans are
diagnosed with gastric cancer annually[15].
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 therapies[16].
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. The high
rates of H. pylori resistance to clarithromycin have led to
significant rates of treatment failure with clarithromycin-based
therapies and are a strong public health concern, as highlighted by
the ACG, FDA and the World Health Organization (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
adherent[17] to their therapy had response
rates of 90.3% in the Talicia® arm vs. 64.7% in the
active comparator arm[18].
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
adults[19], and Aemcolo®,
for the treatment of travelers' diarrhea in
adults[20]. 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 / twitter.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, including,
but not limited to, statements regarding the intended use of net
proceeds from the offering, may be preceded by the words "intends,"
"may," "will," "plans," "expects," "anticipates," "projects,"
"predicts," "estimates," "aims," "believes," "hopes," "potential"
or similar words and include statements regarding the risk that the
Company will not comply with the listing requirements of the Nasdaq
Capital Market ("Nasdaq") to remain listed for trading on Nasdaq,
the addition of new revenue generating products, out-licensing of
the Company's development pipeline assets, timing of opaganib's
development for Acute Radiation Syndrome, non-dilutive development
funding from RHB-107 and its inclusion in a key platform study.
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 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
HB-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, 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, as well as risks and uncertainties associated with 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.
Category: Commercial
Logo:
https://mma.prnewswire.com/media/1334141/RedHill_Biopharma_Logo.jpg
Company contact:
Adi
Frish
Chief Corporate & Business Development
Officer
RedHill Biopharma
adi@redhillbio.com
+972-54-6543-112
[1] IQVIA XPO Data on file
[2] Khoder G, Muhammad JS, Mahmoud I, Soliman SSM, Burucoa C.
Prevalence of Helicobacter pylori and Its Associated Factors
among Healthy Asymptomatic Residents in the United Arab Emirates. Pathogens. 2019;8(2):44.
Published 2019 Apr 1. doi:10.3390/pathogens8020044
[3] Hooi JKY et al. Global Prevalence of Helicobacter pylori
Infection: Systematic Review and Meta-Analysis. Gastroenterology
2017; 153:420-429.
[4] 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.
[5] Savoldi, A., et al., Prevalence of Antibiotic Resistance
in Helicobacter pylori: A Systematic Review and
Meta-analysis in World Health Organization Regions.
Gastroenterology, 2018. 155(5): p. 1372-1382 e17.
[6] Park, J.Y., et al., Helicobacter pylori
Clarithromycin Resistance and Treatment Failure Are Common in the
USA. Dig Dis Sci, 2016. 61(8): p.
2373-2380.
[7] Chey, W.D., et al., Vonoprazan Triple and Dual Therapy for
Helicobacter pylori Infection in the United States and Europe: Randomized Clinical Trial.
Gastroenterology, 2022. 163(3): p. 608-619.
[8] Diabetes Data on File
[9] Kao, J.Y., Helicobacter pylori eradication by
low-dose rifabutin triple therapy (RHB-105) is unaffected by high
body mass index. GastroHep, 2021. 3(7): p. 426-434.
[10] Hooi JKY et al. Global Prevalence of Helicobacter
pylori Infection: Systematic Review and Meta-Analysis.
Gastroenterology 2017; 153:420-429.
[11] IQVIA Custom Study for RedHill Biopharma, 2019
[12] 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.
[13] NIH – Helicobacter pylori and Cancer, September
2013.
[14] 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.
[15] National Cancer Institute, Surveillance, Epidemiology, and End
Results Program (SEER).
[16] 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.
[17] 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.
[18] 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).
[19] 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.
[20] 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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SOURCE RedHill Biopharma Ltd.