RedHill's
partner, Gaelan Medical, part of the Ghassan Aboud Group (GAG),
receives marketing approval from the United Arab Emirates (UAE) Ministry of Health
for Talicia
Gaelen placed a meaningful initial Talicia
order and commences commercialization activities
Talicia, a novel rifabutin-containing
all-in-one oral capsule specifically designed to treat H. pylori,
is the leading branded first-line therapy prescribed by U.S.
gastroenterologists[1] for eradication of
H. pylori - a bacterial infection that affects 41% of the UAE adult
population[2]
RALEIGH,
N.C. and TEL-AVIV,
Israel, Aug. 1, 2023 /PRNewswire/ -- RedHill
Biopharma Ltd. (NASDAQ: RDHL) ("RedHill" or the "Company"), a specialty
biopharmaceutical company, announced that its partner, Gaelan
Medical LLC ("Gaelan Medical"), a wholly owned subsidiary of the
Ghassan Aboud Group (GAG), has received marketing approval from the
United Arab Emirates (UAE)
Ministry of Health for Talicia (omeprazole magnesium, amoxicillin
and rifabutin)[3]. The approval makes Talicia
the first approved rifabutin-containing all-in-one combination
product in the UAE specifically designed to treat H.
pylori.
"We are delighted with the rapid progress our partner, Gaelen
Medical, has made in achieving marketing approval for Talicia in
the UAE, and we are pleased to have received the first commercial
order for Talicia from Gaelen," said Adi
Frish, RedHill's Chief
Corporate & Business Development Officer. "H.
pylori is a major public health concern in the region,
impacting up to 84% of the population[4], and
is one of the strongest risk factors for gastric cancer.
Considering the alarming failure rates of clarithromycin-based
therapies and the need for highly effective first-line H.
pylori therapy, we continue our efforts to help bring Talicia
to H. pylori patients in additional countries as we continue
to explore, with GAG and other potential partners, the expansion of
Talicia's reach into new territories."
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[5]. Other studies have
also shown that for clarithromycin-resistant strains of H.
pylori the risk of eradication failure increases 3-7–fold when
treated with clarithromycin-containing
regimens[6],[7].
Clarithromycin-based treatment efficacy can also be negatively
impacted by patient BMI or diabetic status, neither of which impact
Talicia's eradication rates, according to data from post-approval
post-hoc
analysis[8],[9].
About H. pylori
infection
H. pylori is
a bacterial infection that affects approximately 35%2 of the U.S.
population, with an estimated two million patients treated
annually[10]. 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[11] and a
major risk factor for peptic ulcer
disease[12] and gastric
mucosa-associated lymphoid tissue (MALT)
lymphoma[13]. More than 27,000 Americans are
diagnosed with gastric cancer annually[14].
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[2].
About Talicia
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),
approved by the U.S. FDA for the treatment of H. pylori
infection in adults.
Talicia is the only low-dose rifabutin-based therapy approved
for the treatment of H. pylori infection and is designed to
address H. pylori's high resistance to 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.
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[15] to their therapy had response
rates of 90.3% in the Talicia arm vs. 64.7% in the active
comparator arm[16]. 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.
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: IMPORTANT SAFETY INFORMATION
Tell your healthcare provider about all of the medicines you
take, including prescription or non-prescription medications or
herbal supplements before starting Talicia. Talicia may affect the
way other medicines work, and other medicines may affect the way
Talicia works. Do not start any new medications while taking
Talicia without first speaking with your healthcare provider.
- You should not take Talicia if you are known to be sensitive to
any of the components of Talicia (omeprazole, amoxicillin,
rifabutin), penicillins, proton pump inhibitors or rifamycins.
- You should not take Talicia if you are taking
rilpivirine-containing products, delavirdine or voriconazole.
Before you take Talicia, tell your healthcare provider about
all of your medical conditions, including if you:
- Are pregnant or plan to become pregnant. Talicia may harm your
unborn baby. Tell your healthcare provider if you become pregnant
or think you may be pregnant during your treatment with
Talicia.
- Have severe kidney disease or liver disease.
When taking Talicia, do not crush or chew capsules. Do not
take Talicia with alcohol.
Call your healthcare provider immediately if while taking
Talicia you develop:
- New rash or other skin changes, muscle or joint pains, swelling
of any area of the body, severe flu-like symptoms, difficulty
breathing, fever, blood in your urine, increased or decreased
urination, drowsiness, confusion, nausea, vomiting, ongoing stomach
pain, bloody diarrhea, or if diarrhea continues after therapy is
completed, weight gain or changes in your eyesight.
What are the common side effects of Talicia?
- The most common side effects of Talicia are diarrhea, headache,
nausea, stomach pain, rash, indigestion, mouth or throat pain,
vomiting, and vaginal yeast infection. Call your healthcare
professional for medical advice about side effects.
- Tell your healthcare provider if you experience tiredness,
weakness, achiness, headaches, dizziness, depression, increased
sensitivity to light, or pain when taking a deep breath.
- Talicia may reduce the effectiveness of oral or other forms of
hormonal birth-control. You should use an additional non-hormonal
highly effective method of birth control while taking Talicia.
- You may experience a brown-orange discoloration of your urine
or tears while taking Talicia.
- The information here is not comprehensive. Talk to your
healthcare provider to learn more.
APPROVED USE FOR TALICIA
TALICIA is indicated for the treatment of Helicobacter
pylori infection in adults.
Click here for the full Prescribing Information for
TALICIA.
You are encouraged to report Adverse Reactions to RedHill
Biopharma Inc. at 1-833-ADRHILL (1-833-237-4455) or the FDA at
1-800-FDA-1088 or www.fda.gov/medwatch.
About Gaelan Medical
Gaelan Medical is a part of Ghassan Aboud Group, an
international conglomerate that has been engaged in several key
business sectors including health care, automotive, hospitality,
real estate, retail, catering, logistics, pastoral, trade and
distribution and media for more than two decades. Headquartered in
the United Arab Emirates, GAG's
business operations are complemented by offices in Australia, Belgium, Jordan and Turkey.
Ghassan Aboud Group believes that productivity, innovation and
transformation require community engagement and ensures that its
exclusive portfolio operates in a corporate conscious and a
responsible manner making people the number one priority behind its
vision "Being at the forefront of excellence".
Gaelan Medical, the UAE based healthcare and beauty distribution
business follows a mission of care and cure and is dedicated to
support healthcare providers with world-class solutions to better
serve communities across the GCC region. Gaelan Medical, with its
experienced management team, caters to diverse healthcare needs
including, pharmaceuticals, medical consumables, medical equipment,
and beauty products. The company's flexibility and strong financial
capabilities of its parent company GAG makes it the preferred
partner-of-choice and one stop solution for the region.
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[1], and
Aemcolo® for the treatment of travelers' diarrhea
in adults[17]. 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, 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.
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 not succeed to
achieve additional milestones or royalties on sales or expand
Talicia's reach to additional ex-U.S. territories; as well as other
risk 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; (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; and (xiv) 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 17, 2022. 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] 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
Hooi JKY et al. Global Prevalence of Helicobacter pylori Infection:
Systematic Review and Meta-Analysis. Gastroenterology 2017;
153:420-429.
[3] 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.
[4] Hussein NR. Helicobacter pylori and gastric cancer
in the Middle East: a new enigma?
World J Gastroenterol. 2010;16(26):3226-3234.
doi:10.3748/wjg.v16.i26.3226
Hooi JKY, Lai WY, Ng WK, Suen MMY, Underwood FE, Tanyingoh D, et
al. Global prevalence of Helicobacter pylori infection: systematic
review and meta-analysis. Gastroenterology. 2017 Aug
1;153(2):420–9.
[5] 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.
[6] 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.
[7] 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.
[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] IQVIA Custom Study for RedHill Biopharma, 2019
[11] 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.
[12] NIH – Helicobacter pylori and Cancer,
September 2013.
[13] 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.
[14] National Cancer Institute, Surveillance,
Epidemiology, and End Results Program (SEER).
[15] 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.
[16] 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).
[17] 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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