USPTO issues new patent covering Talicia[1]
as a method for eradicating H. pylori regardless of patient Body
Mass Index (BMI)[2], supporting Talicia
protection until May 2042
The patent is supported by previously published pooled data
from two Phase 3 studies showing Talicia's efficacy was unaffected
by presence of elevated BMI[3]
The U.S. FDA recently granted five years' market exclusivity
for Talicia under the Generating Antibiotic Incentives Now (GAIN)
Act Qualified Infectious Disease Product (QIDP) designation,
additional to the three years' exclusivity granted for the approval
of Talicia under section 505(b)(2)
Talicia is the leading branded first-line therapy prescribed
by U.S. gastroenterologists[4] for
eradication of H. pylori - a bacterial infection that affects
approximately 35% of the U.S. adult
population[5]
TEL
AVIV, Israel and RALEIGH, N.C., Jan. 25,
2024 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq:
RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical
company, today announced that the U.S. Patent and Trademark Office
(USPTO) issued a new patent, U.S. Patent No. 11,878,011, covering
Talicia as a method for eradicating Helicobacter
pylori (H. pylori) regardless of patient Body Mass
Index (BMI). This new patent is expected to provide protection for
Talicia until May 2042.
"Rates of obesity continue to rise in the U.S., with over 70% of
the population being overweight or obese[6],
and published data have shown that obesity has been associated with
failure of clarithromycin-based therapies for the treatment of
H. pylori infection. This patent acknowledges the novelty of
the data demonstrating Talicia's ability to remain effective
regardless of patient BMI, awarding this clinically important
innovation with expected patent protection for Talicia until
May 2042" said Gilead Raday, RedHill's Chief Operating Officer,
and Head of R&D.
About H. pylori infection
H.
pylori is a bacterial infection that affects approximately 35%
of the U.S. population, with an estimated two million patients
treated annually[7]. Worldwide, more than 50%
of the population has H. pylori infection, which is
classified by the World Health Organization (WHO) as a Group 1
carcinogen. It remains the strongest known risk factor for gastric
cancer[8] and a major risk factor for
peptic ulcer disease[9] and gastric
mucosa-associated lymphoid tissue (MALT)
lymphoma[10]. More than 27,000 Americans are
diagnosed with gastric cancer annually[11].
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 therapies5.
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. Food and Drug Administration (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 American College of Gastroenterology, the
FDA and the 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[12] to
their therapy had response rates of 90.3% in the Talicia arm vs.
64.7% in the active comparator arm[13]. 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 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[14], and Aemcolo®,
for the treatment of travelers' diarrhea in
adults[15]. 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. 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 comply with
the listing requirements of the Nasdaq Capital Market ("Nasdaq")
to remain listed for trading on Nasdaq; the risk that
the addition of new revenue generating products or out-licensing
transactions will not occur; the risk that the
Company will not succeed to 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 April 28, 2023. 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] 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.
[2] Body mass index (BMI) is a measure of body fat based on height
and weight that applies to adult men and women. It is calculated by
taking a person's weight in kilograms (or pounds) and dividing it
by the square of height in meters (or feet). A high BMI can
indicate high body fatness.
[3]
https://www.redhillus.com/ObesityWeek/2022/RHB-105PBPKObesity/Portenier
[4] IQVIA XPO Data on file
[5] Hooi JKY et al. Global Prevalence of Helicobacter pylori
Infection: Systematic Review and Meta-Analysis. Gastroenterology
2017; 153:420-429.
[6] CDC. Adult Obesity Facts. May 17, 2022. Division of
Nutrition, Physical Activity, and Obesity.
[7] IQVIA Custom Study for RedHill Biopharma, 2019
[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] 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.
[13] 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).
[14] 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.
[15] 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.