U.S. Patent and Trademark Office (USPTO)
issues new patent covering
Talicia1 as an all-in-one
treatment of Helicobacter pylori (H. pylori), supporting Talicia
protection until February 12,
2034
This new patent adds to the existing strong
intellectual property portfolio protecting Talicia, including
composition of matter and other patents and FDA-granted data
exclusivities granted under the GAIN QIDP designation and section
505(b)(2)
Talicia is the only FDA-approved
rifabutin-containing all-in-one therapy for the eradication of H.
pylori, providing an optimized antibiotic resistance profile and
the leading branded first-line therapy prescribed by U.S.
gastroenterologists2 for H.
pylori infection, which affects approximately 35% of the U.S. adult
population3
TEL
AVIV, Israel and RALEIGH,
N.C., March 11, 2024 /PRNewswire/ -- RedHill
Biopharma Ltd. (NASDAQ: RDHL) ("RedHill" or the "Company"), a
specialty biopharmaceutical company, today announced the issue of a
new U.S. patent covering Talicia1 as an all-in-one
fixed-dose combination of amoxicillin, omeprazole and rifabutin and
its use for the treatment of helicobacter pylori (H.
pylori) infection (Patent No. 11,931,463 to be issued
March 19, 20244). Talicia
is the leading branded first-line therapy prescribed by U.S.
gastroenterologists for H. pylori infection, which affects
approximately 35% of the U.S. adult population and this patent is
expected to provide protection for Talicia until February 12, 2034.
"Talicia is the only FDA-approved rifabutin-containing
all-in-one therapy for the eradication of H. pylori. Its
components and formulation are optimized to provide patients with
the right medications for successful H. pylori eradication
with an optimized resistance profile, which is significant in the
face of growing microbial resistance to clarithromycin-based
regimens," said Patricia
Anderson, RedHill's Senior Vice President of Regulatory
Affairs. "The granting of this new U.S. patent further adds to
the strong intellectual property protecting Talicia, including the
recently announced patent for treatment regardless of patient Body
Mass Index (BMI), several other composition of matter and other
patents, and additional FDA-granted data exclusivities granted
under the Generating Antibiotic Incentives Now (GAIN) Act Qualified
Infectious Disease Product (QIDP) designation and the approval of
Talicia under section 505(b)(2)."
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
annually5. 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
cancer6 and a major risk factor for
peptic ulcer disease7 and gastric
mucosa-associated lymphoid tissue (MALT)
lymphoma8. More than 27,000 Americans are
diagnosed with gastric cancer annually9.
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.
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
adherent10 to their therapy had response
rates of 90.3% in the Talicia arm vs. 64.7% in the active
comparator arm11. 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 adults1, and
Aemcolo®, for the treatment of travelers'
diarrhea in adults12. 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 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 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 Patent issued by The United States Patent and
Trademark Office (USPTO), the federal agency for granting U.S.
patents and registering trademarks.
5 IQVIA Custom Study for RedHill Biopharma, 2019
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,
September 2013.
8 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.
9 National Cancer Institute, Surveillance,
Epidemiology, and End Results Program (SEER).
10 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.
11 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).
12 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.
Logo:
https://mma.prnewswire.com/media/1334141/RedHill_Biopharma_Logo.jpg
View original
content:https://www.prnewswire.com/news-releases/redhill-announces-new-uspto-patent-covering-talicia-through-2034-302085225.html
SOURCE RedHill Biopharma Ltd.