The U.S. FDA has granted five years' market
exclusivity for Talicia under the Generating Antibiotic Incentives
Now (GAIN) Act Qualified Infectious Disease Product (QIDP)
designation, as recommended by the FDA Exclusivity Board
This grant is on top of three years'
exclusivity granted for the approval of Talicia under section
505(b)(2). Talicia is protected by its broad intellectual property
suite to 2034
Talicia is the leading branded first-line
therapy prescribed by U.S.
gastroenterologists1 for
eradication of H. pylori - a bacterial infection that affects
approximately 35% of the U.S. adult
population2
RALEIGH,
N.C. and TEL-AVIV,
Israel, Nov. 27, 2023 /PRNewswire/ -- RedHill
Biopharma Ltd. (NASDAQ: RDHL) ("RedHill" or the "Company"), a
specialty biopharmaceutical company, announced that the U.S. FDA
(U.S. Food and Drug Administration) has granted five years' market
exclusivity for Talicia3 under the Generating Antibiotic
Incentives Now (GAIN) Act Qualified Infectious Disease Product
(QIDP) designation, as recommended by the FDA Exclusivity Board.
This grant is on top of three years' exclusivity granted for the
approval of Talicia under section 505(b)(2). Talicia is protected
by its broad intellectual property suite to 2034.
"Talicia is the only FDA-approved rifabutin-based therapy for
the eradication of H. pylori. Its components and formulation
are optimized to provide patients with the necessary medications
for successful H. pylori eradication, an innovation
rewarded by this market exclusivity and other IP, providing
protection to 2034," said Patricia
Anderson, RedHill's Senior Vice President of Regulatory
Affairs. "With significant concerns around maintaining
effective therapeutic options for infectious diseases in the face
of growing microbial resistance, it is vital that the most
effective options are utilized first line. Talicia's favorable
efficacy, tolerability, and resistance profile, in the only
all-in-one formulation available, provides potential advantages
over clarithromycin-based regimens for most patients."
The FDA recently approved a supplemental new drug application
(sNDA) for Talicia, allowing a change to a more flexible three
times daily (TID), taken at least 4 hours apart with food, dosing
regimen for H. pylori eradication enabling patients to
follow a convenient "breakfast, lunch and dinner" dosing routine,
which may support increased patient adherence and optimize the
potential for successful H. pylori eradication.
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
annually4. 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 cancer5 and a major
risk factor for peptic ulcer
disease6 and gastric mucosa-associated
lymphoid tissue (MALT) lymphoma7. More than
27,000 Americans are diagnosed with gastric cancer
annually8. 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 therapies2.
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 adherent9 to
their therapy had response rates of 90.3% in the Talicia arm vs.
64.7% in the active comparator arm10. 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 adults3, and
Aemcolo®, for the treatment of travelers'
diarrhea in adults11. 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
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
|
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Category: Commercial
1 IQVIA XPO Data on file
2 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 IQVIA Custom Study for RedHill Biopharma, 2019
5 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.
6 NIH – Helicobacter pylori and Cancer,
September 2013.
7 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.
8 National Cancer Institute, Surveillance,
Epidemiology, and End Results Program (SEER).
9 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.
10 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).
11 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.