"Momentum
with Talicia is growing strongly
and the addition of
unrestricted Commercial
coverage for Talicia
by OptumRx,
a major
operator in U.S. healthcare coverage serving
more than
26 million
Americans, is an
important advance in extending patient access to Talicia,
which now extends
to greater
than
8 out of
10 covered
U.S.
Commercial
lives,"
said
Rick Scruggs, RedHill's Chief Commercial Officer.
"Talicia
is the first and only FDA-approved rifabutin-based therapy for the
treatment of H.
pylori infection, and
this listing
represents the understanding within the medical community of the
need to combat the high and growing resistance of
H.
pylori to commonly
used antibiotics with an effective
new first-line
treatment."
About
Talicia®
Talicia®
is the only
rifabutin-based therapy approved for the treatment of
H.
pylori infection and is
designed to address the high resistance of H.
pylori bacteria to
clarithromycin-based therapies. 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 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[2]
to
their therapy had response rates of 90.3% in the
Talicia®
arm
vs. 64.7% in the active comparator arm[3].
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.
About H.
pylori
H. pylori
is a bacterial
infection
that
affects approximately 35%[4]
of the U.S. population, with an estimated two million patients
treated annually[5].
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[6]
and a major risk factor for peptic ulcer disease[7] and
gastric mucosa-associated lymphoid tissue (MALT)
lymphoma[8].
More than 27,000 Americans
are diagnosed with gastric cancer annually[9].
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 commonly used in standard combination
therapies[10].
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, Movantik®
for opioid-induced
constipation in adults[11],
Talicia®
for the treatment
of Helicobacter
pylori (H. pylori) infection in
adults[12], and
Aemcolo®
for the treatment of
travelers' diarrhea in adults[13]. RedHill's key
clinical late-stage development programs include: (i)
RHB-204,
with an ongoing Phase
3 study for pulmonary nontuberculous mycobacteria (NTM) disease;
(ii) opaganib
(ABC294640), a
first-in-class SK2
selective inhibitor targeting multiple indications with
positive Phase 2
COVID-19 data and an
ongoing Phase 2/3 program for
COVID-19 and Phase 2 studies for prostate cancer and
cholangiocarcinoma ongoing; (iii) RHB-107
(upamostat), a serine
protease inhibitor
in a
U.S.
Phase 2/3
study as treatment
for symptomatic
COVID-19, and
targeting multiple other cancer and inflammatory gastrointestinal
diseases; (iv) RHB-104, with positive
results from a first Phase 3 study for Crohn's disease; (v)
RHB-102
(Bekinda®), with positive
results from a Phase 3 study for acute gastroenteritis and
gastritis and positive results from a Phase 2 study for IBS-D; and
(vi) RHB-106, an
encapsulated bowel preparation. More information about the Company
is available at
www.redhillbio.com /
https://twitter.com/RedHillBio.
About
OptumRx
OptumRx provides a full spectrum of pharmacy care services through
its network of more than 67,000 retail
pharmacies, multiple home delivery,
specialty
and community health pharmacies and through the provision of
in-home and pharmacy infusion services. OptumRx manages limited and
ultra-limited distribution drugs in
oncology, HIV, pain management and ophthalmology and serves the
growing pharmacy needs of people with
behavioral health and substance use disorders, particularly
Medicare and Medicaid beneficiaries.
OptumRx's comprehensive whole-person approach to pharmacy care
services integrates demographic, medical,
laboratory, pharmaceutical and other clinical data and applies
analytics to drive clinical care insight to support
care treatments and compliance, benefiting clients and individual
consumers through enhanced services, elevated
clinical
quality
and cost trend management.
About
Talicia® (omeprazole
magnesium, amoxicillin and rifabutin)
INDICATION
AND USAGE
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.
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.
Acute Interstitial
Nephritis has been observed in patients taking PPIs and
penicillins.
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
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 include,
without limitation, the
risk
that Company
will be unable to secure additional Pharmacy
Benefit
Management
formulary
coverage for Talicia®,
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®
and Movantik®;
(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
March
18,
2021.
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
Media
contacts:
U.S.:
Bryan Gibbs,
Finn
Partners
+1 212 529
2236
bryan.gibbs@finnpartners.com
UK:
Amber Fennell,
Consilium
+44 (0) 7739 658
783
fennell@consilium-comms.com