TEL-AVIV, Israel and
RALEIGH, N.C., July 20, 2021 /PRNewswire/ -- RedHill
Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a
specialty biopharmaceutical company, today announced that OptumRx,
part of the UnitedHealth Group - a leader in healthcare coverage,
partnered with more than 1.3 million healthcare professionals and
6,500 hospitals, has added Talicia® (omeprazole
magnesium, amoxicillin and rifabutin)[1] to its Commercial
Formulary as an unrestricted brand for H. pylori treatment,
effective July 1, 2021.
"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
|
[1] Talicia® (omeprazole magnesium, amoxicillin and
rifabutin) delayed-release capsules 10 mg/250 mg/12.5 mg is
indicated for the treatment of Helicobacter pylori (H.
pylori) infection in adults. For full prescribing information
see: www.Talicia.com.
[2] 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.
[3] 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).
[4] Hooi JKY et al. Global Prevalence of Helicobacter
pylori Infection: Systematic Review and Meta-Analysis.
Gastroenterology 2017; 153:420-429.
[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] Malfertheiner P. et al. Management of Helicobacter
pylori infection - the Maastricht IV/ Florence Consensus
Report, Gut 2012;61:646-664; O'Connor A. et al. Treatment
of Helicobacter pylori Infection 2015,
Helicobacter 20 (S1) 54-61; Venerito M. et al. Meta-analysis of
bismuth quadruple therapy versus clarithromycin triple therapy for
empiric primary treatment of Helicobacter
pylori infection. Digestion 2013;88(1):33-45.
[11] Full prescribing information for Movantik®
(naloxegol) is available at: www.Movantik.com.
[12] Full prescribing information for Talicia®
(omeprazole magnesium, amoxicillin and rifabutin) is available at:
www.Talicia.com.
[13] Full prescribing information for Aemcolo®
(rifamycin) is available at: www.Aemcolo.com.
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SOURCE RedHill Biopharma Ltd.