TEL-AVIV, Israel, and
RALEIGH, N.C.,
March 15, 2022
/PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL)
("RedHill" or the "Company"), a specialty biopharmaceutical
company, announced that it has entered into an exclusive license
agreement with Kukbo Co. Ltd. (Kospi: 001140) ("Kukbo"), a South
Korean corporation, for oral opaganib[1] for the
treatment of COVID-19, in South
Korea.
Under the terms of the license agreement, which follows the
previously announced strategic investment by Kukbo, RedHill will
receive an upfront payment of $1.5
million and is eligible for up to $5.6 million in milestone payments as well as low
double-digit royalties on net sales of oral opaganib in
South Korea. Kukbo will receive
the exclusive rights to commercialize opaganib in South Korea for COVID-19.
Dror Ben-Asher, RedHill's CEO,
said: "South Korea is
currently experiencing a spike in COVID-19 cases with the Korea
Disease Control & Prevention Agency reporting almost 4 million
new cases already registered in the first half of March alone.
Together with our partner, Kukbo, we are working hard to bring
opaganib to Korean patients in need of new COVID-19 therapeutic
options."
"Every day this month we are seeing an average of almost 2000
people hospitalized due to COVID-19 in South Korea and we desperately need
medications that can effectively treat these patients," said
Hyun Ha, Kukbo's CEO. "With the
data supporting opaganib for COVID-19, and the expanded partnership
with RedHill, Kukbo is determined to work with local regulators
with the aim of bringing opaganib to South Korean patients, as soon
as possible."
The partnership with Kukbo also includes a right of first offer
for RedHill's late-stage clinical assets, opaganib, RHB-107
(upamostat)[2] and Talicia®, for one or
more of the territories of South
Korea, Japan, Indonesia, Vietnam, Thailand and/or Malaysia. The right of first offer has been
extended as part of the new license agreement until the end of
October 2022.
About Opaganib (ABC294640)
Opaganib, a new chemical
entity, is a proprietary, first-in-class, orally-administered,
sphingosine kinase-2 (SK2) selective inhibitor, with proposed dual
anti-inflammatory and antiviral activity. Opaganib is host-targeted
and is expected to be effective against emerging viral variants,
having already demonstrated inhibition against variants of concern,
including Delta. Opaganib has also shown anticancer activity
and positive preclinical results in renal fibrosis, and has the
potential to target multiple oncology, viral, inflammatory, and
gastrointestinal indications.
In prespecified analyses of Phase 2/3 clinical data, oral
opaganib has demonstrated improved viral RNA clearance, significant
mortality reduction on top of remdesivir and corticosteroids and
faster time to recovery. Opaganib previously delivered promising
U.S. Phase 2 data in patients with moderate to severe COVID-19,
submitted for peer review and recently published in medRxiv.
Opaganib has also received Orphan Drug designation from the
U.S. FDA for the treatment of cholangiocarcinoma and is being
evaluated in a Phase 2a study in advanced cholangiocarcinoma and in
a Phase 2 study in prostate cancer. Patient accrual, treatment and
analysis in this study are ongoing.
Opaganib demonstrated potent antiviral activity against
SARS-CoV-2, the virus that causes COVID-19, inhibiting viral
replication of the original SARS-CoV-2 and variants tested to date
in an in vitro model of human lung bronchial tissue.
Additionally, preclinical in vivo studies have demonstrated
opaganib's potential to decrease renal fibrosis, have shown
decreased fatality rates from influenza virus infection, and
amelioration of bacteria-induced pneumonia lung injury with reduced
levels of IL-6 and TNF-alpha in bronchoalveolar lavage
fluids[3].
The ongoing clinical studies with opaganib are registered
on www.ClinicalTrials.gov, a web-based service by the U.S. National
Institute of Health, which provides public access to information on
publicly and privately supported clinical studies.
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[4], Talicia® for the
treatment of Helicobacter pylori (H. pylori) infection in
adults[5], and Aemcolo® for
the treatment of travelers' diarrhea in
adults[6]. 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 oral SK2 selective inhibitor targeting
multiple indications with a Phase 2/3 program for COVID-19 and
Phase 2 studies for prostate cancer and cholangiocarcinoma ongoing;
(iii) RHB-107 (upamostat), an oral 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, 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/ 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 and include the plan for potential emergency and
marketing authorization applications in certain ex-U.S. countries
in the first half of 2022. 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 the Phase 2/3 COVID-19 study for
opaganib and its results may not be sufficient for regulatory
applications, including emergency use or marketing applications,
and that additional COVID-19 studies for opaganib are likely to be
required by regulatory authorities to support such potential
applications and the use or marketing of opaganib for COVID-19
patients, that emergency and marketing authorization applications
in certain ex-U.S. countries will be delayed, that opaganib will
not be effective against emerging viral variants, as well as risks
and uncertainties associated with (i) the initiation, timing,
progress and results of the Company's research, manufacturing,
preclinical 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 preclinical 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
Movantik®, 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 and sustain 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,
preclinical 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 commercial products 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 events 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
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. / UK:
Amber Fennell, Consilium +44
(0) 7739 658 783 fennell@consilium-comms.com
|
Category: Corporate
[1] Opaganib is an investigational new drug, not
available for commercial distribution.
[2] RHB-107 (upamostat) is an investigational new drug,
not available for commercial distribution.
[3] Xia C. et al. Transient inhibition of sphingosine
kinases confers protection to influenza A virus infected mice.
Antiviral Res. 2018 Oct; 158:171-177. Ebenezer DL et al.
Pseudomonas aeruginosa stimulates nuclear
sphingosine-1-phosphate generation and epigenetic regulation of
lung inflammatory injury. Thorax. 2019 Jun;74(6):579-591.
[4] Full prescribing information for
Movantik® (naloxegol) is available at:
www.Movantik.com.
[5] Full prescribing information for Talicia®
(omeprazole magnesium, amoxicillin and rifabutin) is available at:
www.Talicia.com.
[6] Full prescribing information for Aemcolo®
(rifamycin) is available at: www.Aemcolo.com.
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SOURCE RedHill Biopharma Ltd.