RedHill and Kukbo
Enter Oral Opaganib License for COVID-19 in South
Korea
RedHill to receive $1.5 million
upfront and is eligible for up to $5.6 million in milestone
payments in addition to royalties on net sales from
Kukbo
--
Opaganib's Phase 2/3 clinical data
shows improved viral RNA clearance, reduced mortality on top of
remdesivir & corticosteroids and faster time to recovery for
moderate to severe hospitalized COVID-19 patients treated with
opaganib; potent in vitro inhibition of multiple variants also
demonstrated
TEL-AVIV, Israel, and RALEIGH,
N.C. March 15, 2022 -- InvestorsHub NewsWire
-- 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