- Hyloris will pay RedHill an upfront payment and up to
$60 million in potential milestone
payments, plus up to mid-20s percent royalties on revenues, in
return for exclusive rights to develop and commercialize RHB-102
(Bekinda®) across all indications and territories
outside the United States,
Canada and Mexico
- Recent positive UK MHRA advice provided a
clear pathway for a UK Marketing Authorization Application (MAA).
If approved, RHB-102 could be the first oral 24-hour
extended-release ondansetron for the treatment of
chemotherapy/radiotherapy-induced nausea and vomiting
(CINV/RINV)
- RedHill
intends to continue development of RHB-102 for FDA approval in the
U.S., if granted. Hyloris will be responsible for all development,
regulatory and commercialization activities related to RHB-102 in
its territories
- The global antiemetics drugs market size was
valued at approximately $7.5 billion
in 2023 and is expected to grow at a CAGR of approximately 6% from
2024 to 2030
- Positive results from the successful U.S.
Phase 2 IBS-D study (RHB-102 12 mg) and Phase 3 GUARD
gastroenteritis study (RHB-102 24 mg) were published in The
American Journal of Gastroenterology and JAMA Network Open,
respectively
TEL
AVIV, Israel and RALEIGH,
N.C., Feb. 25, 2025 /PRNewswire/ -- RedHill
Biopharma Ltd. (NASDAQ: RDHL) ("RedHill" or the "Company"), a specialty
biopharmaceutical company, today announced that it has entered into
an exclusive worldwide development and commercialization licensing
agreement, excluding North America
(the "Agreement"), with Hyloris Pharmaceuticals SA (Euronext
Brussels: HYL) ("Hyloris") for RedHill's RHB-102 (Bekinda®).
Under the terms of the Agreement, Hyloris will pay RedHill an upfront payment, in addition to up
to $60 million in potential milestone
payments, contingent upon achieving specified commercial targets,
plus up to mid-20s percent royalties on revenues, subject to
certain cost recoupments, with minimum annual payments to
RedHill, in return for exclusive
rights to RHB-102 across all indications and territories outside
the United States, Canada and Mexico. RedHill intends to continue development of
RHB-102 for FDA approval in the U.S., if granted. Hyloris will be
responsible for all development, regulatory and commercialization
activities related to RHB-102 in its territories.
RHB-102 is a once-daily, proprietary, bimodal extended-release
oral tablet formulation of ondansetron, a 5-HT3 antagonist in
advanced development for oncology support, acute gastroenteritis
and gastritis[1], and diarrhea-predominant irritable
bowel syndrome (IBS-D) at two dose strengths: 12mg and 24mg.
"Ondansetron ER will be a valuable addition to supportive care
in oncology and post-surgical settings, where sustained relief from
nausea is essential," said Thomas
Jacobsen, Co-Chief Executive Officer of Hyloris. "We are
committed to delivering innovative solutions that enhance patient
comfort and streamline therapy, especially in areas where reducing
treatment burden can make a meaningful impact. We look forward to
collaborating with RedHill to
bring this product to patients."
"Our new partners at Hyloris share our vision of RHB-102's
significant potential, and we look forward to working with them to
bring RHB-102 to patients worldwide," said Dror Ben-Asher, CEO of RedHill. "This agreement follows the
recent initiation of the Bayer-funded Phase 2 study of opaganib and
darolutamide in advanced prostate cancer and is further
demonstration of the potential of RedHill's R&D pipeline. If approved,
RHB-102 will provide the opportunity to deliver 24-hour relief from
nausea and vomiting in a single pill for outpatient use by cancer
patients undergoing chemotherapy or radiotherapy, and those with
acute gastroenteritis, gastritis or IBS-D."
Recent positive advice from the UK's Medicines and Healthcare
products Regulatory Agency (MHRA) provided a clear pathway for a UK
Marketing Authorization Application (MAA) for RHB-102 (24 mg) for
oncology support (CINV and RINV) in the UK, and potentially in
other countries, subject to completion of certain manufacturing
activities. If approved, RHB-102 could be the first oral 24-hour
extended-release ondansetron antiemetic drug for the treatment of
chemotherapy/radiotherapy-induced nausea and vomiting
(CINV/RINV).
The global antiemetics drugs market size was valued at
approximately $7.5 billion in
2023 and is expected to grow at a CAGR of approximately 6%
from 2024 to 2030[2].
RedHill have successfully
completed a U.S. Phase 3 study with RHB-102 for acute
gastroenteritis & gastritis (24 mg) and a U.S. Phase 2 study
for IBS-D (12 mg), both meeting their primary endpoints. There is
also additional potential for use in post-operative nausea and
vomiting (PONV).
About RHB-102 (Bekinda®):
RHB-102 is a proprietary, once-daily, bimodal
extended-release, oral tablet formulation of ondansetron, a 5-HT3
antagonist, targeting oncology support, acute gastroenteritis and
gastritis, and IBS-D at two dose strengths: 12mg and 24mg.
Positive results from the successful U.S. Phase 2 IBS-D study
(RHB-102 12 mg) and Phase 3 GUARD gastroenteritis study (RHB-102 24
mg) were published in The American Journal of
Gastroenterology[3] and JAMA Network
Open[4], respectively.
About Hyloris Pharmaceuticals SA
Hyloris (EBR: HYL) is a specialty biopharma company focused on
innovating, reinventing, and optimizing existing medications to
address important healthcare needs and deliver relevant
improvements for patients, healthcare professionals and payors.
Hyloris is based in Liège, Belgium. For more information, visit
www.hyloris.com or LinkedIn.
About RedHill Biopharma
RedHill Biopharma Ltd. (Nasdaq: RDHL) is a specialty
biopharmaceutical company primarily focused
on U.S. development and commercialization of drugs for
gastrointestinal diseases, infectious diseases and
oncology. RedHill promotes the gastrointestinal
drug Talicia®, for the treatment
of Helicobacter pylori (H. pylori) infection in
adults[5]. RedHill's key clinical
late-stage development programs include: (i) opaganib
(ABC294640), a first-in-class, orally
administered sphingosine kinase-2 (SPHK2) selective
inhibitor with anticancer, anti-inflammatory and antiviral
activity, targeting multiple indications with U.S. government
and academic collaborations for development for radiation and
chemical exposure indications such as GI-Acute Radiation Syndrome
(GI-ARS), a Phase 2/3 program for hospitalized COVID-19, and a
Phase 2 program study in prostate cancer in combination with
Bayer's darolutamide;
(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 / X.com/RedHillBio.
Forward-Looking Statements
This press release contains "forward-looking statements"
within the meaning of the Private Securities Litigation Reform Act
of 1995 and may discuss investment opportunities, stock analysis,
financial performance, investor relations, and market trends. 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, among others, statements regarding the potential
arrangement and relationship with Hyloris. 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 the Company will not benefit from the agreement with Hyloris
as currently anticipated; the Company's ability to maintain
compliance with the Nasdaq Capital Market's listing requirements;
the risk that the addition of new revenue generating products or
out-licensing transactions will not occur; the risk of current
uncertainty regarding U.S. government research and development
funding and that the U.S. government is under no obligation to
continue to support development of our products and can cease such
support at any time; the risk that acceptance onto the RNCP Product
Development Pipeline or other governmental and non-governmental
development programs will not guarantee ongoing development or that
any such development will not be completed or successful; the risk
that the FDA does not agree with the Company's proposed development
plans for its programs; the risk that observations from preclinical
studies are not indicative or predictive of results in clinical
trials; the risk that the Company's development programs and
studies may not be successful and, even if successful, such studies
and results may not be sufficient for regulatory applications,
including emergency use or marketing applications, and that
additional studies may be required; the risk of market and other
conditions and that the Company will not successfully commercialize
its products; 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 any necessary commercial companion
diagnostics; (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®; (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 April 8, 2024. 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
Category: Corporate
[1] Acute gastroenteritis and gastritis are
characterized by inflammation of the mucus membranes of the
gastrointestinal tract, most commonly caused by viral infection,
with symptoms including nausea, vomiting, diarrhea and abdominal
pain.
[2] Antiemetics Drugs Market Size & Share Analysis
Report 2030, Grandview research.
[3] Plasse TF, Barton G, Davidson E, et al. Bimodal
release ondansetron improves stool consistency and symptomatology
in diarrhea-predominant irritable bowel syndrome: A randomized,
double-blind trial. Am J Gastroenterol 2020;115:1466-73.
[4] Silverman RA, House SL, Meltzer AC, et al. Bimodal
Release Ondansetron for Acute Gastroenteritis Among Adolescents and
Adults: A Randomized Clinical Trial. JAMA Netw Open.
2019;2(11):e1914988. doi:10.1001/jamanetworkopen.2019.14988
[5] 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.
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