TIDMHCM
RNS Number : 5247N
Hutchmed (China) Limited
23 January 2023
HUTCHMED Announces License to Takeda to Develop and
Commercialize Fruquintinib Outside China
- HUTCHMED to receive US$400 million upfront on deal closing and
up to US$730 million in potential future milestone payments,
totaling up to US$1.13 billion, plus royalties on net sales -
- Marketing authorization submissions in the U.S., Europe and
Japan planned to complete in 2023 -
- Partnership approach aligned with HUTCHMED's path to
profitability and strategy to bring its innovative medicines to
patients worldwide -
- HUTCHMED to host a conference call and webcast at 8:30 a.m.
EST (1:30 p.m. GMT / 9:30 p.m. HKT) on Monday, January 23, 2023
-
Hong Kong, Shanghai & Florham Park, NJ - Monday, January 23,
2023: HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:HCM,
HKEX:13) today announces that its subsidiary, HUTCHMED Limited, has
entered into an exclusive license agreement with a subsidiary of
Takeda Pharmaceutical Company Limited (TSE:4502, NYSE:TAK) to
further the global development, commercialization and manufacture
of fruquintinib outside of mainland China, Hong Kong and Macau,
where it is marketed by HUTCHMED. HUTCHMED Limited will receive up
to US$1.13 billion including US$400 million upfront on closing as
well as potential regulatory, development and commercial sales
milestone payments, plus royalties on net sales.
Fruquintinib is a highly selective and potent inhibitor of
vascular endothelial growth factor receptors ("VEGFR") -1, -2 and
-3. Fruquintinib is orally administered and has the potential to be
used across subtypes of metastatic colorectal cancer ("CRC"),
regardless of biomarker status. Positive results of FRESCO-2, the
global Phase III multi-regional clinical trial of fruquintinib in
refractory metastatic colorectal cancer ("CRC"), were presented at
the European Society for Medical Oncology Congress ("ESMO") in
September 2022. FRESCO-2 met its primary endpoint of improving
overall survival ("OS") in patients with metastatic CRC and was
generally well tolerated.
"We are pleased to be partnering with a company that shares our
mission to improve treatment outcomes for cancer patients and has
the scale and expertise in global drug development and
commercialization to advance fruquintinib globally outside of
China," said Dr. Weiguo Su, Executive Director, Chief Executive
Officer and Chief Scientific Officer of HUTCHMED.
"For HUTCHMED, this transaction is consistent with our strategic
shift that we announced in November 2022 to accelerate our path to
profitability. We stated that we would focus on the innovative
medicines in our pipeline such as fruquintinib and others that are
most likely to generate near-term value, and that we would be
uncompromising in our commitment to bringing our medicines to
patients worldwide. Not only does the license with Takeda
accelerate this global ambition, but it provides us with more
bandwidth and extended cash runway to advance other opportunities.
We are very excited about the future for HUTCHMED."
"Fruquintinib has the potential to change the treatment
landscape for patients with refractory metastatic CRC who are in
need of additional treatment options. We look forward to utilizing
our development and commercial capabilities to expand the potential
of this innovative medicine to patients beyond China," said Teresa
Bitetti, President of the Global Oncology Business Unit at Takeda.
"We have a strong track record of working with companies that share
our focus on bringing transformative medicines to patients around
the globe who need them. Working with HUTCHMED will enable us to
expand our oncology portfolio, bringing us one step closer to
achieving our aspiration to cure cancer."
Under the terms of the agreement, Takeda will receive an
exclusive worldwide license to develop and commercialize
fruquintinib from HUTCHMED Limited in all indications and
territories outside of mainland China, Hong Kong and Macau. Subject
to the terms of the agreement, HUTCHMED Limited will be eligible to
receive up to US$1.13 billion, including US$400 million upfront on
closing of the agreement, and up to US$730 million in additional
potential payments relating to regulatory, development and
commercial sales milestones, as well as royalties on net sales.
The deal is subject to customary closing conditions, including
completion of antitrust regulatory reviews. Following these
clearances, Takeda will become solely responsible for the
development and commercialization of fruquintinib in all included
territories worldwide excluding mainland China, Hong Kong and
Macau. As previously announced, marketing authorization submissions
in the U.S., Europe and Japan are planned to complete in 2023, with
the rolling submission to the U.S. Food and Drug Administration
("FDA") planned to complete in the first half of 2023.
HUTCHMED will continue to focus on progressing late-stage
clinical trials and the commercialization of fruquintinib in
mainland China in collaboration with Eli Lilly and Company, where
it is approved under the brand name ELUNATE(R) for the treatment of
patients with metastatic CRC who have been previously treated with
fluoropyrimidine, oxaliplatin and irinotecan, including those who
have previously received anti-vascular endothelial growth factor
therapy and/or anti-epidermal growth factor receptor ("EGFR")
therapy (RAS wild type). ELUNATE(R) has been included in the China
National Reimbursement Drug List ("NRDL") since January 2020.
Management of HUTCHMED will host a conference call and webcast
for investors and analysts on Monday, January 23, 2023, at 8:30
a.m. New York time (1:30 p.m. London time, 9:30 p.m. Hong Kong
Time). Details of the conference call dial-in and the webcast link
will be provided on the company website at
www.hutch-med.com/event/. A replay will also be available on the
website shortly after the event.
Evercore Group LLC is acting as exclusive financial advisor to
HUTCHMED and Ropes & Gray LLP is serving as its legal
advisor.
About CRC
CRC is a cancer that starts in either the colon or rectum.
According to the International Agency for Research on Cancer, CRC
is the third most prevalent cancer worldwide, associated with more
than 935,000 deaths in 2020. [1] In the U.S., an estimated 155,000
patients were diagnosed with CRC and there were 54,000 deaths from
the disease. [2] In Europe, CRC was the second most common cancer
in 2020, with approximately 520,000 new cases and 245,000 deaths.
In Japan, CRC is the most common cancer, with an estimated 148,000
new cases and 60,000 deaths in 2020.(1) Although early stage CRC
can be surgically resected, metastatic CRC remains an area of high
unmet need with poor outcomes and limited treatment options.
About Fruquintinib
Fruquintinib is a highly selective and potent oral inhibitor of
VEGFR-1, -2 and -3. VEGFR inhibitors play a pivotal role in
blocking tumor angiogenesis. Fruquintinib was designed to improve
kinase selectivity with the intention of minimizing off-target
toxicities, improving tolerability and providing more consistent
target coverage. Fruquintinib has been generally well tolerated in
patients to date, and is being investigated in combinations with
other anti-cancer therapies.
About Fruquintinib Approval in CRC in China
Fruquintinib was approved for marketing by the China National
Medical Products Administration (NMPA) in September 2018 and
commercially launched in China in November 2018 under the brand
name ELUNATE(R) . It has been included in the NRDL since January
2020. ELUNATE(R) is indicated for the treatment of patients with
metastatic CRC who have been previously treated with
fluoropyrimidine, oxaliplatin and irinotecan, including those who
have previously received anti-VEGF therapy and/or anti-EGFR therapy
(RAS wild type). Results of the FRESCO study [3] , a Phase III
pivotal registration trial of fruquintinib in 416 patients with
metastatic CRC in China, were published in The Journal of the
American Medical Association, JAMA, in June 2018 (NCT02314819).
The safety and efficacy of fruquintinib for the following
investigational uses have not been established and there is no
guarantee that it will receive health authority approval or become
commercially available in any country for the uses being
investigated.
About the FRESCO-2 Phase III Trial in CRC Outside China
The FRESCO-2 study is a multi-regional clinical trial conducted
in the U.S., Europe, Japan and Australia that investigated
fruquintinib plus best supportive care ("BSC") vs placebo plus BSC
in patients with refractory metastatic CRC (NCT04322539 ). The
results were presented at ESMO in September 2022. [4] The MRCT
FRESCO-2 study demonstrated that treatment with fruquintinib
resulted in a statistically significant and clinically meaningful
increase in the primary OS endpoint and key secondary progression
free survival ("PFS") endpoint compared to treatment with
placebo.
Specifically, the median OS was 7.4 months for the 461 patients
treated with fruquintinib compared to 4.8 months for the 230
patients in the placebo group (hazard ratio ["HR"] 0.66; 95%
confidence interval ["CI"] 0.55-0.80; p<0.001). The median PFS
was 3.7 months for patients treated with fruquintinib compared to
1.8 months for patients in the placebo group (HR 0.32; 95% CI
0.27-0.39; p<0.001). The disease control rate ("DCR") was 55.5%
in the fruquintinib group compared to 16.1% for patients in the
placebo group. Median duration of follow-up was approximately 11
months for patients in both groups.
The safety profile of fruquintinib in FRESCO-2 was consistent
with previously reported fruquintinib studies. Grade 3 or above
adverse events occurred in 62.7% of patients who received
fruquintinib, compared to 50.4% of patients who received placebo.
Grade 3 or above adverse events that occurred in more than 5% of
patients who received fruquintinib were hypertension (13.6% vs 0.9%
in the placebo group), asthenia (7.7% vs 3.9% in the placebo group)
and hand-foot syndrome (6.4% vs 0% in the placebo group). Treatment
related adverse events leading to discontinuation occurred in 20.4%
of patients who received fruquintinib, compared to 21.1% of
patients who received placebo.
About Other Fruquintinib Developments
Gastric Cancer in China: The FRUTIGA study is a randomized,
double-blind, Phase III study in China to evaluate fruquintinib
combined with paclitaxel compared with paclitaxel monotherapy, for
second-line treatment of advanced gastric cancer or
gastroesophageal junction adenocarcinoma (NCT03223376). Topline
results were reported in November 2022. The trial met one of the
primary endpoints of statistically significant improvement in PFS,
which is clinically meaningful. The other primary endpoint of OS
was not statistically significant per the pre-specified statistical
plan, although there was a numerical improvement in median OS.
Fruquintinib also demonstrated a statistically significant
improvement in secondary endpoints including objective response
rate (ORR), DCR, and improved duration of response (DoR). The
safety profile of fruquintinib in FRUTIGA was consistent with
previously reported studies. Full detailed results are subject to
ongoing analysis and are expected to be disclosed at an upcoming
scientific meeting.
HUTCHMED is also developing fruquintinib for the treatment of
multiple solid tumor cancers in combination with PD-1 monoclonal
antibodies for the treatment of endometrial and other solid
tumors.
About HUTCHMED
HUTCHMED (Nasdaq/AIM:HCM; HKEX:13) is an innovative,
commercial-stage, biopharmaceutical company. It is committed to the
discovery and global development and commercialization of targeted
therapies and immunotherapies for the treatment of cancer and
immunological diseases. It has approximately 5,000 personnel across
all its companies, at the center of which is a team of about 1,800
in oncology/immunology. Since inception it has focused on bringing
cancer drug candidates from in-house discovery to patients around
the world, with its first three oncology drugs now approved and
marketed in China. For more information, please visit:
www.hutch--med.com or follow us on LinkedIn.
Forward-Looking Statements
This announcement contains forward-looking statements within the
meaning of the "safe harbor" provisions of the U.S. Private
Securities Litigation Reform Act of 1995. These forward-looking
statements reflect HUTCHMED's current expectations regarding future
events, including its expectations regarding the submission of an
NDA for fruquintinib for the treatment of CRC with the FDA and the
timing of such submission, the therapeutic potential of
fruquintinib for the treatment of patients with CRC and the further
clinical development of fruquintinib in this and other indications.
Forward-looking statements involve risks and uncertainties. Such
risks and uncertainties include, among other things, assumptions
regarding the timing and outcome of clinical studies and the
sufficiency of clinical data to support NDA approval of
fruquintinib for the treatment of patients with CRC or other
indications in the U.S. or other jurisdictions such as Europe or
Japan, its potential to gain approvals from regulatory authorities
on an expedited basis or at all; the efficacy and safety profile of
fruquintinib; HUTCHMED's ability to fund, implement and complete
its further clinical development and commercialization plans for
fruquintinib; the timing of these events; each party's ability to
satisfy the terms and conditions under the license agreement;
actions of regulatory agencies, which may affect the initiation,
timing and progress of clinical trials or the regulatory pathway
for fruquintinib; Takeda's ability to successfully develop and
commercialize fruquintinib; and the impact of the COVID-19 pandemic
on general economic, regulatory and political conditions. In
addition, as certain studies rely on the use of other drug products
such as paclitaxel as combination therapeutics with fruquintinib,
such risks and uncertainties include assumptions regarding the
safety, efficacy, supply and continued regulatory approval of these
therapeutics. Such forward-looking statements include, without
limitation, statements regarding the plan to develop and
commercialize fruquintinib under the license agreement; potential
payments under the license agreement, including the upfront payment
and any milestone or royalty payments; potential benefits of the
license agreement; and HUTCHMED's strategy, goals and anticipated
milestones, business plans and focus. Existing and prospective
investors are cautioned not to place undue reliance on these
forward-looking statements, which speak only as of the date hereof.
For further discussion of these and other risks, see HUTCHMED's
filings with the U.S. Securities and Exchange Commission, on AIM
and on The Stock Exchange of Hong Kong Limited. HUTCHMED undertakes
no obligation to update or revise the information contained in this
announcement, whether as a result of new information, future events
or circumstances or otherwise.
Inside Information
This announcement contains inside information for the purposes
of Article 7 of Regulation (EU) No 596/2014 (as it forms part of
retained EU law as defined in the European Union (Withdrawal) Act
2018).
HUTCHMED CONTACTS
Investor Enquiries
Mark Lee, Senior Vice President +852 2121 8200
Annie Cheng, Vice President +1 (973) 567 3786
Media Enquiries
Americas - Brad Miles, Solebury Trout +1 (917) 570 7340 (Mobile) / bmiles@s oleburystrat .com
Europe - Ben Atwell / Alex Shaw, FTI Consulting +44 20 3727 1030 / +44 7771 913 902 (Mobile) / +44 7779 545 055
(Mobile) / HUTCHMED@fticonsulting.com
Asia - Zhou Yi, Brunswick +852 97 83 6894 (Mobile) / HUTCHMED@brunswickgroup.com
Nominated Advisor
Atholl Tweedie / Freddy Crossley, Panmure Gordon +44 (20) 7886 2500
[1] The Global Cancer Observatory. Accessed December 12,
2022.
[2] SEER. Cancer Stat Facts: Colorectal Cancer. National Cancer
Institute. https://seer.cancer.gov/statfacts/html/colorect.html.
Accessed December 12, 2022.
[3] Li J, Qin S, Xu RH, et al. Effect of Fruquintinib vs Placebo
on Overall Survival in Patients With Previously Treated Metastatic
Colorectal Cancer: The FRESCO Randomized Clinical Trial. JAMA.
2018;319(24):2486-2496. doi:10.1001/jama.2018.7855.
[4] Dasari NA, Lonardi S, et al. LBA25 - FRESCO-2: A global
phase III multiregional clinical trial (MRCT) evaluating the
efficacy and safety of fruquintinib in patients with refractory
metastatic colorectal cancer. Ann Oncol. 2022 Sep;33(suppl_7):
S808-S869. 10.1016/annonc/annonc1089.
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