TIDMHCM
RNS Number : 8943C
Hutchmed (China) Limited
15 June 2023
Press Release
Takeda and HUTCHMED Announce Marketing Authorization Application
of Fruquintinib for Previously Treated Metastatic Colorectal Cancer
Validated by the European Medicines Agency
- Application Includes Data from Phase III FRESCO-2 and FRESCO
Clinical Trials, which Demonstrated Superiority of Fruquintinib
Plus Best Supportive Care ("BSC") vs. Placebo plus BSC for Adult
Patients with Previously Treated Metastatic Colorectal Cancer -
Osaka, Japan, Cambridge, MA, Hong Kong, Shanghai & Florham
Park, NJ - Thursday, June 15, 2023: Takeda (TSE:4502/NYSE:TAK) and
HUTCHMED (China) Limited (Nasdaq/AIM:HCM, HKEX:13) ("HUTCHMED")
today announced that the European Medicines Agency ("EMA") has
validated and accepted for regulatory review the marketing
authorization application ("MAA") for fruquintinib, a highly
selective and potent inhibitor of vascular endothelial growth
factor receptors ("VEGFR") -1, -2 and -3 for the treatment of adult
patients with previously treated metastatic colorectal cancer
("CRC"). If approved, fruquintinib will be the first and only
highly selective inhibitor of all three VEGF receptors approved in
the E.U. for previously treated metastatic CRC.[1](,[2])
"European patients with metastatic colorectal cancer have not
benefitted from a treatment advancement in over a decade," said
Awny Farajallah, M.D., head of Global Medical Affairs Oncology at
Takeda. "We are thrilled to have submitted the marketing
authorization application to the EMA, bringing us one step closer
to potentially offering this innovative therapy to patients with
advanced disease. We believe fruquintinib has the potential to
address the longstanding unmet need for patients with previously
treated metastatic colorectal cancer regardless of their biomarker
status, and we look forward to working with the regulators
throughout the process."
The MAA for fruquintinib includes results from the Phase III
FRESCO-2 trial along with data from the Phase III FRESCO trial
conducted in China. FRESCO-2 is a global Phase III multi-regional
clinical trial (MRCT) conducted in the U.S., Europe, Japan and
Australia investigating fruquintinib plus BSC vs. placebo plus BSC
in patients with previously treated metastatic CRC. The FRESCO-2
trial met its primary and key secondary endpoints, showing a
significant and clinically meaningful improvement in overall
survival ("OS") and progression-free survival ("PFS"),
respectively. Fruquintinib has been generally well tolerated in
patients to date.
"Based on fruquintinib's clinical profile to date, we are
optimistic about its potential as a choice for patients and
physicians in the E.U. who find treatment options to be limited for
previously treated metastatic colorectal cancer," said Dr. Michael
Shi, Head of R&D and Chief Medical Officer, HUTCHMED. "We
believe the EMA validation of the marketing authorization
application for fruquintinib represents an exciting initial step
toward advancing treatment for patients in Europe and look forward
to supporting Takeda as it pursues this goal."
The validation follows the acceptance by the U.S. Food and Drug
Administration ("FDA") of a new drug application ("NDA"), announced
on May 25, 2023, which was granted Priority Review and assigned
Prescription Drug User Fee Act (PDUFA) goal date of November 30,
2023. Submission of an NDA to the Japan Pharmaceuticals and Medical
Devices Agency (PMDA) is also planned in 2023. Fruquintinib is
currently approved in China under the brand name ELUNATE(R) .
Approval in China was based on the results of the FRESCO study, a
Phase III pivotal registration trial of fruquintinib in 416
patients with metastatic CRC in China, published in The Journal of
the American Medical Association, JAMA, in June 2018
(NCT02314819).[3] In March 2023, HUTCHMED and Takeda closed an
exclusive licensing agreement to further the global development,
commercialization and manufacture of fruquintinib outside of
China.
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 FRESCO-2
The FRESCO-2 study is a multi-regional clinical trial conducted
in the U.S., Europe, Japan and Australia investigating fruquintinib
plus BSC vs placebo plus BSC in patients with previously treated
metastatic CRC. As previously disclosed, the 691-patient study met
its primary endpoint of OS in patients with metastatic CRC who had
progressed on standard chemotherapy and relevant biologic agents
and who had progressed on, or were intolerant to, TAS-102 and/or
regorafenib. In addition to OS, a statistically significant
improvement in PFS, a key secondary endpoint, was observed.
Fruquintinib has been generally well tolerated in patients to date.
Summary results were initially presented at the European Society
for Medical Oncology (ESMO) Congress in September 2022. ([4])
Additional details of the study may be found at clinicaltrials.gov,
using identifier NCT04322539.
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.[5] In the U.S., it is estimated that
153,000 patients will be diagnosed with CRC and 53,000 deaths from
the disease will occur in 2023.[6] In Europe, CRC was the second
most common cancer in 2020 with approximately 520,000 new cases and
245,000 deaths. In Japan, CRC was the most common cancer with an
estimated 148,000 new cases and 60,000 deaths in 2020.(5) Although
early-stage CRC can be surgically resected, metastatic CRC remains
an area of high unmet need with poor outcomes and limited treatment
options. Some patients with metastatic CRC may benefit from
personalized therapeutic strategies based on molecular
characteristics; however, most patients have tumors that do not
harbor actionable mutations.[7](,[8],[9],[10],[11])
About Takeda
Takeda is focused on creating better health for people and a
brighter future for the world. We aim to discover and deliver
life-transforming treatments in our core therapeutic and business
areas, including gastrointestinal and inflammation, rare disease,
plasma-derived therapies, neuroscience, oncology and vaccines.
Together with our partners, we aim to improve the patient
experience and advance a new frontier of treatment options through
our dynamic and diverse pipeline. As a leading values-based,
R&D-driven biopharmaceutical company headquartered in Japan, we
are guided by our commitment to patients, our people and the
planet. Our employees in approximately 80 countries and regions are
driven by our purpose and are grounded in the values that have
defined us for more than two centuries. For more information, visit
www.takeda.com.
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 .
Takeda Media Contacts
Japanese Media
Jun Saito
Jun.Saito@takeda.com
U.S. and International Media
Sara Noonan
Sara.Noonan@takeda.com
+1 (508) 566-2408
Emma Nash
Emma.Nash@takeda.com
+1 (404) 927-9113
HUTCHMED Contacts:
Investor Enquiries
Mark Lee, Senior Vice President +852 2121 8200
Annie Cheng, Vice President +1 (973) 306 4490
Media Enquiries
Americas - Brad Miles, Solebury Strategic Communications +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 9783 6894 (Mobile) / HUTCHMED@brunswickgroup.com
Nominated Advisor
Atholl Tweedie / Freddy Crossley / Daphne Zhang, Panmure
Gordon +44 (20) 7886 2500
Takeda Important Notice
For the purposes of this notice, "press release" means this
document, any oral presentation, any question and answer session
and any written or oral material discussed or distributed by Takeda
Pharmaceutical Company Limited ("Takeda") regarding this release.
This press release (including any oral briefing and any
question-and-answer in connection with it) is not intended to, and
does not constitute, represent or form part of any offer,
invitation or solicitation of any offer to purchase, otherwise
acquire, subscribe for, exchange, sell or otherwise dispose of, any
securities or the solicitation of any vote or approval in any
jurisdiction. No shares or other securities are being offered to
the public by means of this press release. No offering of
securities shall be made in the United States except pursuant to
registration under the U.S. Securities Act of 1933, as amended, or
an exemption therefrom. This press release is being given (together
with any further information which may be provided to the
recipient) on the condition that it is for use by the recipient for
information purposes only (and
not for the evaluation of any investment, acquisition, disposal
or any other transaction). Any failure to comply with these
restrictions may constitute a violation of applicable securities
laws. The companies in which Takeda directly and indirectly owns
investments are separate entities. In this press release, "Takeda"
is sometimes used for convenience where references are made to
Takeda and its subsidiaries in general. Likewise, the words "we",
"us" and "our" are also used to refer to subsidiaries in general or
to those who work for them. These expressions are also used where
no useful purpose is served by identifying the particular company
or companies.
Takeda Forward-Looking Statements
This press release and any materials distributed in connection
with this press release may contain forward-looking statements,
beliefs or opinions regarding Takeda's future business, future
position and results of operations, including estimates, forecasts,
targets and plans for Takeda. Without limitation, forward-looking
statements often include words such as "targets", "plans",
"believes", "hopes", "continues", "expects", "aims", "intends",
"ensures", "will", "may", "should", "would", "could" "anticipates",
"estimates", "projects" or similar expressions or the negative
thereof. These forward-looking statements are based on assumptions
about many important factors, including the following, which could
cause actual results to differ materially from those expressed or
implied by the forward-looking statements: the economic
circumstances surrounding Takeda's global business, including
general economic conditions in Japan and the United States;
competitive pressures and developments; changes to applicable laws
and regulations, including global health care reforms; challenges
inherent in new product development, including uncertainty of
clinical success and decisions of regulatory authorities and the
timing thereof; uncertainty of commercial success for new and
existing products; manufacturing difficulties or delays;
fluctuations in interest and currency exchange rates; claims or
concerns regarding the safety or efficacy of marketed products or
product candidates; the impact of health crises, like the novel
coronavirus pandemic, on Takeda and its customers and suppliers,
including foreign governments in countries in which Takeda
operates, or on other facets of its business; the timing and impact
of post-merger integration efforts with acquired companies; the
ability to divest assets that are not core to Takeda's operations
and the timing of any such divestment(s); and other factors
identified in Takeda's most recent Annual Report on Form 20-F and
Takeda's other reports filed with the U.S. Securities and Exchange
Commission, available on Takeda's website at:
https://www.takeda.com/investors/sec-filings/ or at www.sec.gov.
Takeda does not undertake to update any of the forward-looking
statements contained in this press release or any other
forward-looking statements it may make, except as required by law
or stock exchange rule. Past performance is not an indicator of
future results and the results or statements of Takeda in this
press release may not be indicative of, and are not an estimate,
forecast, guarantee or projection of Takeda's future results.
HUTCHMED Forward-Looking Statements
This press release 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 a
MAA for fruquintinib for the treatment of CRC with the EMA 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 MAA approval of
fruquintinib for the treatment of patients with CRC or other
indications in the E.U. or other jurisdictions such as the U.S. 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
press release, whether as a result of new information, future
events or circumstances or otherwise.
Takeda Medical Information
This press release contains information about products that may
not be available in all countries, or may be available under
different trademarks, for different indications, in different
dosages, or in different strengths. Nothing contained herein should
be considered a solicitation, promotion or advertisement for any
prescription drugs including the ones under development.
[1] Xu X, et al. Efficacy and safety of regorafenib and
fruquintinib as third-line treatment for colorectal cancer: a
narrative review. Transl Cancer Res. 2022;11(1):276-287.
doi:10.21037/tcr-20-3539.
[2] Sun Q, et al. Discovery of fruquintinib, a potent and highly
selective small molecule inhibitor of VEGFR 1, 2, 3 tyrosine
kinases for cancer therapy, Cancer Biol Ther. 2014;15:12,
1635-1645. doi:10.4161/15384047.2014.964087.
[3] Li J, 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, 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.
doi:10.1016/annonc/annonc1089.
[5] Sung H, et al. Global Cancer Statistics 2020: GLOBOCAN
Estimates of Incidence and Mortality Worldwide for 36 Cancers in
185 Countries. CA Cancer J Clin. 2021;71(3):209-249.
doi:10.3322/caac.21660.
[6] Siegel RL, et al. Colorectal cancer statistics, 2023
[published online ahead of print, 2023 Mar 1]. CA Cancer J Clin .
2023; 73(3):233-254. doi:10.3322/caac.21772.
[7] Bando H, et al. Therapeutic landscape and future direction
of metastatic colorectal cancer. Nat Rev Gastroenterol Hepatol.
2023;20(5):306-322. doi:10.1038/s41575-022-00736-1.
[8] D'Haene N, et al. Clinical application of targeted
next-generation sequencing for colorectal cancer patients: a
multicentric Belgian experience. Oncotarget.
2018;9(29):20761-20768. Published 2018 Apr 17.
doi:10.18632/oncotarget.25099.
[9] Venderbosch, et al. Mismatch repair status and braf mutation
status in metastatic colorectal cancer patients: A pooled analysis
of the Cairo, Cairo2, coin, and Focus Studies. Clinical Cancer Res.
2014;20(20):5322-5330. doi:10.1158/1078-0432.ccr-14-0332.
[10] Koopman, M., et al. Deficient mismatch repair system in
patients with sporadic advanced colorectal cancer. Br J Cancer.
2009;100(2):266-273. doi:10.1038/sj.bjc.6604867.
[11] Ahcene Djaballah S, et al. HER2 in Colorectal Cancer: The
Long and Winding Road From Negative Predictive Factor to Positive
Actionable Target. Am Soc Clin Oncol Educ Book. 2022;42:1-14.
doi:10.1200/EDBK_351354.
This information is provided by RNS, the news service of the
London Stock Exchange. RNS is approved by the Financial Conduct
Authority to act as a Primary Information Provider in the United
Kingdom. Terms and conditions relating to the use and distribution
of this information may apply. For further information, please
contact rns@lseg.com or visit www.rns.com.
RNS may use your IP address to confirm compliance with the terms
and conditions, to analyse how you engage with the information
contained in this communication, and to share such analysis on an
anonymised basis with others as part of our commercial services.
For further information about how RNS and the London Stock Exchange
use the personal data you provide us, please see our Privacy
Policy.
END
MSCGPUCGQUPWGCA
(END) Dow Jones Newswires
June 15, 2023 10:39 ET (14:39 GMT)
Hutchison China Meditech (LSE:0J7G)
Historical Stock Chart
From Oct 2024 to Nov 2024
Hutchison China Meditech (LSE:0J7G)
Historical Stock Chart
From Nov 2023 to Nov 2024
