REG - Hutchmed China Ltd - Fruquintinib NDA Granted Priority Review by FDA

HUTCHMED (China)Announcement

26/05/2023 07:00

For best results when printing this announcement, please click on link below:
http://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20230526:nRSZ7938Aa&default-theme=true

RNS Number : 7938A  Hutchmed (China) Limited  26 May 2023

Press Release

 

Takeda and HUTCHMED Announce New Drug Application (NDA) for Fruquintinib for Treatment of Previously Treated Metastatic Colorectal Cancer

Granted Priority Review

 

- Prescription Drug User Fee Act (PDUFA) Target Action Date set for November
30, 2023 -

 

- NDA includes results from the Phase III FRESCO-2 and FRESCO clinical trials
-

 

OSAKA, Japan, CAMBRIDGE, Massachusetts, HONG KONG, SHANGHAI &, FLORHAM
PARK, New Jersey, Friday May 26, 2023 - Takeda (TSE:4502/NYSE:TAK
(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.takeda.com%2Finvestors%2F&esheet=52286207&newsitemid=20200915005224&lan=en-US&anchor=TSE%3A4502%2FNYSE%3ATAK&index=2&md5=b7076f2bbb02ad331cdf76657f8aa07f)
) and HUTCHMED (China) Limited (Nasdaq/AIM:HCM, HKEX:13) ("HUTCHMED
(http://www.hutch-med.com/) ") today announced that the U.S. Food and Drug
Administration ("FDA") has granted priority review of the New Drug Application
("NDA") 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 U.S. for previously
treated metastatic CRC. 1 (, 2 ) The Prescription Drug User Fee Act (PDUFA)
goal date assigned by the FDA for this NDA is November 30, 2023.

 

"We are confident that fruquintinib has the potential to transform the
treatment landscape for those living with previously treated metastatic
colorectal cancer, as demonstrated by its strong clinical profile," said Awny
Farajallah, M.D., head of Global Medical Affairs Oncology at Takeda. "There
are significant needs for patients with this disease in the U.S., and we
believe fruquintinib has the potential to address these needs regardless of
patients' biomarker status. We look forward to continuing conversations with
the FDA with the goal to make this therapy available to patients as soon as
possible."

 

The NDA 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 best
supportive care ("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.

 

"The clinical benefit of fruquintinib has been confirmed in multiple ways,
from global clinical studies to commercialization in China. We are pleased to
have Takeda as our partner furthering development and commercialization of
fruquintinib outside of China," said Dr. Michael Shi, Head of R&D and
Chief Medical Officer, HUTCHMED. "Today's acceptance marks a significant
advancement towards the goal of providing patients with previously treated
metastatic colorectal cancer a much-needed therapeutic option, given the
limited treatment options currently available to patients. This also supports
our ongoing vision to design and develop differentiated molecules that help
patients with high unmet needs globally."

 

Fruquintinib is currently approved in China under the brand name ELUNATE(®).
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 (https://clinicaltrials.gov/ct2/show/NCT02314819)
). 3   In March 2023, HUTCHMED and Takeda closed
(https://www.hutch-med.com/closing-of-fruquintinib-license-to-takeda-outside-china/)
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 (https://www.hutch-med.com/fresco-2-met-primary-endpoint/) , 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 (https://clinicaltrials.gov/ct2/show/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 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 (http://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 (http://www.hutch-med.com/)
or follow us on LinkedIn (https://www.linkedin.com/company/hutchmed/) .

 

Takeda Media Contacts:
Japanese Media

Jun Saito

Jun.Saito@takeda.com (mailto:Jun.Saito@takeda.com)
 

 

U.S. and International Media

Sara Noonan

Sara.Noonan@takeda.com (mailto:Sara.Noonan@takeda.com)
 

+1 (508) 566-2408

 

Emma Nash

Emma.Nash@takeda.com (mailto: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 (mailto:bmiles@soleburystrat.com)
                                                            oleburystrat (mailto:bmiles@soleburystrat.com) .com
                                                            (mailto:bmiles@soleburystrat.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
                                                            (mailto:HUTCHMED@fticonsulting.com)
 Asia - Zhou Yi, Brunswick                                  +852 9783 6894 (Mobile) / HUTCHMED@brunswickgroup.com
                                                            (mailto:HUTCHMED@brunswickgroup.com)

 Nominated Advisor
 Atholl Tweedie / Freddy Crossley / Daphne Zhang            +44 (20) 7886 2500

 Panmure Gordon

 

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 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 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. (2014) 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, 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, 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.

 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, al. Colorectal cancer statistics, 2023 [published online ahead
of print, 2023 Mar 1]. CA Cancer J Clin. 2023;10.3322/caac.21772.
doi:10.3322/caac.21772

 7  Bando H, et al. Therapeutic landscape and future direction of metastatic
colorectal cancer. Nat Rev Gastroenterol Hepatol (2023).
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. (2014). 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 Research, 20(20),
5322-5330. https://doi.org/10.1158/1078-0432.ccr-14-0332

 10  Koopman, M., et al. (2009). Deficient mismatch repair system in patients
with sporadic advanced colorectal cancer. British Journal of Cancer, 100(2),
266-273. https://doi.org/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 (mailto:rns@lseg.com)
 or visit
www.rns.com (http://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 (https://www.lseg.com/privacy-and-cookie-policy)
.   END  MSCEQLBLXELZBBF