REG - Hutchmed China Ltd - License to Takeda for Fruquintinib outside China

HUTCHMED (China)Announcement

23/01/2023 08:00

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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 (https://www.hutch-med.com/) ")
(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
(https://www.hutch-med.com/fruquintinib-fresco-2-data-summary-esmo-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(®)
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(®) 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/ (https://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 
(#_edn1) In the U.S., an estimated 155,000 patients were diagnosed with CRC
and there were 54,000 deaths from the disease. 2  (#_edn2) 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(®).  It has been included in the
NRDL since January 2020.  ELUNATE(®) 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  (#_edn3) , a Phase III pivotal
registration trial of fruquintinib in 416 patients with metastatic CRC in
China, were published
(https://jamanetwork.com/journals/jama/fullarticle/2685988) in The Journal of
the American Medical Association, JAMA, in June 2018 (NCT02314819
(https://clinicaltrials.gov/ct2/show/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 (https://clinicaltrials.gov/ct2/show/NCT04322539)
). The results were presented
(https://www.hutch-med.com/fruquintinib-fresco-2-data-summary-esmo-2022/) at
ESMO in September 2022. 4  (#_edn4) 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
(https://clinicaltrials.gov/ct2/show/record/NCT03223376) ). Topline results
were reported
(https://www.hutch-med.com/fruquintinib-frutiga-gastric-cancer-topline-result/)
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
(https://www.hutch-med.com/) or follow us on LinkedIn
(https://www.linkedin.com/company/hutchmed/) .

 

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 (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, Panmure Gordon  +44 (20) 7886 2500

 

 1  (#_ednref1) The Global Cancer Observatory (https://gco.iarc.fr/) .
Accessed December 12, 2022.

 2  (#_ednref2) SEER. Cancer Stat Facts: Colorectal Cancer. National Cancer
Institute.  https://seer.cancer.gov/statfacts/html/colorect.html
(https://seer.cancer.gov/statfacts/html/colorect.html) . Accessed December 12,
2022.

 3  (#_ednref3) 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 (https://doi.org/10.1001/jama.2018.7855) .

 4  (#_ednref4) 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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