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RNS Number : 3041U
Hutchison China Meditech Limited
28 July 2020
Chi-Med and Lilly to Collaborate in Commercializing Elunate (R)
in China
Hong Kong, Shanghai, & Florham Park, NJ: Tuesday, July 28,
2020: Hutchison China MediTech Limited ("Chi-Med") (Nasdaq/AIM:
HCM) and Eli Lilly and Company ("Lilly") today announce an
amendment to the 2013 License and Collaboration Agreement on
Fruquintinib with Lilly Shanghai, an affiliate of Lilly. The 2020
Amendment covers the expansion of Chi-Med's role in the
commercialization of Elunate(R) (fruquintinib capsules) in
China.
Under the terms of the 2020 Amendment, Lilly will maintain the
exclusive commercialization rights, and as a consequence, will
continue to consolidate the sales of Elunate(R) in China. Chi-Med
will collaborate with Lilly in commercializing Elunate(R) across
China.
In a joint statement, Mr. Christian Hogg, CEO of Chi-Med and Mr.
Julio Gay-Ger, President & General Manager, Lilly China, said
"After many years of constructive and successful collaboration,
Lilly and Chi-Med believe that this agreement now establishes the
optimal structure that will allow us to leverage the full resources
of both companies to maximize the potential of Elunate(R) in
China."
Starting October 1, 2020, Chi-Med will be responsible, through
its commercial team in oncology of over 320 staff, for the
development and execution of all on-the-ground medical detailing,
promotion and local and regional marketing activities in China for
Elunate(R) . Lilly and Chi-Med will continue to collaborate, as
before, in the formulation and execution of national marketing
strategy and events in China for Elunate(R) .
Chi-Med and Lilly will share gross profits linked to sales
target performance. Subject to meeting pre-agreed sales targets,
Lilly will pay Chi-Med an estimated total of 70% to 80% of
Elunate(R) sales in the form of royalties, manufacturing costs and
service payments. There is no upfront payment by Lilly or Chi-Med
relating to this amendment.
About Fruquintinib
Fruquintinib is a highly selective and potent oral inhibitor of
vascular endothelial growth factor receptor ("VEGFR") 1/2/3. VEGFR
inhibitors play a pivotal role in blocking tumor angiogenesis.
Fruquintinib was designed to improve kinase selectivity to minimize
off-target toxicities, improve tolerability and provide more
consistent target coverage. The generally good tolerability in
patients to date, along with fruquintinib's low potential for
drug-drug interaction based on preclinical assessment, suggests
that it may also be highly suitable for combinations with other
anti-cancer therapies.
Chi-Med retains all rights to fruquintinib outside of China and
is partnered with Lilly in China.
About fruquintinib in metastatic colorectal cancer ("mCRC")
Fruquintinib was approved for marketing by the China National
Medical Products Administration ("NMPA") in September 2018 and
commercially launched by Lilly in late November 2018 under the
brand name Elunate(R) . Elunate(R) is for the treatment of patients
with mCRC that have been previously treated with fluoropyrimidine,
oxaliplatin and irinotecan, including those who have previously
received anti-VEGF therapy and/or anti-epidermal growth factor
receptor ("EGFR") therapy (RAS wild type). Results of the FRESCO
study, a Phase III pivotal registration trial of fruquintinib in
416 patients with mCRC in China demonstrating improvement in
overall survival, were published in The Journal of the American
Medical Association, JAMA, in June 2018 (clinicaltrials.gov
identifier: NCT02314819).
In December 2017, Chi-Med initiated a Phase Ib clinical study to
evaluate fruquintinib in U.S. patients with advanced solid tumors.
Proof-of-concept cohorts in patients with mCRC and metastatic
breast cancer were added in 2019 (clinicaltrials.gov identifier:
NCT03251378).
Chi-Med is initiating FRESCO-2, a randomized, double-blind,
placebo-controlled, multicenter Phase III registration trial in
refractory mCRC in the U.S., Europe and Japan. The primary endpoint
of the study is overall survival. Over 500 patients will be
enrolled from approximately 130 sites in 10 countries. The U.S.
Food and Drug Administration (FDA) granted Fast Track Designation
for development for mCRC patients in June 2020. The FRESCO-2 study
design was also reviewed and endorsed by the European Medicines
Agency (EMA) and Japanese Pharmaceuticals and Medical Devices
Agency (PMDA) (clinicaltrials.gov identifier: NCT04322539).
Other Fruquintinib Development
Gastric Cancer in China : In October 2017, Chi-Med initiated the
FRUTIGA study, a randomized, double-blind, Phase III trial
evaluating the efficacy and safety of fru quintinib combined with
paclitaxel for second-line treatment of advanced g astric or GEJ a
denocarcinoma. The trial is designed to enroll patients who did not
respond to first-line standard chemotherapy. Subjects will receive
either fruquintinib combined with paclitaxel or placebo combined
with paclitaxel. The primary efficacy endpoint is overall survival.
In June 2020, Chi-Med completed a planned interim data review.
Based on the preset criteria, the Independent Data Monitoring
Committee (IDMC) recommended that the trial continue
(clinicaltrials.gov identifier: NCT03223376).
Immunotherapy combinations: Chi-Med has entered into three
collaboration agreements to evaluate the safety, tolerability and
efficacy of fruquintinib in combination with programmed death-1
(PD-1) monoclonal antibodies, including with tislelizumab
(BGB-A317), Tyvyt (R) (sintilimab, IBI308) and geptanolimab (GB226,
genolimzumab).
About Chi-Med
Chi-Med (Nasdaq/AIM: HCM) is an innovative, commercial-stage,
biopharmaceutical company committed, over the past twenty years, to
the discovery and global development of targeted therapies and
immunotherapies for the treatment of cancer and immunological
diseases. It has a portfolio of nine cancer drug candidates
currently in clinical studies around the world and extensive
commercial infrastructure in its home market of China. For more
information, please visit: www.chi-med.com.
About Lilly
Lilly is a global healthcare leader that unites caring with
discovery to create medicines that make life better for people
around the world. We were founded more than a century ago by a man
committed to creating high-quality medicines that meet real needs,
and today we remain true to that mission in all our work. Across
the globe, Lilly employees work to discover and bring life-changing
medicines to those who need them, improve the understanding and
management of disease, and give back to communities through
philanthropy and volunteerism. To learn more about Lilly, please
visit us at www.lilly.com.
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 Chi-Med's current expectations regarding future
events, including its expectations regarding its collaboration with
Lilly and their ability to maximize the commercial potential of
Elunate (R) in China under the terms of the above mentioned
amendment. Forward-looking statements involve risks and
uncertainties. Such risks and uncertainties include, among other
things, assumptions regarding Chi-Med's ability to successfully
assume the medical detailing, promotion and local and regional
marketing activities for Elunate (R) in China, that no unidentified
side effects will occur which could result in the NMPA pulling
fruquintinib from the market, the sufficiency of funding to support
the commercialization and further clinical development of
fruquintinib in CRC and other indications, and the impact of the
COVID-19 pandemic on general economic, regulatory and political
conditions. 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 Chi-Med's filings with the U.S. Securities and
Exchange Commission and on AIM. Chi-Med 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.
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@troutgroup.com
Europe - Ben Atwell / Alex Shaw, FTI Consulting +44 20 3727 1030 / +44 7771 913 902 (Mobile) / +44 7779
545 055 (Mobile)
Chi-Med@fticonsulting.com
Asia - Joseph Chi Lo / Zhou Yi, Brunswick +852 9850 5033 (Mobile), jlo@brunswickgroup.com / +852 97
83 6894 (Mobile), y zhou@brunswickgroup.com
Nominated Advisor
Freddy Crossley / Atholl Tweedie, Panmure Gordon (UK)
Limited +44 (20) 7886 2500
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END
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