DARMSTADT, Germany - Monday, 04. December 2023
Pimicotinib (ABSK021) is currently in a global Phase III study in tenosynovial giant cell tumor (TGCT)
Merck to receive an exclusive commercial license in mainland China, Hong Kong, Macau and Taiwan with option for rest of world
Pimicotinib
has been granted Breakthrough Therapy Designation by China NMPA and
U.S. FDA and PRIME Designation by the EMA for treatment of TGCT
Not intended for UK-, US- or Canada-based media
(BUSINESS
WIRE) -- Merck, a leading science and technology company, today
announced a license agreement with Abbisko Therapeutics Co. Ltd.,
Shanghai, China, for pimicotinib (ABSK021), which is currently being
evaluated in a Phase III study for the treatment of tenosynovial giant
cell tumor (TGCT). TGCT is a benign tumor of the joints that can cause
swelling, pain, stiffness, and limited mobility of the affected joints.
Treatment options for this disease, which can seriously affect patients’
quality of life, are very limited. The agreement grants Merck a license
to commercialize pimicotinib in mainland China, Hong Kong, Macau and
Taiwan, with an option for rest of world.
“We have the
opportunity through our partnership with Abbisko to deliver a
first-in-class treatment for a critically underserved patient population
in China and potentially beyond,” said Andrew Paterson, Chief Marketing
Officer for the Healthcare business sector of Merck. “Pimicotinib
provides an opportunity to address a significant unmet medical need and
for us to expand our commercial footprint in oncology in China, the
second-largest pharmaceutical market in the world.”
Pimicotinib
is an orally administered, highly selective and potent small-molecule
antagonist of colony stimulating factor-1 receptor (CSF-1R) currently
being evaluated in a global Phase III clinical trial as a potential
therapy for TGCT. No drugs are currently approved in China for the
disease, and only one medicine has been approved in the U.S.
In a
recent Phase Ib trial, pimicotinib demonstrated clinically meaningful
and sustained antitumor activity, with an overall response rate at
one-year follow-up of 87.5% (28/32, including 3 complete responses)
among patients receiving the 50mg QD dose, as determined by the
Independent Review Committee, based on Response Evaluation Criteria in
Solid Tumors v1.1 (RECIST 1.1). The ongoing randomized, double-blind,
placebo-controlled Phase III MANEUVER trial is evaluating the efficacy
and safety of pimicotinib 50 mg QD in patients with unresectable TGCT.
“The
collaboration with Merck is an important milestone in advancing the
global commercialization process of pimicotinib, and provides a new
model for the commercialization path of Abbisko’s pipeline in the
future,” said Dr. Xu Yao-chang, Chairman of Abbisko Therapeutics. “We
are pleased to collaborate with a leading multinational pharmaceutical
company, jointly accelerating the global approval and commercialization
pace of pimicotinib, and striving to bring new treatment options to
patients as soon as possible.”
Under the terms of the agreement,
Merck will receive an exclusive license to commercialize pimicotinib in
mainland China, Hong Kong, Macau and Taiwan, with an exclusive
commercialization option in the rest of the world. Abbisko will continue
to develop pimicotinib. In addition, Merck has the option to co-develop
pimicotinib in additional indications under certain conditions. Merck
will provide Abbisko with an upfront payment of $70 million and upon
exercising the option, will provide Abbisko an option fee. Abbisko will
receive additional payments for the achievement of certain regulatory
and commercial milestones as well as double-digit tiered royalties on
net sales by Merck.
About Pimicotinib (ABSK021)
Pimicotinib
(ABSK021), which was independently developed by Abbisko Therapeutics,
is a novel, orally administered, highly selective and potent
small-molecule inhibitor of CSF-1R. Pimicotinib has been granted
breakthrough therapy designations (BTD) by China National Medical
Products Administration (NMPA) and the U.S. Food and Drug Administration
(FDA) and priority medicine (PRIME) designation from the European
Medicines Agency (EMA) for the treatment of patients with TGCT that are
not amenable to surgery.
A Phase Ia dose escalation study for
pimicotinib has been completed in the U.S., and the global Phase III
MANEUVER clinical trial of pimicotinib for the treatment of TGCT is
underway in China, the U.S., Canada, and Europe.
In addition to
TGCT, Abbisko Therapeutics is actively exploring the potential of
pimicotinib in treating other indications including many types of solid
tumors. Abbisko also has obtained approval from NMPA to conduct Phase II
clinical studies in chronic graft-versus-host disease and advanced
pancreatic cancer.
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About Merck
Merck,
a leading science and technology company, operates across life science,
healthcare and electronics. More than 64,000 employees work to make a
positive difference to millions of people’s lives every day by creating
more joyful and sustainable ways to live. From providing products and
services that accelerate drug development and manufacturing as well as
discovering unique ways to treat the most challenging diseases to
enabling the intelligence of devices – the company is everywhere. In
2022, Merck generated sales of € 22.2 billion in 66 countries.
Scientific
exploration and responsible entrepreneurship have been key to Merck’s
technological and scientific advances. This is how Merck has thrived
since its founding in 1668. The founding family remains the majority
owner of the publicly listed company. Merck holds the global rights to
the Merck name and brand. The only exceptions are the United States and
Canada, where the business sectors of Merck operate as MilliporeSigma in
life science, EMD Serono in healthcare, and EMD Electronics in
electronics.
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