− Takeda to Receive Exclusive Option to License Global Rights
to Olverembatinib in All Territories Outside of Mainland China,
Hong Kong, Macau, Taiwan and Russia
− Olverembatinib Has the Potential to Address Significant
Unmet Need for Patients with Chronic Myeloid Leukemia Following
Treatment with Currently Approved TKIs
− Ascentage Pharma to Advance Late-Stage Clinical Development
of Olverembatinib Prior to Potential Exercise of the Option to
License
Takeda (TSE:4502/NYSE:TAK) today announced the signing of an
option agreement with Ascentage Pharma to enter into an exclusive
license agreement for olverembatinib, an oral, potentially
best-in-class, third-generation BCR-ABL tyrosine kinase inhibitor
(TKI), which is currently in development for chronic myeloid
leukemia (CML) and other hematological cancers. If exercised, the
option would allow Takeda to license global rights to develop and
commercialize olverembatinib in all territories outside of mainland
China, Hong Kong, Macau, Taiwan and Russia.
Despite the impact TKIs have had in the treatment of patients
with CML, there remains significant unmet need for patients whose
disease is resistant or refractory to these therapies or who
develop hard-to-treat mutations following these treatments.
“Takeda has a long history of driving important treatment
advances for patients, particularly those with hematological
cancers facing treatment gaps,” said Teresa Bitetti, president of
the Global Oncology Business Unit at Takeda. “We are highly
encouraged by the promising results olverembatinib has shown in the
clinic to date and excited to have the opportunity to potentially
further develop and deliver it to patients with chronic myeloid
leukemia and other hematological cancers. This agreement aligns
with our goal to support the advancement of both internal and
external innovation to best serve patients.”
As part of the agreement, Ascentage Pharma will continue to be
solely responsible for all clinical development of olverembatinib
prior to potential exercise of the option to license.
Olverembatinib is currently approved and marketed in China for the
treatment of adult patients with TKI-resistant chronic-phase CML
(CP-CML) or accelerated-phase CML (AP-CML) harboring the T315I
mutation and in adult patients with CP-CML resistant to and/or
intolerant of first- and second-generation TKIs.
"We are thrilled to enter into this agreement with Takeda, which
would allow us to leverage the global commercial expertise of an
organization with a proven track record and global oncology
footprint to potentially broaden the impact olverembatinib could
have on patients in need around the world,” said Dr. Dajun Yang,
Chairman and CEO of Ascentage Pharma. “We have seen the impact
olverembatinib has had on patients with CML in China and look
forward to progressing development of olverembatinib in POLARIS-2,
the global registrational Phase 3 study in previously treated adult
patients with CP-CML with or without the T315I mutation.”
Under the terms of this agreement, Ascentage Pharma will receive
an option payment of $100 million upon signing of the exclusive
option to license agreement and will be eligible for an option
exercise fee and additional potential milestone and royalty
payments if Takeda exercises the option to license olverembatinib,
with the exercise of the option being subject to customary
regulatory approvals. Additionally, Ascentage Pharma will receive a
minority equity investment from Takeda.
About Olverembatinib
Olverembatinib is an oral, third-generation BCR-ABL tyrosine
kinase inhibitor (TKI). Olverembatinib is currently approved and
marketed in China for the treatment of adult patients with
TKI-resistant chronic-phase chronic myeloid leukemia (CP-CML) or
accelerated-phase CML (AP-CML) harboring the T315I mutation and in
adult patients with CP-CML resistant to and/or intolerant of first-
and second-generation TKIs. Ascentage Pharma is investigating
olverembatinib in multiple clinical studies in several types of
cancer. Olverembatinib has been granted orphan drug designation and
Fast Track designation by the U.S. Food and Drug Administration
(FDA) and orphan designation by the European Medicines Agency
(EMA).
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 diseases,
plasma-derived therapies, oncology, neuroscience 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20240614852542/en/
Media: Japanese Media Jun Saito jun.saito@takeda.com
U.S. and International Media Jennifer Anderson
jennifer.anderson@takeda.com
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