Japanese pharmaceutical company Takeda has signed an agreement with the US-based biopharma firm Ascentage Pharma, to obtain an exclusive global license to olverembatinib.
Under the terms of this agreement, Ascentage will receive a $100m option payment upon signing the option agreement.
If Takeda exercises the option, it will get global rights to develop and commercialise olverembatinib in all geographies outside China, Hong Kong, Macau, Taiwan, and Russia.
Ascentage Pharma will receive an option exercise fee, potential milestone and royalty payments, and a minority equity investment from Takeda.
The US drugmaker will continue all the clinical development works related to olverembatinib before the potential exercise of the option to license.
Takeda global oncology business unit president Teresa Bitetti said: “Takeda has a long history of driving important treatment advances for patients, particularly those with haematological cancers facing treatment gaps.
“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 leukaemia and other haematological cancers.
“This agreement aligns with our goal to support the advancement of both internal and external innovation to best serve patients.”
Olverembatinib is an oral, third generation BCR-ABL tyrosine kinase inhibitor (TKI) currently being developed for chronic myeloid leukaemia (CML) and other haematological cancers.
It is approved and marketed in China to treat TKI-resistant chronic-phase chronic myeloid leukaemia (CP-CML) or accelerated-phase CML (AP-CML) harbouring the T315I mutation.
The drug received orphan drug designation and Fast Track designation by the US Food and Drug Administration (FDA) and orphan designation by the European Medicines Agency (EMA).
Ascentage Pharma chairman and CEO Dajun Yang said: “We are thrilled to enter into this agreement with Takeda, which would allow us to leverage the global commercial expertise of an organisation with a proven track record and global oncology footprint to potentially broaden the impact olverembatinib could have on patients in need around the world.
“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.”
