Takeda Partners With Ascentage in Promising New CML Drug Development
Takeda partners with Ascentage for global rights to CML drug olverembatinib, excluding China and others.
Breaking News
Jun 17, 2024
Mrudula Kulkarni
Pharmaceutical giant Takeda has entered into an option
agreement with Ascentage Pharma for an exclusive license to olverembatinib,
aimed at treating chronic myeloid leukemia (CML) and other blood cancers. If
Takeda exercises this specific option, they would be able to gain the global
rights to develop and market olverembatinib in all regions except mainland
China, Russia, Taiwan, Macau and Hong Kong. In return, Ascentage will obtain a
$100 million option payment upon the execution of the exclusive option
agreement with Takeda, along with a minority equity investment. Additionally,
Ascentage stands to receive an option exercise fee, as well as potential
milestone and royalty payments contingent upon regulatory approvals.
Olverembatinib, a tyrosine kinase inhibitor (TKI), is
approved and sold under the brand name Nelic in China for treating adult
patients with TKI-resistant chronic-phase CML (CP-CML) or accelerated-phase CML
(AP-CML) who have the T315I mutation. It is also used for patients with CP-CML
who are resistant to or cannot tolerate first and second-generation TKIs. As
reported by GlobalData’s Pharma Intelligence Center, Nelic is projected to
generate $92 million in 2030. GlobalData is the parent company of Pharmaceutical
Technology.
According to the agreement, Ascentage will remain solely
responsible for all clinical development of olverembatinib until the potential
licensing option is exercised. Currently, the drug is being studied in a Phase
III POLARIS-2 registrational trial (NCT06423911), which aims to enroll 285
patients with CML.
In the previous month, Takeda announced a $900 million
restructuring plan following a more than 50% drop in annual profits for the
financial year 2023. During an earnings call, the company reported progress on
six late-stage programs, one of which involves therapies for treating rare
blood disorders, indicating their potential to generate significant value.
Takeda has a long history with tyrosine kinase inhibitors
(TKIs). In October 2023, the Japanese pharmaceutical company had to withdraw
its TKI Exkivity (mobocertinib) after its Phase III trial failed to achieve its
primary endpoint. Exkivity had previously received accelerated approval from
the US Food and Drug Administration (FDA) for treating adults with locally
advanced or metastatic non-small cell lung cancer (NSCLCC).
“We are very encouraged by the promising clinical results of
olverembatinib so far and are excited about the possibility of further
developing and delivering it to patients with chronic myeloid leukemia and
other hematological cancers, said Teresa Bitetti, president of Takeda’s Global
Oncology Business Unit.