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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.

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  • Jun 17, 2024

  • Mrudula Kulkarni

Takeda Partners With Ascentage in Promising New CML Drug Development

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. 


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