Takeda inks option deal with Ascentage for CML drug

Takeda has recently entered into an option agreement with Ascentage Pharma, allowing it to pursue an exclusive licence agreement for olverembatinib, a tyrosine kinase inhibitor (TKI) targeting chronic myeloid leukemia (CML) and other haematological cancers. This strategic move is aimed at expanding Takeda's oncology portfolio, particularly in treating blood-related malignancies.

Under the terms of the agreement, Takeda can acquire global rights to develop and commercialize olverembatinib, with the exception of territories including mainland China, Hong Kong, Macau, Taiwan, and Russia. As part of the agreement, Ascentage Pharma will receive a $100 million upfront payment from Takeda, as well as a minority equity investment. Further financial incentives for Ascentage include an option exercise fee and potential milestone and royalty payments, contingent upon regulatory approvals and commercial success.

Olverembatinib, marketed as Nelic in China, is already approved for treating adult patients with chronic-phase CML (CP-CML) or accelerated-phase CML (AP-CML) who have the T315I mutation and are resistant to previous TKI treatments. Additionally, it is used for patients who are intolerant or resistant to first- and second-generation TKIs. According to forecasts by GlobalData’s Pharma Intelligence Center, Nelic is expected to generate $92 million in revenue by 2030.

Ascentage Pharma will retain responsibility for the clinical development of olverembatinib until Takeda exercises its option to license the drug. Currently, olverembatinib is undergoing a Phase III POLARIS-2 registrational study, which aims to enroll 285 CML patients. This study is pivotal in determining the future commercial pathway for the drug.

This collaboration comes at a crucial time for Takeda, which recently announced a $900 million restructuring plan following a significant decline of over 50% in its annual profits for the fiscal year 2023. During an earnings call, Takeda highlighted progress in six late-stage programs that could deliver substantial value, including treatments for rare blood disorders.

Takeda has a long-standing involvement with TKIs. However, it faced a setback in October 2023 when it had to withdraw Exkivity (mobocertinib) after a Phase III trial failed to meet its primary endpoint. Exkivity had initially received accelerated approval from the US Food and Drug Administration (FDA) for treating adult patients with advanced non-small cell lung cancer (NSCLC).

Despite recent challenges, Takeda remains optimistic about the potential of olverembatinib. Teresa Bitetti, the president of Takeda's Global Oncology Business Unit, expressed enthusiasm about the promising clinical results shown by olverembatinib and the opportunity to further develop and deliver this treatment to patients with CML and other haematological cancers.

The collaboration between Takeda and Ascentage Pharma underscores the ongoing innovation and strategic partnerships within the biopharmaceutical industry, particularly in the field of oncology. As the sector continues to evolve, companies are seeking new avenues for growth and competitiveness, navigating the complex landscape shaped by technological advancements, regulatory changes, and market dynamics. This agreement represents a significant step in addressing unmet medical needs and enhancing treatment options for patients with challenging haematological conditions.