Takeda invests up to $1.3B for Ascentage leukemia drug option

Takeda has signed an agreement that may allow it to secure global rights to olverembatinib, a third-generation BCR-ABL tyrosine kinase inhibitor (TKI) developed by Chinese pharmaceutical company Ascentage Pharma. This drug is aimed at treating chronic myeloid leukemia (CML) and other hematological cancers. The deal, revealed on Friday, grants Takeda an exclusive option to license olverembatinib in all regions except China, Hong Kong, Macau, Taiwan, and Russia. Should Takeda exercise this option, it could potentially market a competitor to Novartis' approved CML medication, Scemblix (asciminib). Notably, Scemblix recently showcased positive frontline data at the American Society of Clinical Oncology (ASCO) annual meeting, which may significantly influence treatment decisions for first-line CML.

Teresa Bitetti, president of Takeda’s global oncology business unit, expressed optimism regarding the new agreement, citing the encouraging clinical results olverembatinib has demonstrated so far. According to the terms of the deal, Ascentage will continue to oversee all clinical development of olverembatinib until Takeda decides whether to license the drug.

Olverembatinib was approved in China in 2021 for adult patients with TKI-resistant chronic phase or accelerated-phase CML with the T315I mutation. As part of the agreement, Ascentage will receive an initial payment of $100 million upon the signing of the exclusive option. A Takeda spokesperson noted that the decision to exercise the licensing option will be based on specific, undisclosed development milestones. The timing will depend on the clinical development schedule, for which Ascentage will remain solely responsible.

If Takeda opts to license the drug, Ascentage stands to receive an option exercise fee, potential milestones amounting up to $1.2 billion, and double-digit royalties on future sales. Additionally, Takeda has committed to a $75 million investment in Ascentage, acquiring a minority equity stake in the company.