Saturday, July 13, 2024

Leukemia Treatment Advancements: Takeda and Ascentage Pharma Partner on Olverembatinib Development

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In a significant move within the pharmaceutical industry, Takeda and Ascentage Pharma have signed an option agreement for the development and commercialization of olverembatinib, a promising therapy for chronic myeloid leukemia and other hematological cancers. This agreement represents a strategic alliance aimed at leveraging Takeda’s global expertise to potentially make olverembatinib accessible to a broader patient population outside of China, Macau, Hong Kong, Taiwan, and Russia.

If Takeda exercises its option, it will secure the global rights to develop and commercialize olverembatinib, except in the aforementioned regions. Ascentage Pharma will retain sole responsibility for the clinical development of the drug until Takeda potentially takes over. This partnership could see Ascentage Pharma benefiting from an upfront payment of $100 million, an option exercise fee, and additional milestone and royalty payments.

Takeda Invests in Ascentage Pharma to Globally Expand Olverembatinib for Leukemia

Olverembatinib, already approved in China for treating TKI-resistant chronic-phase chronic myeloid leukemia or accelerated-phase chronic myeloid leukemia with the T315I mutation, has shown a significant impact on patients. Dr. Dajun Yang, chairman and CEO of Ascentage Pharma, expressed optimism about the collaboration, highlighting its potential to expand olverembatinib’s reach globally.

As part of the deal, Takeda will also make a minority equity investment in Ascentage Pharma. This strategic move underscores Takeda’s commitment to advancing olverembatinib’s development through POLARIS-2, a global Phase III study focused on previously treated adult patients with CP-chronic myeloid leukemia, with or without the T315I mutation. The decision to proceed will hinge on customary regulatory approvals, ensuring that the therapy meets international standards for safety and efficacy.


Takeda and Ascentage Pharma Collaborate to Expand Global Access to Olverembatinib for Leukemia

Takeda could gain global rights to olverembatinib, excluding China, Macau, Hong Kong, Taiwan, and Russia. Ascentage Pharma will oversee clinical development until Takeda exercises its option. Olverembatinib is already approved in China for specific chronic myeloid leukemia patients. The agreement includes a $100 million upfront payment and potential additional financial benefits for Ascentage Pharma.

The collaboration between Takeda and Ascentage Pharma marks a pivotal moment in the fight against hematological cancers. By combining Ascentage Pharma’s innovative research with Takeda’s global commercial capabilities, this partnership aims to enhance the availability of olverembatinib to a wider patient population. Stakeholders should monitor the progression of POLARIS-2 and regulatory approvals closely, as these will be critical in determining the therapy’s global impact. The financial terms of the agreement highlight the significant value placed on olverembatinib’s potential, signaling robust confidence in its efficacy and marketability. This partnership holds promise for advancing cancer treatment and improving patient outcomes worldwide.


Resource: Ascentage Pharma, June 14, 2024

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