Takeda has entered into an exclusive licensing agreement with biopharma HUTCHMED, to develop and commercialise tyrosine kinase inhibitor fruquintinib, refractory metastatic colorectal cancer (CRC) for outside of mainland China, Hong Kong and Macau.
The agreement is valued up to $1.13 billion and strengthens Takeda’s growing oncology portfolio.
HUTCHMED will receive $400 million upfront as well as up to $730 million on meeting regulatory, development and commercial sales milestones. This is in addition to royalties on net sales.
Fruquintinib is a new oral, highly selective and potent inhibitor of vascular endothelial growth factor receptors (VEGFR) -1, 2 and 3. It has potential to be used across subtypes of CRC, regardless of biomarker status.
Marketing authorisation submissions for fruquintinib are planned in the US, Europe and Japan in 2023.
The Phase III trial for refractory metastatic CRC
In September 2022, results of FRESCO-2, the Phase III trial of fruquintinib in refractory metastatic CRC were presented at the European Society for Medical Oncology Congress. FRESCO-2 showed clinically meaningful improvement in overall survival in patients with metastatic CRC and was generally well tolerated.
Regulatory applications for fruquintinib
Fruquintinib was approved for marketing by the China National Medical Products Administration (NMPA) in September 2018. It was launched commercially in China in November 2018 under the brand name ELUNATE®.
In December 2022, HUTCHMED initiated a rolling submission of a New Drug Application (NDA) for fruquintinib with the US Food and Drug Administration (FDA). This is planned to be completed in the first half of 2023.
HUTCHMED plans to submit a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) and a JNDA to the Japan Pharmaceuticals and Medical Devices Agency (PMDA).
“Fruquintinib has the potential to change the treatment landscape for patients with refractory metastatic colorectal cancer who are in need of additional treatment options,” commented Teresa Bitetti, President of the Global Oncology Business Unit at Takeda.
The licensing deal is subject to customary closing conditions. Following these clearances, Takeda will become solely responsible for development and commercialisation of fruquintinib in all territories worldwide excluding mainland China, Hong Kong and Macau.
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