Takeda has entered into an exclusive licensing agreement with Hutchmed China and its subsidiary Hutchmed Limited, for the further development and commercialization of fruquintinib outside of mainland China, Hong Kong and Macau.
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Approved in China in 2018, fruquintinib is a highly selective and potent inhibitor of vascular endothelial growth factor receptors (VEGFR) -1, 2 and 3. Fruquintinib is orally administered and has the potential to be used across subtypes of refractory metastatic colorectal cancer (CRC), regardless of biomarker status.
Positive results of FRESCO-2, the Phase 3 multi-regional clinical trial of fruquintinib in refractory metastatic CRC were presented at the European Society for Medical Oncology (ESMO) Congress in September 2022. FRESCO-2 met its primary endpoint of improving overall survival (OS) in patients with metastatic CRC and was generally well tolerated.
The U.S. Food and Drug Administration (FDA) granted Fast Track designation for the development of fruquintinib for the treatment of patients with metastatic CRC in 2020.
In December 2022, Hutchmed initiated a rolling submission of a New Drug Application (NDA) for fruquintinib with the U.S. FDA, which is planned to be completed in the first half of 2023.
This will be followed by planned submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) and a JNDA to the Japan Pharmaceuticals and Medical Devices Agency (PMDA).
Under the terms of the agreement, Takeda will receive an exclusive worldwide license to develop and commercialize fruquintinib in all indications and territories outside of mainland China, Hong Kong and Macau.
Subject to the terms of the agreement, Takeda will pay Hutchmed $400 million upfront, up to $730 million in additional potential payments relating to regulatory, development and commercial sales milestones, as well as royalties on net sales.
CRC is a cancer that starts in either the colon or rectum.
According to the International Agency for Research on Cancer, CRC is the third most prevalent cancer worldwide, associated with 935,000 deaths in 2020. In the U.S., an estimated 155,000 patients were diagnosed with CRC and there were 54,000 deaths from the disease.
In Europe, CRC was the second most common cancer in 2020 with approximately 520,000 new cases and 245,000 deaths. In Japan, CRC is the most common cancer with an estimated 148,000 new cases and 60,000 deaths in 2020.
Although early-stage CRC can be surgically resected, metastatic CRC remains an area of high unmet need with poor outcomes and limited treatment options. ■