$1.13 Billion Deal for Oral Metastatic Colorectal Cancer Therapy
HUTCHMED Limited today announced it entered into an exclusive license agreement with a subsidiary of Takeda Pharmaceutical Company Limited to further the global development, commercialization, and manufacture of fruquintinib.
Fruquintinib is orally administered and has the potential to be used across subtypes of metastatic colorectal cancer (“CRC”), regardless of biomarker status.
It is a highly selective and potent inhibitor of vascular endothelial growth factor receptors -1, -2, and -3.
CRC is a type of cancer that starts in either the colon or rectum.
Although early-stage CRC can be surgically resected, metastatic CRC remains an area of high unmet need with poor outcomes and limited treatment options.
HUTCHMED confirmed on January 23, 2023, it will receive up to US$1.13 billion, including US$400 million upfront on closing, as well as potential regulatory, development, and commercial sales milestone payments, plus royalties on net sales.
“Fruquintinib has the potential to change the treatment landscape for patients with refractory metastatic CRC who need additional treatment options. We look forward to utilizing our development and commercial capabilities to expand the potential of this innovative medicine to patients beyond China,” commented Teresa Bitetti, President of the Global Oncology Business Unit at Takeda, in a related press release.
Positive results of FRESCO-2, the global Phase III multi-regional clinical trial of fruquintinib in refractory metastatic CRC, were presented at the European Society for Medical Oncology Congress in September 2022. FRESCO-2 met its primary endpoint of improving overall survival in patients with metastatic CRC and was generally well tolerated.
According to the International Agency for Research on Cancer, CRC is the third most prevalent cancer worldwide, associated with more than 935,000 deaths in 2020.
In the U.S., an estimated 155,000 patients were diagnosed with CRC, and there were 54,000 related fatalities.
HUTCHMED stated it would continue to focus on progressing late-stage clinical trials and the commercialization of fruquintinib in mainland China in collaboration with Eli Lilly and Company, where it is approved under the brand name ELUNATE® for the treatment of patients with metastatic CRC who have been previously treated with fluoropyrimidine, oxaliplatin, and irinotecan, including those who have previously received anti-vascular endothelial growth factor therapy and/or anti-epidermal growth factor receptor therapy (RAS wild type).
ELUNATE has been included in the China National Reimbursement Drug List since January 2020 and was commercially launched in China in November 2018.