San Francisco-based drug discovery company Exelixis is to collaborate with Japanese pharma giant Takeda in the development of Exelixis’ lead cancer candidate cabozantinib.
Cabozantinib is a tyrosine kinase inhibitor for both c-Met and VEGFR2 molecules, both of which have been shown to have key roles in tumour growth, metastasis, and angiogenesis (the formation of new blood vessels).
The deal will see Takeda gaining the exclusive developmental and commercial rights for all future indications of cabozantinib in Japan, including in renal cell carcinoma (RCC) for which cabozantinib is already marketed in the US and EU under the brand name CABOMETYX.
Exelixis will maintain exclusive rights to develop and commercialise cabozantinib in the US, whilst its partner Ipsen will maintain exclusive commercialisation rights for current and potential future cabozantinib indications outside the US and Japan.
In terms of revenue, Exelixis will initially receive $50 million as an upfront payment followed by $95 million in development, regulatory and first-sales milestone payments for its first three planned indications, as well as royalties from Takeda sales.
“As an organisation with a strong focus on oncology innovation, our agreement with Exelixis brings a promising and well-studied solid-tumour therapy to our pipeline that may help patients in Japan suffering from RCC and potentially other equally devastating cancers,” said Tsudoi Miyoshi, head of Japan Oncology Business Unit of Takeda. “We intend to pursue regulatory approval for RCC indications as soon as we’re able, and look forward to commencing the local clinical trial programme to further strengthen the clinical profile of cabozantinib.”
Cabozantinib has already impressed in previous trials. In its pivotal METEOR trial, the drug led to significant improvements in overall survival, progression-free survival and objective response rate.
The company’s CELESTIAL trial is now testing cabozantinib in advanced hepatocellular carcinoma (HCC) – the world’s most common form of liver cancer – whilst other trials are underway investigating the drug in bladder, colorectal, non-small cell lung and endometrial cancer.
“Takeda is the ideal partner to advance cabozantinib in Japan and deliver this important treatment option to Japanese patients with cancer,” said Michael M. Morrissey, president and chief executive officer of Exelixis. “This agreement further propels the global progress for cabozantinib development and commercialisation, which now includes the recent first commercial sale of CABOMETYX in the United Kingdom, triggering a $10 million milestone payment from Ipsen to Exelixis.”