Takeda Pharmaceutical negotiated an exclusive license from Exelixis to develop and commercialize the latter’s anticancer drug cabozantinib in Japan for all cancer indications. Cabozantinib is approved and marketed as Cabometyx™ in the EU and U.S. for treating advanced renal cell carcinoma (RCC), but has not been commercialized in Japan, although early-stage clinical trials have previously been carried out in the country.

Under terms of the deal, Takeda will pay Exelixis $50 million upfront and potentially another $95 million in development, regulatory, and first-sales milestones for the first three planned indications, plus royalties on sales. Exelixis also retains its exclusive rights to develop and commercialize cabozantinib in the U.S., while its European partner Ipsen holds exclusive ex-U.S and ex-Japan commercialization rights to the drug.

“As an organization with a strong focus on oncology innovation, our agreement with Exelixis brings a promising and well-studied solid-tumor therapy to our pipeline that may help patients in Japan suffering from RCC and potentially other equally devastating cancers,” said Tsudoi Miyoshi, head of Takeda’s Japan Oncology Business Unit. “We intend to pursue regulatory approval for RCC indications as soon as we’re able, and look forward to commencing the local clinical trial program to further strengthen the clinical profile of cabozantinib.”

Takeda and Exelixis will work together on clinical development of cabozantinib for the Japanese market. This will include leveraging existing clinical data and results from ongoing and planned pivotal and earlier-stage studies in a range of tumor types, including hepatocellular cancer, colorectal cancer, bladder cancer, non-small-cell lung cancer, and endometrial cancer. More than 45 studies are anticipated through the National Cancer Institute’s Cancer Therapy Evaluation Program and investigator-sponsored trials.

“We look forward to supporting our new partner as it pursues Japanese regulatory approval for cabozantinib, while simultaneously working together to plan the next steps for clinical development in the country,” added Michael M. Morrissey, Ph.D., Exelixis president and CEO. “This agreement further propels the global progress for cabozantinib development and commercialization, which now includes the recent first commercial sale of Cabometyx in the United Kingdom, triggering a $10 million milestone payment from Ipsen to Exelixis.”

Cabozantinib was approved in the U.S. in April 2016 and in the EU in September 2016 for treating advanced RCC in patients who have received previous antiangiogenic treatment. Also during September, the firm reported positive data from the Phase II Cabosun study evaluating cabozantinib in patients with previously untreated advanced RCC. The trial results showed that cabozantinib therapy in comparison with sunitinib reduced the rate of diseases progression or death by 31%.

Cabozantinib development has not been straightforward for Exelixis. Back in 2014, the drug bombed in its pivotal trial for the initial indication of metastatic castration-resistant prostate cancer (mCRPC), forcing Exelixis to axe 70% of its workforce in a bid to conserve the cash needed to complete Phase III RCC development.

Takeda has started 2017 with a string of collaborations, license agremeents, and M&A deals, topped by its agreed $5.2 billion acquisition of Ariad Pharmaceuticals. Also in January, Takeda inked an epilepsy drug collaboration with Ovid Pharmaceuticals, announced a partnership with LegoChem to evaluate next-generation antibody drug conjugates, and negotiated an option to acquire Maverick Therapeutics as part of a T-cell redirection therapy collaboration. At the start of January, Takeda agreed to fund development of PvP Biologics' celiac therapeutic KumaMax.  

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