Ipsen, the European partner of Exelixis has announced that Cabometyx (cabozantinib) has been approved by the European Union for an expanded indication. The company’s Cabometyx 20 mg, 40 mg and 60 mg were approved in the EU for treatment of adults with intermediate and poor-risk advanced renal cell carcinoma (RCC).
This approval was expected earlier in March after the company was positively reviewed by the Committee for Medicinal Products for Human Use (“CHMP”) for use of Cabometyx.
In granting the approval in the first-line setting, the EU was guided by the results obtained from the CABOSUN trial. The trial met the primary endpoint of improving progression-free survival as compared to Pfizer’s PFE Sutent (sunitinib) in advanced RCC patients that were initially untreated.
Cabometyxis is used in the European Union for treatment of advanced RCC that come as a result of vascular endothelial growth factor (VEGF)-targeted therapy. In December last year, Cabometyx was approved in the United States for first-line treatment of advanced RCC.
In the first quarter of 2018, Cabometyx generated net revenues amounting to $128.9 million. The revenues were mainly as a result of growing demand in the United States following the approval in the first line setting. The company is expected to record even higher revenues following the approval in the European Union.
According to the terms of the partnership with Ipsen, Exelixis will be entitled to $50 million in milestone payments following the EU approval. A sum of around $46 million was reported as the collaboration revenue in the first quarter of 2018. Ipsen is expected to make the payment in the next 70 days.
Exelixis’ shares have slumped 32.8% in the last one year, which is a bigger margin compared to the industry’s drop of 3.6%.
Exelixis entered into a partnership and licensed agreement with Ipsen in 2016 for marketing and development of cabozantinib. Under the partnership Ipsen got exclusive commercialization rights for the current as well as future indications of cabozantinib in Canada, United States and Japan.
Exelixis has signed an agreement with Roche Holding RHHBY and Bristol-Myers BMY toward the development of cabozantinib plus other immunotherapy agents in 2017.
Exelixis President and Chief Executive Officer, Michael M. Morrissey, Ph.D said that the approval of CABOMETYX is a big milestone for the company as well as patients who need alternative treatment options. He added that they are hopeful that the partnership will benefit both the company and the patients.