Exelixis’ Partner Ipsen Announces Positive CHMP Opinion for CABOMETYX® (cabozantinib) for Previously Untreated Intermediate- or Poor-Risk Advanced Renal Cell Carcinoma

Exelixis, Inc. (NASDAQ:EXEL) today announced that its partner Ipsen has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), for CABOMETYX® (cabozantinib) 20 mg, 40 mg and 60 mg for the first-line treatment of adults with intermediate- or poor-risk advanced renal cell carcinoma (RCC). The positive CHMP opinion will now be reviewed by the European Commission, which has the authority to approve medicines for the European Union.

“This positive CHMP opinion represents a significant step forward in helping to address an unmet need for patients in Europe with intermediate- or poor-risk advanced RCC, who often fare poorly and are in need of new therapies to better control their disease,” said Michael M. Morrissey, Ph.D., President and Chief Executive Officer of Exelixis. “This is an important milestone in our collaboration with Ipsen as we work together to bring CABOMETYX to more patients with advanced kidney cancer and as we continue to study its potential in additional types of cancer.”

Under the terms of the Collaboration and License Agreement with Ipsen, Exelixis is eligible to receive a milestone payment of $50 million for the approval of the first-line treatment of advanced RCC, of which approximately $46 million will be recognized as collaboration revenue in the first quarter 2018. This milestone will be paid by Ipsen within 70 days after notification of the approval decision by the European Commission.

CABOMETYX was approved in the European Union in September 2016 for the treatment of advanced RCC in adults following prior vascular endothelial growth factor (VEGF)-targeted therapy. The CHMP recommendation to expand the indication is based on results of the CABOSUN trial, which met its primary endpoint of improving progression-free survival (PFS) compared with sunitinib in patients with previously untreated advanced RCC determined to be intermediate- or poor-risk by the International Metastatic RCC Database Consortium (IMDC) criteria. In December 2017, the U.S. Food and Drug Administration (FDA) approved CABOMETYX for the expanded indication of patients with advanced RCC based on the results from the CABOSUN trial.