Exelixis Expands the Cabozantinib Development Program Through NCI-CTEP Collaboration

Exelixis, Inc.

today announced a broad expansion of the cabozantinib development program under a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute's Cancer Therapy Evaluation Program (NCI-CTEP), with the approval of the initial program of 12 proposed clinical trials under the agreement. The CRADA provides for funding for as many as 20 active clinical trials each year for a five year period, which Exelixis believes will allow it to broadly expand the cabozantinib development program in a cost-efficient manner. When initiated, these trials will substantially increase the number of indications and disease settings in which cabozantinib is being investigated and aid in prioritizing the next set of pivotal trials. Cabozantinib is a potent, first-in-class, tyrosine kinase inhibitor that simultaneously targets the MET and VEGF signaling pathways. In clinical studies, cabozantinib has demonstrated a unique spectrum of anti-tumor activity in 12 out of 13 tumor types tested, with regression of metastatic or primary tumor lesions in soft tissue, visceral organs and the brain, resolution of bone lesions on bone scan, and substantial reductions in pain and narcotic use in patients with castration-resistant prostate cancer (CRPC). Exelixis initiated a rolling submission of a new drug application (NDA) for cabozantinib in medullary thyroid cancer in December 2011 based on the positive top-line results in the phase 3 EXAM trial announced in October 2011. The NDA submission is expected to be completed in the first half of this year. Cabozantinib is currently in phase 3 clinical development in CRPC.