Exelixis announces regaining of rights to develop and commercialize XL184

Exelixis, Inc. (Nasdaq:EXEL) today announced that it has regained full rights to develop and commercialize XL184. Exelixis and Bristol-Myers Squibb Company (BMS) entered into a global development collaboration for XL184, the clinically most advanced MET inhibitor, in December 2008. Under the agreement, BMS and Exelixis had originally agreed to certain clinical development plans, and Exelixis maintained key rights regarding timing and funding of current and future clinical trials. Given the recent progress of BMS' wholly-owned oncology pipeline and positive data generated by XL184, Exelixis and BMS were not able to align on the scope, breadth and pace of the ongoing clinical development of XL184. As a result, BMS returned XL184 to Exelixis, thereby giving Exelixis the opportunity to advance the program as originally envisioned. BMS will make a payment to Exelixis of $17 million in connection with the return of XL184.

“We believe in the clinical and commercial potential of XL184 in a broad array of cancer indications. The data that we recently presented at ASCO were encouraging”

"We believe in the clinical and commercial potential of XL184 in a broad array of cancer indications. The data that we recently presented at ASCO were encouraging," said George A. Scangos, Ph.D., president and chief executive officer of Exelixis. "We certainly understand BMS' need to make pipeline and prioritization decisions, but from Exelixis' perspective, XL184 is our most advanced compound, the data are encouraging, and we need to rapidly develop the compound in indications justified by the data, including medullary thyroid cancer, glioblastoma, and potentially some of the major tumor types being evaluated in the randomized discontinuation trial. We regret BMS' decision, but we are pleased to now have the opportunity to develop XL184 independent of divergent pipeline and portfolio considerations. It is a sign of the strength of our relationship that we could achieve this outcome for XL184 at the same time that we continue our positive collaborations around a number of other compounds. We have the resources to take XL184 forward on our own for some time and we see several attractive longer term options, which we are currently evaluating."

XL184 Clinical Development Program

XL184 is currently being evaluated in 13 tumor types across multiple clinical trials. As recently reported at the 2010 Annual Meeting of the American Society of Clinical Oncology (ASCO) in early June, in an expanded cohort in phase 1 of patients with medullary thyroid cancer, XL184 demonstrated a 29% response rate, with a median duration of response that had not yet been reached, with a range of 4 to 35+ months. XL184 is currently being evaluated in a pivotal phase 3 clinical trial in patients with medullary thyroid cancer. Assuming positive results from the pivotal trial, Exelixis anticipates submitting a new drug application (NDA) with the Food and Drug Administration for XL184 in this indication in 2011. Also as reported at the 2010 ASCO Annual Meeting, in a phase 2 clinical trial in patients with recurrent glioblastoma, XL184 demonstrated a 30% response rate when dosed at 125 mg daily, with a median duration of response of 5.1 months. Exelixis expects to initiate a phase 3 pivotal trial in recurrent glioblastoma in the year-end 2010 time frame. In addition, as reported at the 2010 ASCO Annual Meeting, objective responses with XL184 have been observed in patients with refractory melanoma, non-small cell lung cancer (NSCLC) (both as a single agent and in combination with erlotinib), hepatocellular carcinoma, prostate and ovarian cancers in an ongoing adaptive randomized discontinuation trial (RDT). Exelixis expects to prioritize tumor types from the RDT for further development early in 2011.