On August 9, 2011, Kyowa Hakko Kirin Co., Ltd., ("Kyowa Hakko Kirin") the licensee of ArQule, Inc. (“the Registrant”) for the exclusive rights to the development and sales of tivantinib (ARQ 197) in Japan and certain other countries in Asia (China, Korea, and Taiwan) announced dosing of the first patient in its Phase 3 trial of tivantinib in combination with erlotinib in NSCLC patients in Asia. Dosing of the first patient in this trial triggers a milestone payment in the amount of $10 million to the Registrant from Kyowa Hakko Kirin.
The Phase 3 trial is a randomized, double-blinded, placebo controlled clinical trial of tivantinib in combination with erlotinib in NSCLC patients with wild-type EGFR. The trial is designed to compare overall survival (OS) of patients treated with tivantinib and erlotinib to OS of patients treated with placebo and erlotinib. The design of the Phase 3 clinical trial is based on the results of the clinical studies in Japan by Kyowa Hakko Kirin and those by the Registrant in the United States and Europe.