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August 9, 2011

Kyowa Hakko Kirin Announces Commencement of
Phase 3 International Clinical Study of ARQ 197 (Tivantinib) in Patients with
Non-Small Cell Lung Cancer in Asia

Tokyo, Japan, August 9, 2011--- Kyowa Hakko Kirin Co., Ltd. ("Kyowa Hakko Kirin") has announced the commencement of an international phase 3 clinical study evaluating the combination of ARQ 197 (tivantinib) and erlotinib in patients with advanced or metastatic non-small cell lung cancer in Asia (Japan, Korea, and Taiwan).

This study is a randomized, double-blind trial comparing overall survival (OS) of patients treated with ARQ 197 and erlotinib to OS of patients treated with placebo and erlotinib. The target number of patients to be enrolled in this study is 460.

ARQ 197 is an orally available, selective inhibitor of the c-Met receptor tyrosine kinase discovered by ArQule, Inc. (NASDAQ: ARQL). Kyowa Hakko Kirin signed a license agreement with ArQule for the exclusive rights to the development and sales of ARQ 197 in Japan and some parts of Asia (China, Korea, and Taiwan) on April 27th, 2007.

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 ArQule overseas. In addition to the Phase 3 trial, Kyowa Hakko Kirin is conducting a phase 2 international study with ARQ 197 in patients with previously treated advanced/recurrent gastric cancer in Asia (Japan and Korea).

Kyowa Hakko Kirin aims to contribute to human health and well being worldwide through innovative drug discovery and global commercialization driven by state-of-the-art biotechnology.


About ARQ 197 (tivantinib)
ARQ 197 is an orally administered low molecular weight compound discovered by ArQule, which selectively inhibits c-Met (receptor tyrosine kinase). c-Met is a hepatocyte growth factor receptor with a high level of expression and activity in a wide variety of solid cancers. The expression of c-Met is reported as being related to the infiltration and metastasis of cancer and correlated with the malignancy of cancer.

About Erlotinib
Erlotinib is an orally administered molecularly targeted drug that selectively inhibits tyrosine kinase in epidermal growth factor receptors. It is indicated for non-small cell lung cancer and marketed under the brand name Tarceva®.

About Non-small cell lung cancer
Lung cancer can be categorized into two major categories: small cell lung cancer and non-small cell lung cancer. Non-small cell lung cancer can be further categorized into squamous cell carcinoma, adenocarcinoma, and large cell carcinoma. This clinical study is conducted with non-small cell carcinoma, excluding squamous cell carcinoma, as the indication.

About ArQule
ArQule is a biotechnology company in the United States engaged in the research and development of next-generation, small molecule cancer therapeutics.
URL: http://www.arqule.com/


Study name : ATTENTION


Ongoing Clinical Studies of ARQ 197 in Asia
ClinicalTrials.gov
Identifier
Phase
Country
Study
3
Japan
Korea
Taiwan
A Phase 3, Randomized,
Double-Blinded, Placebo-Controlled Study of ARQ 197 Plus Erlotinib
Versus Placebo Plus Erlotinib (NSCLC)
2
Japan
Korea
Study of ARQ 197 Monotherapy (ARQ 197-004)
(Gastric cancer)



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