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February 4, 2014

Kyowa Hakko Kirin Announces Commencement of Phase 3 Clinical Study of ARQ 197 (Tivantinib) in Patients with Hepatocellular Carcinoma in Japan

Tokyo, Japan, February 4, 2014--- Kyowa Hakko Kirin Co., Ltd. (Tokyo: 4151, President and CEO: Nobuo Hanai, "Kyowa Hakko Kirin") today announced the initiation of a phase 3 clinical study evaluating ARQ 197 (tivantinib) in Japanese patients with c-Met diagnostic-high inoperable hepatocellular carcinoma treated with one prior sorafenib therapy.

This is a randomized, double-blind placebo-controlled study to compare progression-free survival (PFS) of ARQ197 versus placebo. One-hundred-sixty patients is planned to be enrolled to this study.

ARQ 197, an oral agent whose molecular target is c-MET, was 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.

Kyowa Hakko Kirin has four strategic categories including the oncology area, and is endeavoring to contribute to the treatment of cancer patients through the further development of anticancer agents.

About c-Met
C-Met is receptor tyrosine kinase. When abnormally activated, the c-Met receptor tyrosine kinase plays multiple roles in aspects of human cancer, including cancer cell growth, survival, angiogenesis, invasion and metastasis.

About ArQule
ArQule is a biotechnology company in the United States engaged in the research and development of next-generation, small molecule cancer therapeutics.

About four categories
These are the following four disease areas: Nephrology, Oncology, Immunology&Allergy and Central Nervous System, as presented in Kyowa Hakko Kirin's FY 2013-2015 medium-term business plan.

Study name: JET-HCC

Outline of the Phase 3 Trial of ARQ 197 in Patients with Hepatocellular Carcinoma Identifier NCT02029157
Target Population C-Met high inoperable hepatocellular carcinoma patients treated with one prior sorafenib therapy
Trial Design Multi-center, randomized double-blind, placebo-controlled trial
Dose One tablet of the trial drug (ARQ 197 120 mg or Placebo) is daily administered to the subjects of each group twice in a day
Target Number of Subjects 160
Primary Objective Progression-free survival
Trial Location Japan
Trial Duration Jan. 2014 to Dec. 2016


Kyowa Hakko Kirin
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