Kyowa Hakko Kirin initiates Phase 2 trial of ARQ 197 for gastric cancer: ArQule

ArQule, Inc. (Nasdaq: ARQL) today announced the initiation of a Phase 2, single agent trial with ARQ 197 in gastric cancer by Kyowa Hakko Kirin, its exclusive licensee for the development and commercialization of ARQ 197 in the Asian territory consisting of Japan, China (including Hong Kong), South Korea and Taiwan. Initiation of this trial will trigger a $5 million milestone payment to ArQule from Kyowa Hakko Kirin.

“We welcome the expansion by Kyowa Hakko Kirin of its development program with ARQ 197 into gastric cancer”

"We welcome the expansion by Kyowa Hakko Kirin of its development program with ARQ 197 into gastric cancer," said Paolo Pucci, chief executive officer of ArQule. "We believe this indication may have particular promise in Asia, where the incidence of this cancer is among the highest in the world and where it is the second most common cause of cancer-related death."

The primary objective of this trial is to determine disease control rate, defined as a combination of objective responses and stable disease. Secondary objectives include tumor response, progression-free survival and overall survival. Approximately 30 patients will be enrolled at clinical trial sites in Japan and Korea.

Every year, approximately 930,000 new cases of gastric cancer are diagnosed, and approximately 700,000 people die of the disease worldwide. Gastric cancer is the second leading cause of cancer death worldwide, and the disease is more common in East Asian countries such as Japan and Korea than in western countries.

Under the terms of its ARQ 197 license agreement with Kyowa Hakko Kirin, ArQule is entitled to specified development and regulatory milestone payments totaling $123 million, which include a $30 million upfront licensing payment and a $3 million development milestone payment previously received. Upon the commercialization of ARQ 197 in Asian territories, ArQule will receive tiered royalties from Kyowa Hakko Kirin on net sales in the mid-teen to low-twenty percent range, as well as potential sales milestone payments. Kyowa Hakko Kirin is responsible for clinical development costs and commercialization of the compound in Asia.

ARQ 197 is an orally available, small molecule inhibitor of the c-Met receptor tyrosine kinase. ArQule's partner for the development of ARQ 197 in the rest of the world excluding the Asian territories covered by its agreement with Kyowa Hakko Kirin is Daiichi Sankyo, Co., Ltd.

SOURCE ArQule