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ArQule Announces Initiation by Kyowa Hakko Kirin of Phase 2 Clinical Trial in Asia with ARQ 197 in Gastric Cancer
WOBURN, Mass., Jul 28, 2010 (BUSINESS WIRE) -- 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," 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.
About ArQule
ArQule is a biotechnology company engaged in the research and development of next-generation, small-molecule cancer therapeutics. The Company's targeted, broad-spectrum products and research programs are focused on key biological processes that are central to human cancers. ArQule's lead product, in Phase 2 clinical development, is ARQ 197, an inhibitor of the c-Met receptor tyrosine kinase. The Company is also conducting Phase 1 clinical testing with ARQ 621, designed to inhibit the Eg5 kinesin motor protein. The Company's pre-clinical pipeline includes a compound designed to inhibit the B-RAF kinase. ArQule's current discovery efforts, which are based on the ArQule Kinase Inhibitor Platform (AKIP(TM)), are focused on the identification of novel kinase inhibitors that are potent, selective and do not compete with ATP (adenosine triphosphate) for binding to the kinase. The most advanced AKIP(TM) program is focused on the discovery of inhibitors of fibroblast growth factor receptor (FGFR).
This press release contains forward-looking statements regarding the progress of the Company's Phase 2 clinical trial with ARQ 197 in gastric cancer conducted by Kyowa Hakko Kirin under its agreement with the Company. These statements are based on the Company's current beliefs and expectations, and are subject to risks and uncertainties that could cause actual results to differ materially. Positive information about early stage clinical trial results is not necessarily indicative of clinical efficacy and does not ensure that later stage or larger scale clinical trials will be successful. For example, ARQ 197 may not demonstrate promising therapeutic effect; in addition, this compound may not demonstrate an appropriate safety profile in further pre-clinical testing and in current, later stage or larger scale clinical trials as a result of known or as yet unanticipated side effects. The results achieved in later stage trials may not be sufficient to meet applicable regulatory standards. Problems or delays may arise during clinical trials or in the course of developing, testing or manufacturing these compounds that could lead the Company or its partner to discontinue development. Even if later stage clinical trials are successful, the risk exists that unexpected concerns may arise from analysis of data or from additional data or that obstacles may arise or issues be identified in connection with review of clinical data with regulatory authorities or that regulatory authorities may disagree with the Company's view of the data or require additional data, information or studies. In addition, the planned timing of initiation and completion of clinical trials for ARQ 197 are subject to the ability of Kyowa Hakko Kirin, a licensee of ARQ 197, to enroll patients, enter into agreements with clinical trial sites and investigators, and other technical hurdles and issues that may not be resolved. Drug development involves a high degree of risk. Only a small number of research and development programs result in the commercialization of a product. Furthermore, ArQule may not have the financial or human resources to pursue drug discovery successfully in the future. For more detailed information on the risks and uncertainties associated with the Company's drug development and other activities see the Company's periodic reports filed with the Securities and Exchange Commission. The Company does not undertake any obligation to publicly update any forward-looking statements.
SOURCE: ArQule, Inc.
ArQule, Inc.
William B. Boni, 781-994-0300
VP, Investor Relations/
Corp. Communications
www.ArQule.com
Copyright Business Wire 2010