This press release contains forward-looking statements regarding the progress of the Companies' phase II and phase III clinical trials with ARQ 197. These statements are based on the Companies' 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. 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 Companies or their collaborators 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 Companies' views of the data or require additional data, information or studies. 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. In addition, the planned timing of initiation and completion of clinical trials for ARQ 197 is subject to the ability of the Companies 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 commercialisation 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.
---------------------------------
[1] International Agency for Cancer Research, URL: http://globocan.iarc.fr/factsheets/cance.... Last accessed November 10, 2010.
[2] American Cancer Society. Lung Cancer. URL: http://www.cancer.org/Cancer/LungCancer-Non-SmallCell/Overvi... Last accessed November 10, 2010.
[3] American Cancer Society. Lung Cancer. URL: http://www.cancer.org/Cancer/LungCancer-Non-SmallCell/Overvi... Last accessed November 9, 2010.
[4](GLOBOCAN 2008) International Agency for Research on Cancer: http://globocan.iarc.fr
[5] American Cancer Society. Lung Cancer. URL: http://www.cancer.org/Cancer/LungCancer-Non-SmallCell/Detail... Last accessed November 9, 2010.
(Due to the length of these URLs, it may be necessary to copy and paste the hyperlinks into your Internet browser's URL address field. Remove the space if one exists.)
For more information, please contact:
William B. Boni
ArQule, Inc.
+1(781)994-0300
Toshiaki Sai
Daiichi Sankyo, Co., Ltd. (Japan)
+81-3-6225-1126
Kimberly Wix
Daiichi Sankyo, Inc. (US)
+1(973)944-2338
Tetsuya Ohira
Daiichi Sankyo Europe
+49(0)89-7808-694
CONTACT: William B. Boni, ArQule, Inc., +1(781)994-0300; Toshiaki Sai,Daiichi Sankyo, Co., Ltd. (Japan), +81-3-6225-1126; Kimberly Wix, DaiichiSankyo, Inc. (US), +1(973)944-2338, Tetsuya Ohira, Daiichi Sankyo Europe,+49(0)89-7808-694
