Daiichi Sankyo and ArQule Enter Into Strategic R&D Partnership to Progress Novel Compounds to Target Cancer

Product Development Agreement Focused on ARQ 197, c-Met Inhibitor,

13-Nov-2008 - Japan

ArQule, Inc. and Daiichi Sankyo Co., Ltd. announced that they have entered into two agreements that form the basis of a strategic relationship for the development and discovery of novel oncology therapeutics. ArQule and Daiichi Sankyo will co-develop ARQ 197, a proprietary, orally administered, small molecule inhibitor of the c-Met receptor tyrosine kinase, to treat cancer. In addition, ArQule and Daiichi Sankyo will advance the application of ArQule's kinase inhibitor discovery platform (AKIP(TM)) to develop a new generation of highly selective, anti-cancer kinase inhibitors intended to ensure a long-term presence in this therapeutic category. On a combined basis, the two deals include$75 million in cash upfront to ArQule from Daiichi Sankyo.

ArQule and DAIICHI SANKYO have entered into a binding letter of intent for an exclusive license, co-development and co-commercialization agreement under which they shall collaborate to conduct research, clinical trials and the market launch of ARQ 197 in human cancer indications in the U.S., Europe, South America and the rest of the world, excluding Japan, China (including Hong Kong), South Korea andTaiwan, where Kyowa Hakko Kirin Co., Ltd. (Kyowa) has exclusive rights for development and commercialization.

The binding letter of intent provides for a$60 million cash upfront licensing payment from Daiichi Sankyo to ArQule. In addition, the binding letter of intent includes significant development and sales milestone payments. ArQule and Daiichi Sankyo will share equally the costs of Phase 2 and Phase 3 clinical studies, with ArQule's share of Phase 3 costs payable solely from milestone and royalty payments by Daiichi Sankyo. Upon commercialization, ArQule will receive tiered royalties from Daiichi Sankyo on net sales of ARQ 197. ArQule retains the option to participate in the commercialization of ARQ 197 in the U.S. The final contract based on the binding letter of intent, including the terms above, is expected to be signed in December 2008.

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