Alliances and Collaborations
Daiichi Sankyo Alliance
In November 2008, ArQule and Daiichi Sankyo Co., Ltd. entered into two agreements that form a strategic relationship for the development and discovery of novel oncology therapeutics. Under the first of these agreements, ArQule and Daiichi Sankyo will collaborate to conduct research, clinical trials and the market launch of ARQ 197, a proprietary, orally administered, small molecule inhibitor of the c-Met receptor tyrosine kinase, 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 and Taiwan, where Kyowa Hakko Kirin Co., Ltd. (see below) has exclusive rights for development and commercialization. The agreement provides for a $60 million cash upfront licensing payment from Daiichi Sankyo to ArQule. In addition, it 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 second agreement between ArQule and Daiichi Sankyo is a research collaboration, exclusive license and co-commercialization agreement under which ArQule will apply its proprietary technology and know-how from the ArQule Kinase Inhibitor Discovery (AKIP™) platform for the discovery of therapeutic compounds that selectively inhibit certain kinases. The agreement defines two such kinase targets, and Daiichi Sankyo will have an option to license compounds directed to these targets following the completion of certain pre-clinical studies. The agreement provides for a $15 million upfront payment, undisclosed payments in research support for the first and second years of the collaboration, licensing fees for compounds discovered as a result of this research, milestone payments related to clinical development, regulatory review and sales, and royalty payments. ArQule retains the option to co-commercialize licensed products in the U.S.
Kyowa Hakko Kirin Alliance
In April 2007, ArQule entered into an alliance with Kyowa Hakko Kirin Co., Ltd. to develop and commercialize ARQ 197 in Japan and parts of Asia. The agreement includes $123 million in upfront and potential development milestone payments from Kyowa to ArQule, including a $30 million cash upfront licensing payment. In addition, the agreement includes undisclosed sales milestone payments. Upon commercialization, ArQule will receive double-digit royalties from Kyowa on net sales of ARQ 197. Kyowa will be responsible for clinical development costs and commercialization of the compound in certain Asian countries, consisting of Japan, China (including Hong Kong), South Korea and Taiwan. In February 2008, ArQule received a $3 million milestone payment from Kyowa under this agreement, marking the initiation by Kyowa of a Phase 1, dose escalation trial in Japan with ARQ 197.
Non-oncology Collaborations
The following programs are derived from former chemistry technology collaborations. ArQule has received milestone payments under these collaborations. Should any of the compounds related to these programs proceed further in the clinic or become marketed drugs, under the terms of the agreements, ArQule will be eligible to receive further milestone payments and royalties.
Wyeth
Wyeth: Alzheimer's disease
Solvay
Solvay: Irritable bowel syndrome