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Astellas Enters License Agreement with Janssen to Develop and Commercialize ASP015K, an Astellas? Oral JAK Inhibitor for Immunologic Diseases

TOKYO, October 2, 2012 - Astellas Pharma Inc. (“Astellas”; Tokyo:4503; President and CEO: Yoshihiko Hatanaka) announced today the execution of a license agreement with Janssen Biotech, Inc. (“Janssen”) under which Janssen has an exclusive right to develop and commercialize ASP015K, an Astellas compound, worldwide except for Japan (“Territory”).

ASP015K is a novel oral Janus Kinase (JAK) inhibitor which Astellas is developing for rheumatoid arthritis. In a 6-week Phase-IIa (Proof of Concept; POC) study of patients with psoriasis, ASP015K was well tolerated and demonstrated dose-dependent improvements in Psoriasis Areas Severity Index (PASI) change from baseline. Astellas is currently conducting 3 Phase-IIb studies in patients with rheumatoid arthritis in the U.S./Europe and Japan.

In return for the exclusive license to develop and commercialize ASP015K in the Territory, Astellas is entitled to receive an up-front payment of $65 million from Janssen. Astellas is also eligible to receive contingent milestone payments upon the achievement of certain development, regulatory and commercial milestones, which could total up to $880 million. Astellas is further entitled to receive double-digit royalty payments on net sales of ASP015K in the Territory from Janssen. After completion of the Phase IIb studies in the Territory, Janssen is responsible for all future costs associated with the development and commercialization of ASP015K for rheumatoid arthritis and other autoimmune indications in the Territory. Astellas will continue development and commercialization of ASP015K in Japan.

Astellas believes this transaction will maximize the value of ASP015K through the collaboration with Janssen which has a strong track record in the development and commercialization of leading products in the field of autoimmune diseases. It also strengthens our commitment to maximizing the enterprise value through optimization of R&D resources.

Upon the execution of the license agreement, Astellas will not revise its financial forecast for the current fiscal year (from April 1, 2012 to March 31, 2013).


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Astellas Pharma Inc.

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Posted: October 2012