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Kirin and Astellas Enter Into Licensing Agreement on Immunosuppressive Fully Human Monoclonal Antibody

TOKYO, Jan 24, 2007 - (JCN Newswire) - Kirin Brewery Company, Limited and Astellas Pharma Inc. announced today that they have entered into a license and collaborative research and development agreement under which Kirin and Astellas will exclusively collaborate in developing and marketing a fully human anti-CD40 antagonistic monoclonal antibody ("CD40 antagonistic mAb") worldwide.

The immune system primarily serves to protect the body against infectious pathogens. This CD40 antagonistic mAb was discovered by Kirin and shows strong immunosuppressive activity in preclinical studies. The mechanism of action for CD40 antagonistic mAb is considered that it inhibits signal transduction between T-cell, playing main roles in immune response, and antigen-presenting cell. Although it is now under research and development for the first target indication of "prophylaxis of organ rejection associated with organ transplantation," it is also expected to be used for certain autoimmune diseases.

Under this agreement, Kirin will receive a certain upfront payment as well as milestone payments. Research and development will be carried out worldwide between Astellas and Kirin with equal cost sharing. On a worldwide basis, Astellas has a right to sell the product, and Kirin has a right to co-promote. Profit will be equally shared. With regard to Japan, Kirin retains a right to co-market; each party will pay to the other a certain royalty instead of profit sharing.

Kirin has been creating and developing fully human antibody drugs using its unique TCMouse(TM) Technology Platform, one of which is the CD40 antagonistic mAb. Immunological diseases are one of Kirin's focused targets, and Kirin will establish a product pipeline in the field of immunology starting with the CD40 antagonistic mAb. In addition, Kirin plans to establish worldwide capability of development and commercialization, and CD40 antagonistic mAb, through this collaboration with Astellas, is one of the products to carry out such strategy. Kirin believes CD40 antagonistic mAb contributes to medication for transplantation and autoimmune diseases.

Astellas has strong basis on transplantation field worldwide through the marketing of Prograf, an immunosuppressant discovered and developed by Astellas, for organ transplantation field in more than 70 countries. Astellas recognizes transplantations as a high prioritized category and through this collaboration with Kirin, will strengthen this field and will continue to contribute to transplantation medication.

This CD40 antagonistic mAb is an antibody which binds to CD40 expressed on antigen-presenting cell (APC). APC presents foreign substances' (antigens') information to T-cell which plays the main roles in immune response against foreign substances (antigens) when they enter the body. When T-cell interacts with APC and is activated, it triggers several immune reactions, including production of antibodies and cytokines, which exclude the pathogen or reject "non-self" graft from the body. CD40 ligand (CD40L) is expressed on T-cell and specifically binds to CD40. The binding of CD40 and CD40Ltriggers immune reactions, and CD40 antagonistic mAb suppresses immune response byinhibition of this binding of CD40 and CD40L. Furthermore, CD40, known to be expressed on B-cell and macrophage, plays the crucial role in the antibody production and inflammatory response, respectively. Thus, CD40 antagonistic mAb directly suppresses antibody production and inflammatory response.

About Kirin Pharmaceutical Division

Kirin Brewery's Pharmaceutical Division is committed to providing innovative pharmaceuticals to patients in the field of kidney diseases, cancer (including hematological disorders), immunological diseases, and infectious diseases by using its unique and strong biotechnology. Kirin Brewery's Pharmaceutical Division has established operations in Asian countries and will expand globally including North America and Europe as a specialty pharmaceutical company.

About Kirin Brewery Company, Limited

The Kirin Group brings together strong capabilities in each of its business areas, driven by an absolute commitment to customer focus and product quality. At Kirin we seek to remain closely in touch with our customers, earning the trust of the community at large through our dedication to product safety and the environment. And through the further development of meaningful CSR* activities such as those encouraging responsible drinking, we seek to build a sustainable future as a business group that delivers the happiness of food and health.

About Astellas Pharma Inc.

Astellas Pharma Inc., located in Tokyo, Japan, is a pharmaceutical company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products. In April 2005, the company was formed through the merger of Fujisawa Pharmaceutical Co., Ltd. and Yamanouchi Pharmaceutical Co., Ltd. The organization is committed to becoming a global mega pharmaceutical company by combining outstanding R&D and marketing capabilities and continuing to grow in the world pharmaceutical market. For more information on Astellas Pharma Inc., please visit the company's website at


Kirin Contact:

Kensuke Suzuki

Corporate Communications & IR Group

Kirin Brewery Company, Ltd.

Tel: +81-3-5540-3450

Astellas Contact:

Akihiro Tanaka, Ph.D.

VP, Corporate Communications

Astellas Pharma Inc.

Tel: +81-3-3244-3201

Posted: January 2007