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

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"), in the world.

TOKYO, Japan | Jan 24, 2007 |
Kirin Brewery Company, Limited ("Kirin"; Headquarters: Tokyo; President and COO: Kazuyasu Kato) and Astellas Pharma Inc. ("Astellas"; Headquarters: Tokyo; President and CEO: Masafumi Nogimori) 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"), in the world.

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 in stead of profit sharing.

Kirin has been creating and developing fully human antibody drugs using its unique TC MouseTM 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.

(Reference)
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 CD40L triggers immune reactions, and CD40 antagonistic mAb suppresses immune response by inhibition 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:
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. For more information on Kirin Brewery's Pharmaceutical Division, please visit its website at http://www.kirin.co.jp/english/index.html.

About Astellas:
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. The organization is committed to becoming a global 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 http://www.astellas.com.

SOURCE: Kirin Brewery Company, Limited

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