Astellas Announces Application for the Immunosuppressant FK506 Modified Release Formulation in Japan

Tokyo, Japan, May 30, 2006 - (JCN Newswire) - Astellas Pharma Inc. (TSE: 4503) today announced that it has submitted an application for the market authorization for the immunosuppressant FK506 Modified Release Formulation (generic name: tacrolimus) to the Pharmaceuticals and Medical Devices Agency (PMDA) with the proposed indication of "suppression of organ rejection in organ transplantation" and "suppression of graft rejection and GVHD in bone marrow transplantation" on May 29, 2006 in Japan.Tacrolimus is an immunosuppressant discovered and developed by Astellas and is marketed as an immunosuppressant for organ transplantation under the brand name Prograf(R) in more than 70 countries. Since FK506 Modified Release Formulation is a once-daily oral formulation of tacrolimus, patients' compliance is expected to be improved compared to twice a day with the conventional formulation. The FK506 modified release formulation is therefore expected long term graft protective effect. In addition, this formulation is expected to be at least as safe as the conventional formulation since peak blood concentrations can be controlled at lower or even levels.As far as FK506 Modified Release Formulation is concerned, Astellas submitted a New Drug Application (NDA) in the US and a Marketing Authorization Application (MAA) in Europe, respectively, prior to the Japanese application.
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 www.astellas.com. Contact: Astellas Pharma Inc.
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