Astellas Announces Acceptance of U.S. New Drug Application for Tacrolimus Extended Release Capsules

  Astellas Announces Acceptance of U.S. New Drug Application for Tacrolimus
                          Extended Release Capsules

PR Newswire

NORTHBROOK, Ill., Dec. 4, 2012

NORTHBROOK, Ill., Dec. 4, 2012 /PRNewswire/ -- Astellas Pharma US, Inc.
("Astellas"), a U.S. subsidiary of Tokyo-based Astellas Pharma Inc. (Tokyo:
4503), announced today that the U.S. Food and Drug Administration (FDA) has
accepted for review the company's New Drug Application (NDA) for tacrolimus
extended release capsules, for the prophylaxis of organ rejection in adult
kidney transplant recipients and adult male liver transplant recipients. Based
upon the September receipt of the NDA submission, the FDA Prescription Drug
User Fee Act (PDUFA) review date will be July 21, 2013.

"The NDA acceptance for tacrolimus extended release capsules marks an
important step toward addressing the unmet treatment need for transplant
recipients who have difficulty controlling their immunosuppression drug levels
with existing products," said Roy First, MD, Astellas Global Therapeutic Area
Head for Transplantation. "Astellas has been committed to the field of
immunology for more than 20 years and plans to continue that commitment by
working to bring promising new treatments for patients to market."

Developed by Astellas, tacrolimus extended release capsules are a once daily
formulation of the calcineurin-inhibitor immunosuppressant tacrolimus. The NDA
submission is based on six randomized and comparative studies of 2,842 (1,689
tacrolimus extended release) kidney transplant recipients and 689 (393
tacrolimus extended release) liver transplant recipients conducted in the
U.S., Canada, Europe, Australia, Brazil, New Zealand, among other sites.
Astellas also has more than five years of follow-up patient data from the
treatment of transplant recipients with tacrolimus extended release capsules.

Astellas was granted marketing approval for tacrolimus extended release
capsules under the trade name Advagraf^® in Europe in 2007 and under the trade
name Graceptor^® in Japan in 2008. In total, tacrolimus extended release
capsules have been approved for use in 69 countries resulting in more than
140,000 patient years of experience.

About Astellas

Astellas Pharma US, Inc., located in Northbrook, Illinois, is a US affiliate
of Tokyo-based Astellas Pharma Inc. Astellas 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 category leader in focused areas by
combining outstanding R&D and marketing capabilities. For more information
about Astellas Pharma US, Inc., please visit our website at www.Astellas.us or
www.AstellasTransplant.com.

Astellas is a recognized leader in transplantation and has been committed to
the field of immunology for more than 20 years. Dedicated to supporting the
advancement of care for patients, Astellas continues to build upon its legacy
and leadership in transplantation by investing in ongoing clinical research
and new product development.

SOURCE Astellas Pharma US, Inc.

Website: http://www.Astellas.us
Contact: Jenny M. Kite, Astellas, +1-847-682-4530, Jenny.Kite@Astellas.com; or
Katie Lowes, Edelman , +1-312-240-3345 , Katie.Lowes@Edelman.com