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Takeda Submits a New Drug Application for Leuplin® 6 Month Depot in Japan for the Treatment of Prostate Cancer and Premenopausal Breast Cancer

September 5, 2014

Osaka, Japan, September 5, 2014 – Takeda Pharmaceutical Company Limited (“Takeda”) announced today that it has submitted a New Drug Application ("NDA") to the Japanese Ministry of Health, Labour and Welfare for "Leuplin ®" 6 month depot (generic name: leuprorelin acetate, hereafter "Leuplin"), a treatment for prostate cancer and premenopausal breast cancer.

Created and developed by Takeda, Leuplin is an LH-RH agonist that consistently stimulates the pituitary gland, resulting in suppressed production of male/female hormone. Leuplin is used as a treatment for hormone-dependent diseases such as prostate cancer and premenopausal breast cancer, and it is currently available worldwide.

Leuplin was initially launched as a once-daily administration by injection, and Takeda has applied multiple innovations, based on its expertise in drug formulation technology, to turn it into a sustained-release microcapsule depot formulation, enabling to maintain stable blood concentration levels over a long period of time. At present, both 1 month and 3 month formulations have been approved and are marketed in Japan. With the application of further technological breakthrough, the 6 month depot, which enabled the treatment with one administration at every 24 weeks, are currently available in markets such as the United States, Europe and some countries in Asia.

This submission is based on the results of two clinical phase III studies in patients with prostate cancer and those with premenopausal breast cancer through multicenter, randomized, open label, comparative studies, evaluating the safety, efficacy, pharmacokinetics, hormone dynamics and others. 6M depot becomes the world's first submission for the treatment of premenopausal breast cancer.

By delivering this new treatment for both prostate cancer and premenopausal breast cancer through our innovative drug delivery system, we look forward to further contributing to improving the quality of life (QOL) of patients and meeting the needs of healthcare professionals.