Osaka, Japan, February 29, 2012 – Takeda Pharmaceutical Company Limited (“Takeda”) today announced that it has initiated enrollment of patients in Japan for two phase III clinical trials 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 analog 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 in about 100 countries 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 delayed-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 6 months, are currently available in markets such as the United States and Europe.

Two phase III clinical trials that have been started are multicenter, randomized, open-label, comparative studies, with patients with prostate cancer and those with premenopausal breast cancer. Each trial is planned to enroll approximately 160 patients to evaluate safety, efficacy, pharmacokinetics, and hormone dynamics of the medicine. The primary endpoints for prostate cancer is the suppression rate of serum testosterone to castrate level, and those for premenopausal breast cancer is the suppression rate of serum estradiol to menopausal level.

“The initiation of the phase III clinical trials of the Leuplin 6 month depot formulation in Japan is a significant step in the continued development of this important treatment that has made a difference in the lives of so many patients,” said Karen Ferrante, M.D., Chief Medical Officer, Millennium Pharmaceuticals, Inc. – the Takeda Oncology Company. “We continue to focus on the development of Leuplin, as well as TAK-700*, to strengthen our oncology product portfolio in hormone-dependent cancers.”

*TAK-700 is a selective, non-steroidal androgen synthesis inhibitor which targets 17, 20 lyase, a key enzyme in the production of steroidal hormones.