August 19, 2005

Takeda Pharmaceutical Company Limited

Takeda Obtained Approval of an Additional Indication of Premenopausal Breast Cancer for Leuplin® SR for Injection Kit 11.25

Osaka, Japan, August 19, 2005 − Takeda Pharmaceutical Company Limited ("Takeda") today announced that the additional indication of premenopausal breast cancer was approved for Leuplin® SR for injection kit 11.25 (generic name; leuprorelin acetate) on August 18 by the Japanese Ministry of Health and Welfare.

In addition, the adjuvant therapy for the prevention of recurrence after the surgical operation of premenopausal breast cancer was approved for this injection kit 11.25, and also for Leuplin® for injection 3.75 and Leuplin® for injection kit 3.75, both of which were already approved for the indication of premenpausal breast cancer.The dosage and administration of Leuplin® SR for injection kit 11.25 is once a twelve-week, and Leuplin® for injection 3.75 and Leuplin® for injection kit 3.75 are administered once a four-week.

There are several dosage and administration formulations for Leuplin®, and Leuplin® SR for injection kit 11.25 has been marketed for an indication of prostate cancer since 2002, and an application for the additional indication of premenopausal breast cancer was submitted in February 2004.

In Japan, the prevalence rate of breast cancer has been ranked top among all types of cancers since 1995 in the female*1, and the number of patients is estimated to further increase toward the future. In general, upon diagnosis of having breast cancer, the tumor are metastasized in many cases, and the number of fatality in 2004 was more than 10,000, which represented 8.4% of the total fatality due to malignant neoplasm^*2.

The approval of Leuplin® SR for injection kit 11.25 for this additional indicationis expected to contribute to the improvement of the QOL, alleviating the psychological burden with the less frequency of administration, of the patients with this cancer.

*1 Japanese Association of Cancer Registries
*2 Vital statistics of population, Japanese Ministry of Health and Welfare (2004)

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