To Whom It May Concern:

October 20, 2014

Company Name: Taisho Pharmaceutical Holdings Co., Ltd. Head Office: 3-24-1, Takada, Toshima-ku, Tokyo Representative: Akira Uehara, President and CEO

(First Section of TSE: Code 4581) Contact: Makoto Funahashi, General Manager

Corporate Communications

(Tel: +81-3-3985-1115)

Filing for Manufacturing and Marketing Approval in Japan for TT-063 Anti-inflammatory Analgesic Patch Formulation Containing S-Flurbiprofen

Taisho Pharmaceutical Holdings Co., Ltd. has announced that its consolidated subsidiary Taisho Pharmaceutical Co., Ltd. ("Taisho Pharmaceutical") [Head Office: Toshima-ku, Tokyo, President: Shigeru Uehara] filed today for manufacturing and marketing approval for the
anti-inflammatory analgesic patch formulation containing S-flurbiprofen (Development Code: TT-063) from the Ministry of Health, Labour and Welfare for the indication of osteoarthritis.
TT-063 is an anti-inflammatory analgesic patch formulation containing S-flurbiprofen created by consolidated subsidiary TOKUHON Corporation [Head Office: Toshima-ku, Tokyo; President: Jun-ichi Fukudome], which Taisho Pharmaceutical subsequently joined to co-develop.
In phase 3 clinical trials targeting 633 Japanese patients with osteoarthritis of the knee joint, two groups of patients were compared: a group of patients to whom TT-063 was administered and a group of patients to whom a flurbiprofen gel patch was administered as a control drug. As a result,
TT-063 was found to demonstrate efficacy relative to the control drug, in terms of the study's
primary endpoint. In regard to the safety profile, the study did not find any events that would pose a clinical safety issue. A one-year long-term drug administration study targeting osteoarthritis patients was also carried out. It did not find any events that would pose a clinical safety issue.
Osteoarthritis is a chronic degenerative disease of the joints, mainly involving degeneration and abrasion of joint cartilage. It is classified into osteoarthritis of the knee joint, lumbar spondylosis and other conditions depending on the affected area. The number of patients in Japan is estimated to be 24 million for osteoarthritis of the knee joint and 35 million for lumbar spondylosis, with approximately 30% of these patients showing symptoms of pain. Considering that pain is a major cause of reduced quality of life (QOL), there are high hopes for the development of drugs that possess a powerful anti-inflammatory analgesic action.
Through research and development into TT-063, the Taisho Pharmaceutical Group hopes to provide more patients with a treatment option and, at the same time, play a part in extending healthy life expectancies.

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