Translation
October 22, 2009
Name of listed company:
Taisho Pharmaceutical Co., Ltd. Code number:
4535 (1
st
Section of Tokyo Stock Exchange)
Head office:
24-1, Takada 3-Chome, Toshima-ku, Tokyo
CEO:
Akira Uehara
Inquiries to:
Masaki Tsuboi, General Manager,
Public Relations Section
Tel: +81-(0)3-3985-1115
Name of listed company:
Chugai Pharmaceutical Co., Ltd. Code number:
4519 (1
st
Section of Tokyo Stock Exchange)
Head office:
1-1, Nihonbashi-Muromachi 2-Chome, Chuo-ku, Tokyo
President: Osamu
Nagayama
Inquiries to:
Nobuyuki Chiba, General Manager,
Corporate Communications Dept.
Tel: +81-(0)3-3273-0881
New Drug Application Filed for Eldecalcitol,
An Active Vitamin D
3
Derivative
October 22, 2009 (Tokyo) - Taisho Pharmaceutical Co., Ltd. ("Taisho") [Head Office: Toshima-ku, Tokyo;
CEO: Akira Uehara] and Chugai Pharmaceutical Co., Ltd. ("Chugai") [Head Office: Chuo-ku, Tokyo;
President: Osamu Nagayama], announced today that a New Drug Application was filed to the Ministry of
Health, Labour and Welfare for the active vitamin D
3
derivative which was discovered by Chugai and
co-developed by the two companies for the indication of osteoporosis (generic name: eldecalcitol; Taisho
development code: CT-081, Chugai development code: ED-71).
It is estimated that 12 million people have osteoporosis in Japan. Treatments to increase bone density and
thus reduce the incidence of fractures are necessary since osteoporosis-related fractures reduce quality of
life, rendering patients bedridden and increase the risk of death. In the clinical trial, eldecalcitol was shown
to improve the bone and calcium metabolism, increase the bone density and inhibit fracture in the
osteoporosis patients. Therefore, it is expected that eldecalcitol will contribute to significantly improve the
quality of life of the patients.
Taisho and Chugai are determined to make efforts to realize early approval of eldecalcitol as a new active
vitamin D
3
derivative that enhances effect to bone, and supply to patients and healthcare professionals.
[ Reference: Outline of Phase III Clinical Study in Japan]
In Japan, a Phase III clinical study was performed in patients with osteoporosis as a randomized
double-blind alfacalcidol
*
-controlled study to assess efficacy and safety of eldecalcitol. A total of 1,087
patients were randomly assigned to the eldecalcitol treatment group and the alfacalcidol treatment group
and the incidence of new vertebral fractures in both groups was monitored for a period of three years. As
a result, patients receiving eldecalcitol showed a significantly lower incidence of bone fractures compared
to those receiving alfacalcidol, indicating that eldecalcitol is superior in preventing fractures. The safety
profile was similar to that of alfacalcidol, and nothing irregular was observed. * Alfacalcidol is an active vitamin D
3
prodrug (Chugai brand name: Alfarol
®
) used in Japan to treat
osteoporosis.