Tsumura & Co. (Headquarters: Tokyo, President: Junichi
Yoshii) announces that a meeting of its Board of Directors held on May 15,
2007 decided to discontinue development of TU-025 (Keishibukuryogan) in the
United States.
1. Description of the drug
TU-025 (Keishibukuryogan) is studied for the treatment of menopausal hot flashes.
2. Reason for discontinuation of development
The results of a phase II clinical trial conducted at the University of Minnesota
revealed a tendency for symptoms to improve with TU-025 compared with the placebo.
On the basis of these clinical results, Tsumura concluded that an additional
Phase II clinical study with a modified study design was necessary, and has
been preparing for that.
However, concerns arose that continuation of the development would prolong the
development period and the inevitably result in a cost increase. The Company
thus ultimately elected to discontinue development.
3. Future outlook
With development of TU-025 (Keishibukuryogan) to be discontinued, Tsumura will
concentrate on development of TU-100 (Daikenchuto), currently being studied in
the United States. The development schedule for TU-100 remains unchanged.
The impact of today's decision on the Company's medium-term outlook is slight.
The decision does not affect research or marketing of Kampo preparations in Japan.
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