Kyowa Hakko Kogyo Completes Overseas Phase III Clinical Trials for KW-6002, Anti-Parkinson's Disease Agent.

Tokyo, Japan, Mar 8, 2006 - (JCN) - Kyowa Hakko Kogyo has completed three phase III clinical trials for KW-6002, its investigational drug for treating Parkinson's disease; two were conducted in North America and one in Europe. KW-6002 is a promising agent that selectively antagonizes the adenosine A2A receptor.

The trials covered Parkinson's disease patients with the wearing-off phenomenon, who have received the treatment with L-DOPA alone or L-DOPA with other agents. The primary endpoint is the reduction in the percentage of off state when the subjects awake while the secondary endpoint is the improvement of the Unified Parkinson's Disease Rating Scale (UPDRS) subscore III.

As for the primary endpoint, only one trial in North America showed preferable results. However, all trials showed a significant improvement or a trend toward improvement in UPDRS.

Going forward, Kyowa Hakko Kogyo plans to file a new drug application with the US Food and Drug Administration in late 2006.

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