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MAR 7,2006

Results of phase-III clinical studies
of an anti-Parkinson’s disease
drug Istradefylline(KW-6002)
conducted overseas

 Kyowa Hakko Kogyo Co., Ltd. located in Chiyoda-ku, Tokyo, Japan (President: Dr. Yuzuru Matsuda) has completed three Phase III clinical studies of KW-6002 (Generic (INN) name: Istradefylline), an agent developed in-house for the treatment of Parkinson's Disease.

 Parkinson's Disease is initiated by a shortage of the neurotransmitter dopamine in the brain, which causes an imbalance in the nervous system. This disease is treated mainly by dopamine replacement with L-DOPA. Long term therapy with L-DOPA is associated with the development of a shortening response to each dose. This is called "wearing-off phenomenon."

 The three Phase III clinical studies were conducted in Parkinson's Disease patients with "wearing-off phenomenon" on treatment with L-DOPA alone or L-DOPA administered concomitantly with other Parkinson's Disease medications. Two studies were conducted in North America and one study was conducted in 14 countries of the EU and other regions. In all three studies, the efficacy and safety of Istradefylline(KW-6002) were assessed. Istradefylline(KW-6002) was administered for 12-16 weeks. The primary endpoint was reduction in the percentage of awake time spent in the "off" state, and it served as an indicator of the improvement in the "wearing-off phenomenon."

 One of the North American studies revealed a statistically significant reduction in the percentage of awake time spent in the "off" state. The other North American study and the trial conducted in the EU and other regions did not demonstrate a significant reduction in percentage of awake time per day spent in the "off" state compared with placebo patients, but showed a significant improvement or a trend toward improvement in one of the secondary endpoints, the motor function score, assessed using the Unified Parkinson's Disease Rating Scale (UPDRS) subscore III. Istradefylline(KW-6002) showed a similar safety profile as previously reported in Phase II studies. Based on these results, together with the results of the Phase IIb program (also demonstrating a statistically significant reduction in the percentage of awake time per day spent in the off state), Kyowa Hakko intends to submit a New Drug Application (NDA) to the United States Food and Drug Administration (FDA) in the latter half of this year.

 Istradefylline(KW-6002) has a specific antagonistic effect on the adenosine A2A receptor in the brain. This compound is expected to be a novel antiparkinson's drug and to contribute to relieving various symptoms in many patients with Parkinson's Disease.



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