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Evotec Reports Positive Top-Line Results in Phase II Study With EVT 201 in Elderly Insomniacs With Daytime Sleepiness
Date:10/16/2007

as well tolerated. No serious treatment emergent adverse events were reported during the study. The majority of adverse events reported were mild and infrequent. The most common adverse events were dizziness, headache and somnolence and the percentage of patients reporting these events is shown in the table below:

Treatment emergent Placebo EVT 201 EVT 201

adverse events

1.5 mg 2.5 mg

(n=44) (n=53) (n=52)

Dizziness 0 5.7% 9.6%

Headache 0 9.4% 5.8%

Somnolence 2.3% 1.9% 11.5%

No significant difference was seen between either dose of EVT 201 and placebo in the Benzodiazepine Withdrawal Questionnaire.

The results of this study confirm the effects of EVT 201 on sleep onset and sleep maintenance seen in the adult population in Study 2004 and indicate that the same doses 1.5 mg and 2.5 mg have hypnotic efficacy in the elderly with no significant residual effects.

Further analysis of the remaining secondary and exploratory endpoints is ongoing.

"We're delighted that these results in elderly insomniacs again confirm the excellent profile of EVT 201 as a potential treatment that helps patients to fall asleep quickly, maintains their sleep throughout the night and yet enables them to wake in the morning without hangover effects and feeling like they've had a good night's sleep," said Dr John Kemp, Chief Research & Development Officer, Evotec AG. "Due to its partial positive allosteric modulation of GABAA receptors, EVT 201 provides a novel approach to the treatment of insomnia, yet since the GABAA system is a well understood pathway, the risk of unexpected side effect findings are low compared to completely novel mechanisms."

Jorn Aldag, President and Chief Executive Officer, Evotec AG, said: "The positive outcome of this second clinical
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SOURCE Evotec AG
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