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Evotec AG (DE) - Evotec Reports Positive Proof-of-Concept Top-Line,Results with ...

ronic insomnia for further differentiation is ongoing. Top-line results from this trial are expected to be announced by Q4 2007 / Q1 2008.

Study design This US, multi-centre, double-blind trial was designed to evaluate the efficacy of EVT 201 in a three way cross-over design in 67 patients with primary insomnia. Patients were screened for entry into the study and the eligibility criteria included: a diagnosis of primary insomnia according to DSM (Diagnostic and Statistical Manual of Mental Disorders) IV; mean LPS > 20 minutes, mean WASO ³ 40 minutes, mean TST 240-420 minutes, all determined during two consecutive nights PSG evaluation. Patients received two dose levels of EVT 201 and placebo, in a random order, for two consecutive nights with a 5-12 day washout between each period. The primary endpoints of this trial were to assess Wake After Sleep Onset (WASO) as well as Total Sleep Time (TST) determined by polysomnography (PSG). The secondary endpoints included additional PSG-based measures such as latency to persistent sleep, number of awakenings and effects on sleep architecture. In addition, patients evaluated sleep quality and quantity. Residual sedation was assessed by the Digit Symbol Substitution Test (DSST) and a categorical patient rating. Safety measures included adverse events and laboratory data.

Conference call Evotec will hold a conference call today at 4.00 pm CET (3.00 pm GMT/10.00 am US time East Coast) to discuss the top-line results.

Conference call numbers (listen only): Europe: +49.(0)69.5007 1309 (Germany) +44.(0)20.7806 1955 (UK) US: +1.718.354 1388 Webcast: www.evotec.com

The presentation slides are available via the webcast.

A replay of the conference call will be available for 24 hours and can be accessed in Europe by dialing +49.(0)69.22222 0418 (Germany) or +44.(0)20.7806 1970 (UK) and in the US by +1.718.354 1112. The access code is 1624428#.
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