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Evotec Reports Details of the Positive Proof-of-Concept Phase II Study in Insomnia With EVT 201
Date:9/5/2007

tion in TWT produced by EVT 201 was statistically significant for all hours of the night apart from hour 7 which came very close to reaching statistical significance (p= 0.058).

Commenting on the results, Dr John Kemp, Chief Research & Development Officer, Evotec AG, said: "I'm absolutely delighted with the results of this proof-of-concept Phase II study. The magnitude of effect on sleep maintenance appears more robust than those seen with other agents in similar cross-over design studies. In particular, we are not aware of similar studies that have demonstrated such statistically significant effects on Total Wake Time in the second half of the night and Total Wake Time each hour."

Jorn Aldag, President and Chief Executive Officer, Evotec AG, said: "Although certain aspects of insomnia are addressed by current treatments, there is no drug yet available which meets all the needs of insomnia patients. In our study EVT 201 demonstrated extremely robust findings on all key aspects of the problems faced by insomniacs, i.e. sleep onset and sleep maintenance and yet was without the patients feeling any drug hang-over effects after waking in the morning. We believe this gives EVT 201 a very competitive profile compared to the currently available insomnia treatments and to those in late stage clinical development."

Principal Investigator Dr James Walsh, Executive Director of the Sleep Medicine and Research Center, St John's Mercy Medical Center, Chesterfield, Missouri, US, said: "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. This together with robust effect sizes seen in this study, particularly with regard to sleep maintenance, offers considerable promise for the drug as a treatment for insomnia patients."

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SOURCE Evotec AG
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