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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

Phase II trial with EVT 201 is particularly encouraging as elderly patients are particularly underserved by current treatments. The study's confirmation of our earlier Phase II data in adults underscores the finding that EVT 201 has hypnotic efficacy in both adults and elderly primary insomniacs and we believe that these data make EVT 201 an extremely attractive partnering opportunity."

"We now have two sets of data which robustly demonstrate the same profile of EVT 201 in both adults and the elderly - effects upon sleep onset and sleep maintenance throughout the night with minimal residual effects. This is exceptional for a compound at this stage of development", added Dr Tim Tasker, Executive Vice President Clinical Development, Evotec AG. "The results also show that elderly patients with insomnia and daytime sleepiness were significantly less sleepy during the day following seven nights treatment measured using the objective MSLT test. The size of this effect was clinically significant, and has not been demonstrated in other recent hypnotic studies. This exciting headline finding will now be fully investigated in further analysis of the 2005 data."

Principal Investigator Dr James Walsh, Executive Director of the Sleep Medicine and Research Center, St John's Mercy Medical Center, Chesterfield, Missouri, US, said: "In this second Phase II study with EVT 201 the robust efficacy seen previously in the adult population was duplicated with the same doses in elderly insomnia patients. It is exciting that the sleep-promoting effects seen throughout the night, coupled with no significant sedative activity of the drug during the daytime, allowed the improvement of sleep to be accompanied by significantly improved alertness during the day. This combination gives the compound a very attractive profile as a sleep promoting agent which improves both night-time and daytime symptoms of insomnia in the elderly."

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