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Bankleitzahlen - online.de


Evotec's EVT 101 Well Tolerated in Four Week Higher Repeat Dose Safety Study

Corporate news announcement processed and transmitted by Hugin ASA.
The issuer is solely responsible for the content of this
announcement.
----------------------------------------------------------------------
--------------




Hamburg, Germany - Evotec AG (Frankfurt Stock Exchange: EVT; NASDAQ:
EVTC) announced today top-line results of a double-blind, 4-week
Phase Ib study with EVT 101, an orally active NR2B-subtype selective
antagonist of NMDA receptors with potential in Alzheimer's disease,
neuropathic pain and other indications. The study showed in both
young and elderly subjects that the drug was well tolerated up to the
highest dose tested.

The study was designed to evaluate safety/tolerability,
pharmacokinetics, and pharmacodynamics during prolonged dosing with
EVT 101 as compared to placebo, but at higher dose levels and for a
longer duration that the previously completed Phase I study. The
study was conducted and completed as planned per protocol.

EVT 101 was administered to 48 young and elderly healthy subjects
over four weeks. Up to the highest dose level (12 mg/day in elderly,
15 mg/day in young subjects) EVT 101 was well tolerated by both
populations. No severe or serious adverse events were reported, and
only few transient, mostly mild, adverse events occurred. This safety
and tolerability profile is extremely encouraging as the doses
evaluated are predicted to be well into the anticipated therapeutic
range. As previously reported (see press release, March 28, 2008),
this trial contained a sub-study in which drug CSF levels were
measured to determine the extent of brain penetration.

Psychometric tests, examining different aspects of cognitive
function, revealed a mixed pattern of minor transient changes, as
expected from populations of healthy subjects performing optimally in
cognitive tasks.

"Together with results from the fMRI brain imaging which we announced
in March, these results provide a robust Phase Ib package. We have
found doses of this highly specific compound that achieve a high
level of brain exposure to achieve a high level of NR2B receptor
blockade. These doses produce specific modulation of relevant brain
areas and, importantly, are also well tolerated. This provides a good
foundation for moving forward with the clinical development of this
compound and enables us to investigate EVT 101 in relevant patient
groups," commented Dr Tim Tasker, Executive Vice President Clinical
Development, Evotec AG.


Forward-Looking Statements
Information set forth in this press release contains forward-looking
statements, which involve a number of risks and uncertainties. Such
forward-looking statements include, but are not limited to,
statements about our expectations and assumptions concerning
regulatory, clinical and business strategies, the progress of our
clinical development programs and timing of the results of our
clinical trials, strategic collaborations and management's plans,
objectives and strategies. These statements are neither promises nor
guarantees, but are subject to a variety of risks and uncertainties,
many of which are beyond our control, and which could cause actual
results to differ materially from those contemplated in these
forward-looking statements. In particular, the risks and
uncertainties include, among other things: risks that product
candidates may fail in the clinic or may not be successfully marketed
or manufactured; risks relating to our ability to advance the
development of product candidates currently in the pipeline or in
clinical trials; our inability to further identify, develop and
achieve commercial success for new products and technologies;
competing products may be more successful; our inability to interest
potential partners in our technologies and products; our inability to
achieve commercial success for our products and technologies; our
inability to protect our intellectual property and the cost of
enforcing or defending our intellectual property rights; our failure
to comply with regulations relating to our products and product
candidates, including FDA requirements; the risk that the FDA may
interpret the results of our studies differently than we have; the
risk that clinical trials may not result in marketable products; the
risk that we may be unable to successfully secure regulatory approval
of and market our drug candidates; and risks of new, changing and
competitive technologies and regulations in the U.S. and
internationally.
The list of risks above is not exhaustive. Our Annual Report on Form
20-F, filed with the Securities and Exchange Commission, and other
documents filed with, or furnished to the Securities and Exchange
Commission, contain additional factors that could impact our
businesses and financial performance. We expressly disclaim any
obligation or undertaking to release publicly any updates or
revisions to any such statements to reflect any change in our
expectations or any change in events, conditions or circumstances on
which any such statement is based.

Contact: Anne Hennecke, Senior Vice President, Investor Relations &
Corporate Communications, Evotec AG, Phone: +49-40-56081-286,
anne.hennecke@evotec.com



--- End of Message ---

Evotec AG
Schnackenburgallee 114 Hamburg Germany

WKN: 566480; ISIN:
DE0005664809 ; Index: Prime All Share, CDAX, HDAX, MIDCAP, TECH All
Share;
Listed: Geregelter Markt in Frankfurter Wertpapierbörse, Prime
Standard in Frankfurter Wertpapierbörse,
Freiverkehr in Börse Berlin, Freiverkehr in Bayerische Börse München,

Freiverkehr in Börse Düsseldorf, Freiverkehr in Börse Stuttgart,

Freiverkehr in Hanseatische Wertpapierbörse zu Hamburg, Freiverkehr
in Niedersächsische Börse zu Hannover;
Copyright © Hugin AS 2008. All rights reserved.



 
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