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Evotec Reports Start of Phase II Proof-of-Concept Quit Rate Study
with EVT 302 and Results of Craving Study |
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Corporate news announcement processed and transmitted by Hugin ASA.
The issuer is solely responsible for the content of this
announcement.
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Hamburg, Germany - Evotec AG (Frankfurt Stock Exchange: EVT; NASDAQ:
EVTC) announced today the start of the Phase II proof-of-concept
study, investigating the effect of EVT 302 on the quit rate of
patients who want to stop smoking. The Company also provided an
analysis of the results of its exploratory Phase II craving study of
the same compound. EVT 302 is a reversible and highly selective
inhibitor of monoamine oxidase B (MAO-B).
The completed double-blind, placebo controlled, cross-over craving
study was designed to investigate the acute effect of EVT 302 alone
and in combination with nicotine replacement therapy (NRT) on craving
and withdrawal symptoms after short-term deprivation of cigarettes in
90 smokers. On the day before short-term abstinence from smoking,
smokers received either a single dose of EVT 302 or placebo matching
EVT 302. On the next day, at the start of the 12-hour smoking
deprivation phase, the subjects received additionally either NRT or
corresponding placebo (i.e. subjects received either placebo only, or
NRT only, or EVT 302 only, or NRT plus EVT 302). This was an
exploratory study to investigate a potential short-term role of MAO-B
inhibition in improving signs of withdrawal, but was also intended to
help the design of the Phase II proof-of-concept study, announced
today, on the absolute quit rate, the endpoint of clinical and
regulatory significance.
Results from the craving study confirmed that EVT 302 was well
tolerated in all patients. As expected, NRT reduced craving during
the period of abstinence more than placebo. EVT 302 alone showed no
acute effect on craving compared to placebo, and there was no
statistically significant difference between the combination of NRT
and EVT 302 and NRT alone. Regarding other withdrawal symptoms,
smoking cessation was associated with moderate deterioration in
psychomotor function & attention. The amelioration of this
deterioration by NRT was facilitated by EVT 302.
The just announced quit rate study is intended to provide the
proof-of-concept for the efficacy of EVT 302 in smoking cessation,
and, in addition, provide data on a potential useful interaction
between EVT 302 and NRT. In this multi-centre, double-blind, parallel
group design study, the effectiveness and safety of EVT 302 once
daily on its own and in combination with NRT compared to placebo will
be investigated in 400 smokers.
"We are pleased to announce the start of the Phase II quit rate study
following approvals by the Ethics Committee and by the German central
regulatory authority BfArM. Based on published research of other
MAO-B inhibitors in quit rate studies, we believe that EVT 302 will
improve quit rates in this longer term smoking cessation study and
plan to confirm initial signals for a potentially useful interaction
between EVT 302 and NRT," commented Dr Tim Tasker, Executive Vice
President Clinical Development at Evotec.
Contact: Anne Hennecke, Senior Vice President, Investor Relations &
Corporate Communications, Evotec AG, Phone: +49-40-56081-286,
anne.hennecke@evotec.com
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.
--- 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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