Evotec AG / Evotec Starts Phase II Clinical Studies in Treatment-Resistant Depression
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Hamburg, Germany – 1 July2010: Evotec AG (Frankfurt Stock Exchange: EVT, TecDAX) today
announced the start of the proof-of-concept Phase II study in treatment-resistant
depression with its NR2B subtype selective NMDA receptor antagonist EVT 101. This
clinical development is part of an alliance between Evotec and Roche (SIX: RO, ROG;
OTCQX: RHHBY).
The proof-of-concept Phase II study with EVT 101, which is being conducted in the United
States, has the main objective of studying the safety and tolerability of EVT 101 while
also exploring the efficacy of this intervention. Approximately 100 patients suffering
from treatment-resistant depression will participate in it. Treatment-resistance of
patients will be confirmed in a 6-week prospective antidepressant treatment phase
preceding the actual 4-week double-blind treatment.
Treatment-resistance to antidepressant drugs is observed in up to 30% of depressed
patients. NMDA receptor antagonists represent an alternative mechanism that has the
potential to improve depression in patients resistant to conventional antidepressants.
Dr Werner Lanthaler, Chief Executive Officer of Evotec AG, commented: “The clinical
development of EVT 101 is addressing an area of significant unmet medical need, and this
development represents a big market opportunity. We are happy to have Roche, as a
recognised pioneer for novel solutions in the CNS area, for this development with us.”
About NMDA receptors in treatment-resistant depression
NMDA receptors are involved in the pathology of depression. NR2B-selective antagonists
bind preferentially to the activated form of the NMDA receptor containing the NR2B
subunit and allosterically modulate, in an activity-dependent manner, channel activity
by inhibiting channel opening probability. They show advantages over non-selective NMDA
antagonists due to greater separation of efficacy from side effects. The non-selective
NMDA receptor blocker ketamine and an NR2B-selective NMDA antagonist have shown in
exploratory clinical trials the potential to provide clinical benefit for patients with
treatment-resistant depression. However, both molecules, for which proof of concept has
been shown before, require parenteral administration, hence an orally active therapeutic
option is needed. EVT 101 is an orally available compound which is well tolerated at
dose levels considered to reach CNS levels which go along a high NMDA receptor
occupancy. In a Phase I fMRI study performed with EVT 101 pharmacodynamic effects were
seen at exposures similar to those planned for the ongoing proof of concept study.
About Evotec & Roche Alliance
Evotec has entered an alliance with Roche for Phase II clinical development of EVT 101
in patients with treatment-resistant depression. The potential value of this transaction
exceeds USD 300 million. Evotec is responsible for conducting Phase II studies for EVT
101, a compound originally discovered by Roche and developed from discovery stages
through clinical studies by Evotec. Within this alliance, Evotec has conducted the first
Phase I safety and tolerability study for EVT 103, a next generation compound to EVT
101. Roche fully funds these development programmes.
Contact: Dr Werner Lanthaler, Chief Executive Officer,
Evotec AG, Tel.: +49.(0)40.56081-242, werner.lanthaler@evotec.com
mailto:werner.lanthaler@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 2010
financial outlook and our expected financial results in future quarters, our ability to
deliver on our liquidity guidance, our belief that we are on course to profitability in
2012, our expectations and assumptions concerning regulatory, clinical and business
strategies, the progress of our clinical development programmes and timing of the
commencement and 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; the risk that we will not
achieve the anticipated benefits of our collaborations, partnerships and acquisitions in
the timeframes expected, or at all; 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; the risk that 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 most recent 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.
HUG#1428277
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Evotec AG
Schnackenburgallee 114 Hamburg Germany
WKN: 566480;ISIN: DE0005664809;
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