Evotec Starts Phase II Clinical Studies in Treatment-Resistant Depression
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Evotec AG / Evotec Starts Phase II Clinical Studies in Treatment-Resistant Depression processed and transmitted by Hugin AS. The issuer is solely responsible for the content of this announcement.
Hamburg, Germany - 1 July 2010: 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(at)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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Pdf of PressRelease: http://hugin.info/131215/R/1428277/376190.pdf
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Unternehmensinformation / Kurzprofil:
Datum: 01.07.2010 - 07:28 Uhr
Sprache: Deutsch
News-ID 23289
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