Evotec Reports Good Progress in Product Development in Treatment-Resistant Depression in its Alliance with Roche
(Thomson Reuters ONE) -
Evotec AG / Evotec Reports Good Progress in Product Development in Treatment-Resistant Depression in its Alliance with Roche processed and transmitted by Hugin AS. The issuer is solely responsible for the content of this announcement.
* Successful completion of first-in-man study with EVT 103
* Positive feedback from the FDA to initiate Phase II with EVT 101
Hamburg, Germany - 10 March 2010: Evotec AG (Frankfurt Stock Exchange: EVT,
TecDAX) today announced two positive aspects that strengthen its integrated
product development in treatment-resistant depression in its strategic alliance
with Roche.
Evotec AG completed the clinical part of the first Phase I study with its
NR2B-selective NMDA receptor antagonist EVT 103. EVT 103 is a small molecule
drug candidate intended for oral use in conditions such as treatment-resistant
depression, but potentially also other CNS indications.
The first-in-human Phase I study was a double-blind, placebo-controlled,
randomised ascending dose study in 72 healthy young male subjects. The endpoints
of the study were safety, tolerability and pharmacokinetic profile after oral
single and multiple dose administration. In addition, the effect of food on the
pharmacokinetics of EVT 103 was investigated. The compound was safe and very
well tolerated, with excellent bioavailability and only a minimal effect of food
on the kinetic profile.
In addition, for its NMDA receptor antagonist EVT 101, which is the lead
compound in the strategic alliance with Roche in treatment-resistant depression,
the FDA has allowed Evotec to proceed with the initiation of a Proof-of-Concept
study. The study will start recruiting patients in Q2.
"We are glad that we received positive feedback from the FDA regarding the
toxicology and safety aspects of the planned Proof-of-Concept study with EVT
101. In addition, the Phase I results of EVT 103 now make this a very strong
programme for a clinical product development in treatment-resistant depression",
said Dr Werner Lanthaler, Chief Executive Officer of Evotec.
Contact Evotec AG:
Dr Werner Lanthaler, Chief Executive Officer, Phone: +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 expectations
and assumptions concerning our strategic collaborations, our regulatory,
clinical and business strategies, the progress of our clinical development
programmes 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#1392246]
--- End of Message ---
Evotec AG
Schnackenburgallee 114 Hamburg Germany
WKN: 566480;ISIN: DE0005664809 ;Index:Prime All Share,CDAX,TECH All Share,MIDCAP,HDAX;
Listed: Freiverkehr in Börse Stuttgart,
Freiverkehr in Hanseatische Wertpapierbörse zu Hamburg,
Freiverkehr in Börse Berlin,
Freiverkehr in Börse Düsseldorf,
Freiverkehr in Bayerische Börse München,
Freiverkehr in Niedersächsische Börse zu Hannover,
Prime Standard in Frankfurter Wertpapierbörse,
Regulierter Markt in Frankfurter Wertpapierbörse;
PDF of Press Release: http://hugin.info/131215/R/1392246/349858.pdf
Themen in dieser Pressemitteilung:
Unternehmensinformation / Kurzprofil:
Datum: 10.03.2010 - 01:30 Uhr
Sprache: Deutsch
News-ID 1011124
Anzahl Zeichen: 0
contact information:
Contact person:
Town:
Hamburg
Phone:
Kategorie:
Business News
Anmerkungen:
Diese Pressemitteilung wurde bisher 86 mal aufgerufen.
Die Pressemitteilung mit dem Titel:
"Evotec Reports Good Progress in Product Development in Treatment-Resistant Depression in its Alliance with Roche
"
steht unter der journalistisch-redaktionellen Verantwortung von
Evotec AG (Nachricht senden)
Beachten Sie bitte die weiteren Informationen zum Haftungsauschluß (gemäß TMG - TeleMedianGesetz) und dem Datenschutz (gemäß der DSGVO).
