Evotec starts Phase I with EVT 103, an NR2B-selective NMDA receptor
antagonist
(Thomson Reuters ONE) - Corporate news announcement processed and transmitted by Hugin AS.The issuer is solely responsible for the content of this announcement. ------------------------------------------------------------------------------------ Hamburg, Germany - Evotec AG (Frankfurt Stock Exchange: EVT; NASDAQ:EVTC) announced today the Phase I clinical study initiation for EVT103, a small molecule NR2B-selective NMDA receptor antagonist. EVT103 is a next generation molecule following EVT 101, the orallyavailable compound currently planned to enter clinical developmentfor treatment-resistant depression in collaboration with Roche.The first-in-human Phase I study is a double-blind,placebo-controlled, randomized ascending dose study in healthy youngmale subjects. The endpoints of the study are safety, tolerability,pharmacokinetic profile and pharmacodynamic effects after oral singleand multiple dose administration. In addition food interaction willbe investigated.The non-selective NMDA receptor blocker ketamine and anothercompound, an NR2B-selective NMDA antagonist, have been proven toprovide substantial clinical benefit for patients withtreatment-resistant depression. However, both molecules, for whichproof of concept has been shown before, require parenteraladministration, hence an orally active therapeutic option is needed.Dr Werner Lanthaler, Chief Executive Officer of Evotec, commented:"The development of EVT 103 is part of the alliance between Evotecand Roche to develop therapeutic options for patients withtreatment-resistant depression, an area of high unmet medical need.EVT 103 is a compound which belongs to the next generation ofmolecules, is expected to show even better tolerability compared toEVT 101, thus reducing the risk for a successful programmedevelopment of an orally available selective NMDA antagonist, and apotential application in also other areas of high unmet medicalneed."About NMDA receptors:NMDA receptors are involved in the pathology of depression.NR2B-selective antagonists bind preferentially to the activated formof the NMDA receptor containing the NR2B subunit and allostericallymodulate, in an activity-dependent manner, channel activity byinhibiting channel opening probability. They show advantages overnon-selective NMDA antagonists due to greater separation of efficacyfrom side effects.Terms of the Agreement with Roche:Evotec has entered an alliance with Roche with the potential value ofthis transaction exceeding USD 300 million. Evotec is responsible forconducting Phase II clinical development of EVT 101 in patients withtreatment-resistant depression, a compound originally discovered byRoche and developed from discovery stages through clinical studies byEvotec. Within this alliance, Evotec will also conduct Phase I safetyand tolerability studies for EVT 103, a next generation compound toEVT 101. Roche will fully fund these development programs.Contact: Dr Werner Lanthaler, Chief Executive Officer,Evotec AG, Tel.: +49.(0)40.56081-242, werner.lanthaler(at)evotec.comForward-looking statementsInformation set forth in this press release contains forward-lookingstatements, which involve a number of risks and uncertainties. Suchforward-looking statements include, but are not limited to,statements about our expectations and assumptions concerningregulatory, clinical and business strategies, the progress of ourclinical development programs and timing of the results of ourclinical trials, strategic collaborations and management's plans,objectives and strategies. These statements are neither promises norguarantees, but are subject to a variety of risks and uncertainties,many of which are beyond our control, and which could cause actualresults to differ materially from those contemplated in theseforward-looking statements. In particular, the risks anduncertainties include, among other things: risks that the Company maybe unable to reduce its cash burn through recent restructuring andcost containment measures and may not recognize the results of suchmeasures within the expected timeframe; risks that product candidatesmay fail in the clinic or may not be successfully marketed ormanufactured; the risk that we will not achieve the anticipatedbenefits of our collaborations, partnerships and acquisitions in thetimeframes expected, or at all; risks relating to our ability toadvance the development of product candidates currently in thepipeline or in clinical trials; our inability to further identify,develop and achieve commercial success for new products andtechnologies; the risk that competing products may be moresuccessful; our inability to interest potential partners in ourtechnologies and products; our inability to achieve commercialsuccess for our products and technologies; our inability to protectour intellectual property and the cost of enforcing or defending ourintellectual property rights; our failure to comply with regulationsrelating to our products and product candidates, including FDArequirements; the risk that the FDA may interpret the results of ourstudies differently than we have; the risk that clinical trials maynot result in marketable products; the risk that we may be unable tosuccessfully secure regulatory approval of and market our drugcandidates; and risks of new, changing and competitive technologiesand regulations in the U.S. and internationally.The list of risks above is not exhaustive. Our most recent AnnualReport on Form 20-F, filed with the Securities and ExchangeCommission, and other documents filed with, or furnished to theSecurities and Exchange Commission, contain additional factors thatcould impact our businesses and financial performance. We expresslydisclaim any obligation or undertaking to release publicly anyupdates or revisions to any such statements to reflect any change inour expectations or any change in events, conditions or circumstanceson which any such statement is based.http://hugin.info/131215/R/1340069/320144.pdf --- End of Message ---Evotec AGSchnackenburgallee 114 Hamburg GermanyWKN: 566480; ISIN: DE0005664809 ; Index: Prime All Share, CDAX, HDAX, MIDCAP, TECH All Share;Listed: 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, Regulierter Markt in Frankfurter Wertpapierbörse;
Datum: 08.09.2009 - 08:01 Uhr
Sprache: Deutsch
News-ID 5578
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