MediGene AG Decides on a Revision of the Development Plans for
EndoTAG(TM)-1 and RhuDex(TM), and Dow
(Thomson Reuters ONE) - Corporate news announcement processed and transmitted by Hugin AS.The issuer is solely responsible for the content of this announcement. ------------------------------------------------------------------------------------ Martinsried/Munich, December 11, 2009.Today the Executive andSupervisory Boards of MediGene AG approved the company's futurebusiness plan. Among other things, this business plan includes thefollowing changes:MediGene has decided to develop the manufacturing process for itsdrug candidate EndoTAG(TM)-1 to marketability prior to the start ofthe planned clinical phase III trial. This implies the change fromthe freeze-drying process which has been applied for manufacturingclinical trial material up to now to a spray drying process whichwill significantly reduce the future manufacturing costs forEndoTAG(TM)-1. This means that the initiation of the phase III trialwill be postponed by approx. six months to the first half of 2011.The overall duration of the development process remains unaffected bythis, as the change in the production process will take place at anearlier date than originally scheduled. Later proof of comparabilitywill be obsolete in the new scheme.For the drug candidate RhuDex(TM) the new development plan providesfor further preclinical trials in 2010 in order to specify thetherapeutic window, thus optimizing the clinical development program.MediGene is planning to resume clinical development in the fourthquarter of 2010, or in the first quarter of 2011, which means apostponement by approx. one year.In addition the Supervisory Board of MediGene AG has decided todownsize the company's Executive Board to two persons. Dr. FrankMathias will assume direct responsibility for the Research &Development sector. In the course of this, the previous ExecutiveBoard member for Research & Development, Dr. Axel Mescheder, leavesMediGene.Prof. Dr. Ernst-Ludwig Winnacker, Chairman of the Supervisory Boardand Co-founder of MediGene AG, comments: "Over the past 6 years Dr.Axel Mescheder has made a significant contribution to MediGene's drugpipeline, at first in his position as Head of Clinical Development,and since May 2008 as Chief Scientific Officer & Chief DevelopmentOffice. On behalf of the Executive and Supervisory Boards of MediGeneAG, I herewith express my sincerest thanks for this invaluablecontribution which will provide a basis for the further developmentof our drug candidates."Details of the future MediGene business plan will be disclosed on theoccasion of the analyst conference which will be held in Frankfurt onTuesday, December 15, 2009. This conference will be webcast atwww.medigene.com. The agenda may be accessed at www.medigene.com.This press release contains forward-looking statements representingthe opinion of MediGene as of the date of this release. The actualresults achieved by MediGene may differ significantly from thestatements made herein. MediGene is not bound to update any of theseforward-looking statements. MediGene® and EndoTAG(TM) areregistered trademarks of MediGene AG. RhuDex(TM) is a registeredtrademark of MediGene Ltd. These trademarks may be owned or licensedin select locations only. - ends -MediGene AG is a publicly listed (Frankfurt: MDG, Prime Standard,TecDax) biotechnology company located in Martinsried/Munich, Germany,Oxford, UK, and San Diego, USA. MediGene is the first German biotechcompany to have drugs on the market, which are distributed by partnercompanies. MediGene has several drug candidates in clinicaldevelopment, two of which provide significant sales potential. Inaddition, the company pursues several development projects andpossesses innovative platform technologies for drug development.MediGene focuses on clinical research and development of novel drugsfor the treatment of cancer and autoimmune diseases.Contact MediGene AGE-mail: investor(at)medigene.comFax:++49 - 89 - 85 65 - 2920Julia Hofmann / Dr. Nadja Wolf, Public Relations, Tel.: ++49 - 89 -85 65 - 3324Dr. Georg Dönges, Investor Relations, Tel.: ++49 - 89 - 85 65 - 2946 --- End of Message ---MediGene AGLochhamer Strasse 11 Martinsried / München GermanyWKN: 502090; ISIN: DE0005020903 ; Listed: Prime Standard in Frankfurter Wertpapierbörse, 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: 11.12.2009 - 17:15 Uhr
Sprache: Deutsch
News-ID 9543
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