RhuDex(TM) Clinical Development to Continue Following Feedback from
Regulatory Authorities
(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, October 5, 2009. MediGene AG (Frankfurt: MDG,Prime Standard, TecDAX) received feedback from the UK MHRA (Medicinesand Healthcare products Regulatory Agency) regarding the in-vitrostudies conducted with the drug candidate RhuDex(TM) for thetreatment of rheumatoid arthritis. These in-vitro studies examinedpotential effects of RhuDex(TM) on the vascular system or anyarteriosclerotic blood vessels. Since these tests did not suggest anynegative effects of RhuDex(TM), the MHRA agreed to a continuation ofthe drug candidate's clinical development, without requesting anyfurther in vitro or ex vivo data.MediGene is planning to resume the Phase I clinical development forRhuDex(TM), thus laying the necessary foundation for a clinical PhaseII trial in patients. As the extended plan for clinical developmentis drafted, MediGene will coordinate with the competent regulatoryauthorities.Following a successful Phase IIa trial in 29 patients during thefirst six months of 2008, MediGene conducted a clinical Phase I trialof a new tablet formulation of RhuDex(TM). This trial was put on holdin July 2008, following the death of a trial participant frommyocardial infarction. The autopsy, revealed severe impairment ofcardiac function of the volunteer deemed to be present prior toadmission to the trial, as well as other scientific findings.MediGene considered any causal correlation between the death of thepatient and the administration of RhuDex(TM) to be unlikely, but forsafety reasons the Company proceeded to test RhuDex(TM) in a seriesof further laboratory studies in coordination with the MHRA.Dr. Axel Mescheder, CSO & CDO of MediGene AG: "We are very happy thatwe are in a position to continue clinical development of thisinnovative drug candidate for the treatment of immune-mediateddiseases. We are pleased that the decision by MHRA is in line withMediGene's assessment. "RhuDex(TM): RhuDex(TM) is being developed as a disease-modifying drugfor the treatment of rheumathoid arthritis, aiming at the successfulgroup of "Disease-Modifiying Antirheumatic Drugs" (DMARDs). As thefirst orally administered and at the same time specifically effectiveDMARD, RhuDex(TM) may provide a distinct competitive advantage. Themode of action of RhuDex(TM) is targeted at stopping T-cellactivation by specifically blocking the very well-defined targetprotein CD80, thus inhibiting the release of cytokines whichstimulate inflammation. Thus the disease-causing mechanism inhibitedin a very specific way.Rheumatoid arthritis: rheumatoid arthritis is the most commoninflammatory arthropathy worldwide. More than 1% of the worldpopulation is affected by this chronic, systemic disease of theconnective tissue which leads to pain, deformity, restrictedmobility, and often to stiffening of the joints affected.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® is a registered trademark ofMediGene AG. RhuDex(TM) is a registered trademark of MediGene Ltd.These trademarks may be owned or licensed in 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, Regulierter Markt in Frankfurter Wertpapierbörse, Freiverkehr in Börse Stuttgart, Freiverkehr in Bayerische Börse München, Freiverkehr in Hanseatische Wertpapierbörse zu Hamburg, Freiverkehr in Niedersächsische Börse zu Hannover, Freiverkehr in Börse Düsseldorf;
Datum: 05.10.2009 - 10:30 Uhr
Sprache: Deutsch
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