PRESS RELEASE: Thomson Reuters ONE Ad-hoc/Medigene expands clinical trial plan for RhuDex® in PBC and updates development timelines

Medigene AG / Misc. matters / Ad hoc: MediGene expands clinical trial plan for RhuDex® in PBC and updates development timelines . Processed and transmitted by Thomson Reuters ONE. The issuer is solely responsible for the content of this announcement.

Martinsried/Munich, February 4, 2013. Medigene AG (Frankfurt, Prime Standard) announces that the Executive Board has decided, with the approval of the Supervisory Board, to expand the clinical development plan for RhuDex(®) in the treatment of autoimmune diseases. Following recommendations of the regulatory authorities and the Steering Committee, the planned phase IIa trial in the indication of primary biliary cirrhosis (PBC) is to be expanded from a three-arm to a four arm, controlled study and the planned treatment period for patients will be extended from three to six months. The aim is to increase the information value of the trial data collected in order to confirm the mode of action of RhuDex(®) in autoimmune diseases and facilitate the future approval of RhuDex(®) for PBC. This is expected to further increase the value of the drug candidate in both scientific and commercial terms.

Medigene will now develop the modified trial design. Subject to the successful completion of the necessary preparatory work and the approval of the study by the regulatory authorities, the start of this expanded phase II trial is scheduled for the first half of 2014 at the latest. It will replace the phase IIa trial with RhuDex(®) originally planned for 2013. As a result, the major financial expenses relating to a phase II trial will be deferred to 2014 and thereafter.

For more information please see today's press release at http://www.medigene.com/press

- End -

Contact Medigene AG Julia Hofmann, Claudia Burmester Investor & Public Relations Tel.: +49 - 89 - 20 00 33 - 33 01 Fax: +49 - 89 - 20 00 33 - 29 20 Email: investor@medigene.com

ad hoc release as pdf: http://hugin.info/132073/R/1675370/545758.pdf

This announcement is distributed by Thomson Reuters on behalf of Thomson Reuters clients. The owner of this announcement warrants that: (i) the releases contained herein are protected by copyright and other applicable laws; and (ii) they are solely responsible for the content, accuracy and originality of the information contained therein.

Source: Medigene AG via Thomson Reuters ONE [HUG#1675370]

--- End of Message ---

Medigene AG Lochhamer Strasse 11 Martinsried / München Germany

WKN: 502090;ISIN: DE0005020903; Listed: Freiverkehr in Börse Stuttgart, Freiverkehr in Hanseatische Wertpapierbörse zu Hamburg, 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;

http://www.medigene.com (END) Dow Jones Newswires

   February 04, 2013 14:54 ET (19:54 GMT)- - 02 54 PM EST 02-04-13