Martinsried / München, Germany, Apr 25, 2008 - (ABN Newswire) - Corporate news announcement processed and transmitted by Hugin ASA. The issuer is solely responsible for the content of this announcement. ---------------------------------------------------------------------- --------------



A new era for MediGene: first drug to be marketed by the company itself   Martinsried/Munich, 25. April 2008. MediGene AG (Frankfurt, Prime Standard: MDG) announced that the European Medicines Agency (EMEA) Committee for Medicinal Products for Human Use (CHMP) has concluded the approval procedures for Oracea® for the treatment of rosacea by issuing a positive opinion. The formal marketing authorization by the European Commission is therefore expected within the next few weeks. Oracea® shall be the first drug marketed by MediGene itself. The company's currently marketed drugs (Eligard® in Europe, and Veregen(TM)/Polyphenon® E Ointment in the USA) are marketed by partner companies.   Dr. Peter Heinrich, Chief Executive Officer of MediGene AG, commented: "A marketing authorization for Oracea® would mark the beginning of a new era for MediGene, and we are now preparing our first market launch of a drug. Drug commercialization in selected European countries by our selves will enable us to profit by our products much more, and we are also planning to enlarge MediGene's sales portfolio step by step - both by proprietary development such as Veregen(TM) (for which we expect to obtain the first marketing authorization in Europe at the end of 2008), and by licensing other products".   The recommendation for approval of Oracea® initially applies to Germany, UK, Italy, Austria, Ireland, Sweden, Finland, Luxembourg, and the Netherlands. Within the scope of the mutual recognition procedure, MediGene is also planning to submit marketing authorization applications in additional European countries. MediGene plans to market Oracea® in some selected countries, and for the remaining countries the company intends to conclude marketing partnerships. MediGene acquired the pan-European marketing rights to the drug from the US company CollaGenex, Inc. in 2006. Oracea® has been successful on the US market since 2006.   About Oracea®: Oracea® is the first drug for systemic long-term treatment of rosacea with inflammatory lesions. In clinical trials Oracea® was characterized by high efficacy and safety. By its innovative and low-dosed administration, the active substance doxycycline (tetracycline) is released in such a way that it has an anti-inflammatory effect without affecting the body's normal bacteria. Therefore treatment with Oracea® led to significantly fewer adverse effects than established tetracycline therapies. Moreover there has been no development of any bacterial resistance during the clinical trials. Oracea® therefore offers physicians and patients a new therapeutic option in the treatment of rosacea.   About Rosacea: Rosacea is an inflammatory disease of the facial skin, especially in the center part of the face. The onset of the disease is usually between the age of 30 - 40, and it is a chronic, episodic disease. The cause of rosacea is still unknown, and both genetic predisposition and outside influences appear to be involved in the onset of the disease. About 15 million people in Europe are affected by rosacea.   This press release contains forward-looking statements that involve risks and uncertainties. The forward-looking statements contained herein represent the judgment of MediGene as of the date of this release. These forward-looking statements are no guarantees for future performance, and the forward-looking events discussed in this press release may not occur. MediGene disclaims any intent or obligation to update any of these forward-looking statements. MediGene(TM) and Veregen(TM) are trademarks of MediGene AG, Polyphenon® is a registered trademark of Mitsui Norin Co., Ltd., Oracea® is a registered trademark of CollaGenex Pharmaceuticals Inc., Eligard® is a registered trademark of QLT USA, Inc. These trademarks may be owned or licensed in select locations only.     - ends -   MediGene AG is a publicly quoted (Frankfurt, Prime Standard: MDG) biotechnology company located in Martinsried/Munich, Germany, with subsidiaries in Oxford, UK and San Diego, USA. MediGene is the first German biotech company to have drugs on the market, which are distributed by partner companies. The company plans to start its own sales activities in select European countries. MediGene's drug pipeline includes several products in clinical development, among them two blockbuster-candidates with an estimated revenue potential of more than one billion Euro. In addition, MediGene is active in various research projects and possesses platform technologies for developing active compounds. MediGene concentrates on researching, developing and commercializing novel drugs in three therapeutic areas: cancer, autoimmune diseases, and skin diseases.     Contact MediGene AG: Email: investor@medigene.com Fax:   ++49 - 89 - 85 65 - 2920 Julia Hofmann / Dr. Georg Dönges, Public Relations                      Tel.:   ++49 - 89 - 85 65 - 3317 Dr. Michael Nettersheim/ Dr. Georg Dönges, Investor Relations    Tel.:   ++49 - 89 - 85 65 - 2946    

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MediGene AG Lochhamer Strasse 11 Martinsried / München Germany

WKN: 502090; ISIN: DE0005020903 ; Index: Prime All Share, CDAX, TECH All Share, HDAX, MIDCAP, TecDAX; 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, Geregelter Markt in Frankfurter Wertpapierbörse;

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MediGene AG

http://www.medigene.com

ISIN: DE0005020903

Stock Identifier: XFRA.MDG