MediGene Decides on Extension of Clinical Development of Polyphenon(R) E Ointment to Additional Tumor Disease: Phase 2 Trial for Actinic Keratosis In Preparation -- Initiation of clinical phase 2 trial for actinic keratosis (precursor of skin cancer) planned for the second quarter of 2004. MARTINSRIED, Germany and SAN DIEGO, April 6 /PRNewswire-FirstCall/ -- The German-American biotechnology company MediGene AG (Frankfurt, Prime Standard: MDG) extends the clinical development ofits Polyphenon(R) E Ointment to another tumor disease and is preparing the initiation of a clinical phase 2 trial for the treatment of actinic keratosis, a precursor of skin cancer. In this trial which is planned to start in the second quarter of 2004,efficacy and safety of the Polyphenon(R) E Ointment applied against actinic keratosis will be investigated. The excellent data MediGene recently obtained in the phase 3 trial of Polyphenon(R) E Ointment for the treatment of genital warts (see our press release dated March 31, 2004) have been the basis for this decision. The results of the new phase 2 trial are expected in 2005. The extension of clinical development to actinic keratosis will increase the sales potential of Polyphenon(R) E Ointment by approximately euro 200 million to more than 300 euro million annually. Dr. Peter Heinrich, Chief Executive Officer of MediGene AG, comments: "The extension of the clinical development of our Polyphenon(R) E Ointment to the indication actinic keratosis will be a further move in our strategy of expanding MediGene's tumor drug pipeline, while focusing on the development of products close to the market at the same time. We act on the assumption that our Polyphenon(R) E Ointment has an immense potential for a number of dermatological tumor diseases, such as actinic keratosis and basal cell carcinoma, and we are just about to exploit this potential." Actinic keratosis & Polyphenon(R) E Ointment: Actinic keratoses are hornification disorders caused by excessive exposure of the skin to the sun, which may develop into malignant spinocellular carcinoma. Scientific research indicates that infection with human papilloma viruses (HPV) may also be involved in the onset and development of skin tumors such as actinic keratosis. Numerous findings indicate that the catechines in our Polyphenon(R) E Ointment inhibit basic functions of HPV, counteract specific changes in tumor cells and, moreover, stimulate the immune system. The active substance in Polyphenon(R) E Ointment is a defined extract from green tea leaves. Details on the trial: The clinical phase 2 trial on 60 patients showing the symptoms of multiple actinic keratosis will be carried out in a total of 6 leading clinical-dermatological centers in Germany and in Switzerland. The patients will treat their actinic keratosis in a predefined area of their skin, either on their heads or their faces, by applying Polyphenon(R) E Ointment daily. Important objectives of the trial are the verification of efficacy of the Polyphenon(R) E Ointment applied against actinic keratosis, as well as insights into safety and tolerability. The trial is placebo-controlled, i.e. a control group of patients will receive a placebo. The trial will be randomized (random assignment of treatment) and double-blinded (no disclosure to physician or patient during the trial). This press release contains forward-looking statements that involve risks and uncertainties. The forward-looking statements contained herein represent the judgement 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) is a trademark of MediGene AG, Polyphenon(R) E is a trademark of Mitsui Norin, Eligard(R) is a trademark of Atrix. About MediGene: MediGene AG is a publicly quoted (Frankfurt: Prime Standard), German-American biotechnology company located in Martinsried, Germany and San Diego, USA. MediGene has the most mature drug development pipeline in the German biotech industry and possesses innovative platform technologies. With Eligard(R) for the treatment of prostate cancer, MediGene is the first German biotech company with an approved drug on the verge of market launch. MediGene's core competence lies in research and development of novel approaches for the treatment of various tumor diseases. Thus MediGene focuses on indications of high medical need and economic opportunities. DATASOURCE: MediGene AG CONTACT: Julia Hofmann, Public Relations, +49-89-85-65-3324, Dr. Michael Nettersheim, Investor Relations, +49-89-85-65-2946, Fax: +49-89-85-65-2920, both of MediGene AG, ; Jonathan Fassberg, The Trout Group, +1-212-477-9007, ext. 31, for MediGene AG

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