MediGene Initiates Phase 2 Clinical Trial of Polyphenon(R) E Ointment for the Treatment of Actinic Keratosis on Schedule Expanding Market Potential for Polyphhenon(R) E MARTINSRIED, Germany and SAN DIEGO, April 29 /PRNewswire-FirstCall/ -- Today the German-American biotechnology company MediGene AG (Frankfurt, Prime Standard: MDG) initiated a phase 2 clinical trial of Polyphenon(R) E Ointment for the treatment of actinic keratosis, a precursor of skin cancer. With the enrolment of the first patient the company has achieved the extension of the clinical development of its Polyphenon(R) E Ointment to another skin tumor disease, as announced on April 6, 2004. In this trial, the efficacy, safety and tolerability of the Polyphenon(R) E Ointment on actinic keratosis will be investigated. The results of this trial are expected in 2005. Up to now, MediGene has been developing Polyphenon(R) E Ointment for the treatment of genital warts and has achieved excellent results in a phase 3 clinical trial in March 2004. 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 euro 300 million annually. Trial design: Six leading clinical-dermatological centers in Germany and in Switzerland will carry out the phase 2 clinical trial on 60 patients showing the symptoms of multiple actinic keratosis. The patients will treat their actinic keratosis in a defined area of their skin, either on their heads or 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 (both physician and patient are not informed whether the drug or a placebo is administered). 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 certain 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. 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: Public Relations, Julia Hofmann, +49-89-85-65-3324, or Investor Relations, Dr. Michael Nettersheim, +49-89-85-65-2946, or, , both for MediGene AG, Fax: +49-89-85-65-2920

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