MediGene Achieves Excellent Clinical Results With Polyphenon(R) E Ointment in European Phase 3 Trial * Data indicate high and lasting efficacy as well as excellent safety in treatment of genital warts. MARTINSRIED, Germany and SAN DIEGO, March 31 /PRNewswire-FirstCall/ -- The German-American biotech company MediGene AG (Frankfurt, Prime Standard: MDG) has achieved excellent results in a European phase 3 trial of the Polyphenon(R) E Ointment for the treatment of genital warts. The statistically significant trial with more than 500 patients showed a high and lasting efficacy of the drug with extremely low systemic adverse reactions. The results of this trial, along with the data from the still ongoing American phase 3 trial willbe prerequisites for the marketing authorization application for Polyphenon(R) E Ointment. The pooled results of both trials are expected at the end of 2004. In these two phase 3 trials, efficacy and safety of Polyphenon(R) E Ointment for the treatment of external genital warts are being investigated in three groups of patients each (10 % and 15 % ointment compared to placebo). The European trial has achieved all objectives of the trial. Approximately 53 % of the patient treated with the 15 % Polyphenon(R) E Ointment showed complete clearance of all external genital warts (clear statistical significance p = 0.01 compared to placebo). In about 78 % of all patients treated with Polyphenon(R) E Ointment, most or all of the genital warts disappeared. Recurrence of genital warts during the twelve weeks of follow-up occurred only in a very small number of patients (less than 5 %). Local skin reactions (e.g. itching, burning) were mostly mild or moderate. The trial is based on discussions with European regulatory authorities, had been agreed with the US FDA and complies with international quality standards. Dr. Peter Heinrich, Chief Executive Officer of MediGene AG, comments: "I am very happy about the convincing and competitive phase 3 results. Thedistinctly positive data from the European trial represent an important milestone on our way to marketing authorization. The results indicate that this drug candidate which is close to the market has a tremendous potential." Polyphenon(R) E Ointment: The active substance in Polyphenon(R) E Ointment is a defined extract from green tea leaves. MediGene estimates the sales potential of this drug for the treatment of genital warts to be more than 100 million Euro annually. Pre-clinical findings indicate that Polyphenon(R) E Ointment may also be suited for the treatment of other skin diseases. Genital warts: Genital warts are disfiguring and contagious but benign skin tumors in the genital and anal area which are mostly difficult to treat. Genital warts are one of the most common and fastest spreading venereal diseases worldwide. Approximately 14 million people in North America and 15 million people in Europe are infected by human papilloma viruses (HPV 6 or 11), that cause genital warts. Additional details on the trial: The phase 3 trial was carried out in a total of 48 hospitals in 7 European countries and South Africa. The study was randomized (random assignment of treatment) and double-blind (no disclosure to physician or patient during the trial). The ointment was applied to the affected areas three times a day over a maximum period of 16 weeks. The primary objective of the trial was achieved: approximately 53 % of the patients treated with the 15 % Polyphenon(R) E Ointment completely recovered from all existing as well as newly appearing warts (10 % Polyphenon(R) E Ointment: 51 %, placebo: 37 %). The other primary objective was to prove the safety of the drug. The majority of local skin reactions were mild to moderate, and only in afew cases severe local reactions occurred. The secondary objectives of the trial were also achieved: complete recovery from warts that already existed at the beginning of the treatment (baseline warts) of 55 % of the patients with 15 % ointment, of 53 % of the patients with 10 % ointment and of 36 % of the patients treated with placebo (clear statistical significance compared to placebo: p = 0.01 for 15 % ointment, p = 0.03 for 10 % ointment). 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) isa 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, or Dr. Michael Nettersheim, Investor Relations, +49-89-85-65-2946, both of MediGene AG, , Fax, +49-89-85-65-2920

Copyright