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31.03.2004 – 08:05

Medigene AG

euro adhoc: MediGene AG
MediGene Achieves Excellent Clinical Results With Polyphenon® E Ointment in European Phase 3 Trial (E)

  Disclosure announcement transmitted by euro adhoc.
  The issuer is responsible for the content of this announcement.
Martinsried - San Diego, March 31, 2004. The German-American biotech
company MediGene AG (Frankfurt, Prime Standard: MDG) has achieved
excellent results in a European phase 3 trial of the Polyphenon® 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 will be prerequisites for the
marketing authorization application for Polyphenon® 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® 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® 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® 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.
end of announcement        euro adhoc 31.03.2004

Further inquiry note:

Julia Hofmann
Tel.: +49 (0)89 8565 3324

Branche: Biotechnology
ISIN: DE0005020903
WKN: 502090
Index: CDAX, Prime All Share, Prime Standard, Technologie All Share
Börsen: Frankfurter Wertpapierbörse / regulated dealing
Niedersächsische Börse zu Hannover / free trade
Berliner Wertpapierbörse / free trade
Bayerische Börse / free trade
Hamburger Wertpapierbörse / free trade
Bremer Wertpapierbörse (BWB) / free trade
Börse Düsseldorf / free trade
Baden-Württembergische Wertpapierbörse / free trade

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