MediGene AG Receives Marketing Authorization for Veregen® in Germany

Wednesday, 09. September 2009 08:31
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Martinsried/Munich, September 09, 2009. MediGene AG (Frankfurt: MDG,
Prime Standard, TecDAX) announces that it has received German
marketing authorization for Veregen® for the treatment of genital
warts from the Federal Institute for Drugs and Medical Devices
(Bundesinstitut für Arzneimittel und Medizinprodukte = BfArM).

As previously announced in July 2009, the marketing authorization
application for Veregen® (formerly Polyphenon E® Ointment) was
assessed positively in a decentralized approval procedure by the
German, Austrian, and Spanish national regulatory authorities. The
formal issue of marketing authorization in Germany is the first
implementation of the assessment by a national regulatory authority.
Marketing authorization of Veregen® in Germany, the reference member
state in this decentralized procedure, will now provide a basis for
additional marketing authorization applications to be submitted in
additional European countries. The issuance of formal marketing
authorizations in Austria and Spain are expected within the next few

MediGene intends to distribute Veregen® in Germany and other European
countries via marketing partners. In the USA Veregen® is already
available, and is distributed by MediGene's licensee Nycomed US Inc.
In addition, MediGene recently announced the conclusion of a
partnership with the Spanish company Juste S.A.Q.F. for the
distribution of Veregen® in Spain and Portugal.

Dr. Frank Mathias, Chief Executive Officer of MediGene AG, commented:
"Veregen® is MediGene's first proprietary development and German
marketing authorization opens up market entry into Europe. I am
confident that we will be able to conclude a marketing partnership
for Germany within the next few weeks, enabling us to provide
pharmacies and patients with the drug."

Veregen®: Veregen® for the treatment of genital warts contains a
defined extract from green tea leaves. MediGene acquired the basic
rights to the active substance in Veregen® from the Canadian company
Epitome Pharmaceuticals, Inc., in 1999, and was solely responsible
for the drug's successful preclinical and clinical development, as
well as for the approval process. Moreover the patent protection was
further upgraded by a number of proprietary inventions. The green tea
leaf extract is manufactured by the Japanese company Mitsui Norin
Co., Ltd. The drug's name during development was Polyphenon E®
Ointment. The US market approval was made out to Veregen®, and the
product is distributed in the USA under this name via MediGene's
licensee Nycomed US (PharmaDerm). In Europe, marketing authorization
applications under the decentralized procedure have been submitted in
Germany, Austria, and Spain, and were assessed positively by the
national authorities.

This press release contains forward-looking statements representing
the opinion of MediGene as of the date of this release. The actual
results achieved by MediGene may differ significantly from the
statements made herein. MediGene is not bound to update any of these
forward-looking statements. MediGene® and Veregen® are registered
trademarks of MediGene AG. Polyphenon E® is a registered trademark of
Mitsui Norin Co., Ltd. These trademarks may be owned or licensed in
select locations only.

- ends -

MediGene AG is a publicly listed (Frankfurt, Prime Standard: MDG,
TecDax) 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
being distributed by partner companies and has several drug
candidates in clinical development, two of which provide significant
sales potential. In addition, the company has numerous projects in
research and pre-clinical development and possesses innovative
platform technologies. MediGene focuses on the research and
development of novel drugs for the treatment of cancer and autoimmune

Contact MediGene AG
Fax: +49 - 89 - 85 65 - 2920
Julia Hofmann / Dr. Nadja Wolf, Public Relations, Tel.: +49 - 89 - 85
65 - 3324
Dr. Georg Dönges, Investor Relations, Tel.: +49 - 89 - 85 65 - 2946

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MediGene AG
Lochhamer Strasse 11 Martinsried / München Germany

502090; ISIN: DE0005020903 ;
Listed: Prime Standard in Frankfurter Wertpapierbörse, Freiverkehr in
Bayerische Börse München,
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Freiverkehr in Hanseatische Wertpapierbörse zu Hamburg, Freiverkehr
in Niedersächsische Börse zu Hannover,
Regulierter Markt in Frankfurter Wertpapierbörse;
Related Links: Medigene AG
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