MediGene receives Positive Assessment on Market Authorisation for Veregen® in First European Countries

Friday, 10. July 2009 13:00
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Martinsried/Munich, July 10, 2009. MediGene AG (Frankfurt: MDG, Prime
Standard, TecDAX) today announces that its Marketing Authorisation
Application for the medicinal product Veregen® (formerly Polyphenon
E® Ointment) for the treatment of genital warts has been assessed
positively by the national regulatory authorities of Germany,
Austria, and Spain. This binding decision guarantees that national
Marketing Authorisations in these countries will be formally granted
by the authorities within the next few months. The Marketing
Authorisation of Veregen® in Germany, the Reference Member State in
this Decentralized Procedure, shall provide the basis for additional
Marketing Authorisations in other European countries via the Mutual
Recognition Procedure.

MediGene is planning commercialization of Veregen® in Germany and
other European countries via distribution partners. In the USA,
Veregen® is already marketed by MediGene's licensee Nycomed US, Inc.
MediGene has recently announced the conclusion of an agreement with
the Spanish company Juste S.A.Q.F. for the distribution of Veregen®
in Spain and Portugal.

Dr. Axel Mescheder, Chief Scientific Officer & Chief Development
Officer of MediGene AG commented: "We are very pleased with this
decision by the regulatory authorities. Veregen® is the first
proprietary development compound of MediGene AG, and therefore this
positive assessment of the first Marketing Authorisation Applications
in Europe is an important milestone for our company. Following
approval and launch of Veregen® in the USA, we are keen to make the
product accessible to patients in Europe as soon as possible."

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 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 extract from
green tea leaves 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 via MediGene's licensee Nycomed US
(PharmaDerm) under this name. In Europe, Marketing Authorisation
Applications under the Decentralised Procedure have been submitted in
Germany, Austria, and Spain and has been 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.

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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
diseases.

Contact MediGene AG
E-mail: investor@medigene.com
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

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