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02.12.2003 – 07:33

Medigene AG

euro adhoc: MediGene AG
MediGene Receives Approval for Anti-cancer Drug LeuprogelÒ (Eligard®) First drug approval for a German biotechnology company (E)

  Disclosure announcement transmitted by euro adhoc.
  The issuer is responsible for the content of this announcement.
Martinsried - San Diego, December 2, 2003: As the first German
biotechnology company, MediGene AG (Frankfurt, Prime Standard: MDG)
has received marketing authorization for a drug. The regulatory
authority responsible, the BfArM (Bundesinstitut für Arzneimittel und
Medizinprodukte = Federal Institute for pharmaceuticals and medical
devices) has granted marketing authorization for Germany for
LeuprogelÒ (One-month depot) to treat advanced prostate cancer.
Leuprogel® is marketed under the tradename, Eligard® in the U.S.. 
LeuprogelÒ (active substance: leuprolide acetate) combines standard
hormone therapy with a novel, patient-friendly and efficient drug
delivery system, the AtrigelÒ depot technology.
MediGene intends to commercialize LeuprogelÒ in cooperation with a
partner from the pharmaceuticals industry who is not yet appointed,
and plans market launch of LeuprogelÒ for the first half of 2004. The
marketing authorization application for the LeuprogelÒ three-months
depot is still undergoing approval procedure by the German
authorities. MediGene plans to submit marketing authorization
applications in other European countries as well. Marketing
authorization applications for the one- and three-months products
have already been submitted in Switzerland.
MediGene has acquired the license for LeuprogelÒ from the US company
Atrix Laboratories in April 2001, the developer of Atrigel®, and
holds the exclusive European marketing rights for the one-month,
three-months, four-months and six-months depot products. The market
volume for so-called LH-RH agonists such as LeuprogelÒ in the five
European key markets (Germany, Great Britain, France, Italy, Spain)
amounts to approximately 500 million EUR annually. Jointly with the
marketing partner, MediGene expects to reach a noticeable share in
this market.
- ends -
Contact:
MediGene AG, e-mail: investor@medigene.com, Fax:++ 49 - 89 - 85 65 -
2920
Julia Hofmann, Public Relations, Phone:++ 49 - 89 - 85 65 - 3324
Dr. Michael Nettersheim, Investor Relations, Phone:++ 49 - 89 - 85 65
- 2946
end of announcement        euro adhoc 02.12.2003

Further inquiry note:

Jessica Kern
Tel.: +49 (0)89 8565 2986
E-mail: j.kern@medigene.com

Branche: Biotechnology
ISIN: DE0005020903
WKN: 502090
Index: CDAX, HDAX, Midcap Market Index, Nemax 50, 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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