02.12.2003 – 07:33
euro adhoc: MediGene AG
MediGene Receives Approval for Anti-cancer
Drug LeuprogelÒ (Eligard®)
First drug approval for a German biotechnology company (E)
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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: email@example.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
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Tel.: +49 (0)89 8565 2986
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