26.01.2004 – 08:03
euro adhoc: MediGene AG
MediGene Receives Approval for the
Three-Months Sustained Release Product Eligard® (previously known as
Disclosure announcement transmitted by euro adhoc. The issuer is responsible for the content of this announcement.
Martinsried - San Diego, January 26, 2004: The German-American biotechnology company MediGene AG (Frankfurt, Prime Standard: MDG) has received marketing authorization for Germany from the Bundesinstitut für Arzneimittel und Medizinprodukte (= Federal Institute for pharmaceuticals and medical devices), BfArM, for the three-months sustained release product of the anti-cancer drug Eligard® (previously known as Leuprogel®) for the treatment of advanced prostate cancer. The corresponding one-month sustained release product of this drug had received marketing authorization at the beginning of December 2003. The three-months sustained release product offers additional applications of Eligard®, thus enhancing its competitiveness. As announced on January 14, MediGene's partner Yamanouchi will take on market launch and sale of Eligard®. As part of the agreement with Yamanouchi, MediGene will receive a milestone payment for this approval of the three-months sustained release product.
MediGene and Yamanouchi are planning to submit marketing authorization applications in other European countries as well. Within the framework of the so-called "Mutual Recognition Procedure", the German approval will serve as a reference there. MediGene had acquired the license for commercialization of Eligard® in Europe from the US company Atrix Laboratories, Inc. in April 2001.
Contact: MediGene AG, Email: firstname.lastname@example.org, Fax: ++49-89-8565-2920 Julia Hofmann, Public Relations, ph.: ++49-89-8565-3324 Dr. Michael Nettersheim, Investor Relations, ph.:++49-89-8565-2946
end of announcement euro adhoc 26.01.2004
Further inquiry note:
Tel.: +49 (0)89 8565 2986
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Original content of: Medigene AG, transmitted by news aktuell