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| ![]() | ![]() MediGene's Drug Eligard Launched in Spain and Further European CountriesPress Release November 15, 2005 Marketing Partner Astellas Pharma started market launch of the prostate cancer drug in additional European countries, including Spain * MediGene receives milestone payment from Astellas Pharma for achie ving market launch in Spain, in addition to royalties on sales of Eligard® MARTINSRIED, Germany, SAN DIEGO, November 15, 2005. The German-American biotech company MediGene AG (Frankfurt, Prime Standard: MDG) anounces the launch of its prostate cancer drug Eligard®, in Spain. With a potential for sales in this indication of € 100 million, Spain is one of the largest markets in Europe for drugs of this category. Currently Eligard® is available for patients and physicians in the following countries: Germany, Spain, Portugal, the Netherlands and Switzerland. Over the next few months, this prescription drug for the treatment of advanced prostate cancer will be launched in a total of 25 countries. MediGene's partner, Astellas Pharma, has started pan-European commercialization of the drug, which is already very successful in Germany. Upon market launch in Spain, MediGene receives a milestone payment from Astellas. In addition, MediGene will receive royalties on the sales of Eligard® in all European countries. "These additional launches of Eligard are an important prerequisite for the achievement our 2005 financial goal. We are very satisfied with Astellas Pharma as our marketing partner. The comprehensive and experienced distribution network will ensure that Eligard® is marketed as successfully throughout Europe as it has been the case in Germany.", says Dr. Peter Heinrich, CEO of MediGene AG. Astellas Pharma is the third largest pharmaceuticals company in Europe in the field of urology, and the market leader in the benign prostate hyperplasia segment. Mr Yasuo Ishii, Chairman and CEO of Astellas Pharma Europe Ltd, comments: "Eligard® is already a great success on the German market. Now we want to spread this success over the whole of Europe." MediGene acquired the license for pan-European commercialization of Eligard® from the US Company Atrix Laboratories, Inc. (today's QLT Inc., Canada) in April 2001, and successfully took the drug through the approval procedure for Germany and Switzerland. In May 2004, Eligard® was launched in Germany by MediGene's partner Yamanouchi Pharmaceutical Co. Ltd., now called Astellas Pharma. In December 2004, the mutual recognition procedure (MRP) for the one-month and three-months products was successfully completed in 23 out of 25 additional European countries. After completion of pricing and reimbursement negotiations, which are necessary in most countries prior to commercialization, the launch of the drug on the individual markets has started. About Eligard®: Eligard® is an LH-RH agonist (LH-RH = luteinizing hormone-releasing hormone) which significantly and consistently reduces the testosterone level in the body, thus suppressing tumor growth in patients suffering from advanced, hormone-dependent prostate cancer. Eligard® (active substance: leuprolide acetate) combines standard hormone therapy with a novel, patient-friendly and efficient drug delivery system, the Atrigel® depot technology. Liquid Eligard® is injected subcutaneously into the patient where it forms a solid implant, slowly and steadily releasing the drug, while the biodegradable depot disintegrates. The clinical trials have shown that Eligard® is safe, well tolerated and efficient. This press release contains forward-looking statements that involve risks and uncertainties. The forward-looking statements contained herein represent the judgment of MediGene as of the date of this release. These forward-looking statements are no guarantees for future performance, and the forward-looking events discussed in this press release may not occur. MediGene disclaims any intent or obligation to update any of these forward-looking statements. MediGeneTM is a trademark of MediGene AG, Eligard® is a trademark of QLT USA, Inc. - ends - MediGene AG is a publicly quoted (Frankfurt: Prime Standard), German-American biotechnology company located in Martinsried, Germany and San Diego, USA. MediGene is the first German biotech company with a drug on the market. The company has the most mature drug development pipeline in the German biotech industry and possesses innovative platform technologies. MediGene's core competence lies in research and development of novel approaches for the treatment of various tumor diseases. Thus MediGene focuses on indications of high medical need and economic opportunities. Contact MediGene AG: Email: investor@medigene.com Fax: ++49 - 89 - 85 65- 2920 Dr. Georg Dönges, Public Relations, Tel.: ++49 - 89 - 85 65 - 3317 Dr. Michael Nettersheim, Investor Relations, Tel.: ++49 - 89 - 85 65 - 2946 Contact Astellas Pharma Europe Ltd: media@eu.astellas.com
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