MARTINSRIED, Germany and SAN DIEGO, Feb. 17 /PRNewswire-FirstCall/ -- The German-American biotech company MediGene AG (Frankfurt, TecDAX) announces that its drug* for the treatment of advanced prostate cancer was launched in France yesterday. The drug* is now available in 11 European countries. Apart from France, the Scandinavian countries Denmark, Sweden, Norway, and Finland, as well as Austria have supervened since November of last year. MediGene’s marketing partner Astellas Pharma launched the drug in these countries and will now make a milestone payment to MediGene after the launch in France. In addition, MediGene receives royalties on the sales of the drug* in all of these countries. Market launch in Europe is scheduled to be completed in the next few months, and the drug* which is only available on prescription will is expected to be available in a total of 24 European countries.
“The launch of our first drug* by our marketing partner Astellas Pharma proceeds as scheduled. Sales in Germany increase continuously, and in the other countries we notice a very positive development. Therefore we expect a successful introduction in France as well. As a result of the increasing sales, and of the milestone payments we received within our marketing partnership for the Polyphenon(R) E Ointment we expect a very good result for the current quarter”, comments Dr. Peter Heinrich, Chief Executive Officer of MediGene AG.
Astellas Pharma is among the leading European pharmaceuticals companies in the field of urology, and the market leader in the benign prostate hyperplasia segment.
MediGene acquired the license for pan-European commercialization of the drug from the US Company Atrix Laboratories (today’s QLT USA, Inc.) in April 2001, and first of all successfully took the drug through the approval procedure for Germany and Switzerland. In May 2004, the drug was launched in Germany by MediGene’s partner Yamanouchi Pharmaceutical Co. Ltd., today’s Astellas Pharma. In December 2004, the mutual recognition procedure (MRP) for the one-month and three-months products was successfully completed in 23 additional European countries. In the second half of last year, Astellas Pharma started the launch of the drug on the individual markets.
About the drug*:
The drug* 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. The drug* (active substance: leuprolide acetate) combines standard hormone therapy with a novel, patient- friendly and efficient drug delivery system, the Atrigel(R) depot technology. The liquid drug* 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 the drug* 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 judgement 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, Polyphenon(R) E is a trademark of Mitsui Norin.
* For legal reasons, product name and indication are not mentioned in the internet (German Law on Drug Advertising) ** Temporary name while under development
MediGene AG is a publicly quoted , 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 NDA for a second drug, Polyphenon(R) E Ointment, has been submitted. In addition, MediGene has several oncological drug candidates undergoing clinical development, and possesses innovative platform technologies for drug development. MediGene’s core competence lies in research into and development of novel approaches for the treatment of various cancer and tumor diseases.
MediGene AG
CONTACT: Dr. Georg Donges, Public Relations, +49-89-8565-3317, or Dr.Michael Nettersheim, Investor Relations, +49-89-8565-2946, both of MediGeneAG, Fax: +49-89-8565-2920, investor@medigene.com
