MediGene: European Approval Procedure for the Six-Months Dosage of
Cancer Drug Eligard® Successfully Completed
Martinsried/Munich, August 31, 2007. MediGene AG (Frankfurt, Prime
Standard: MDG) announces that the European approval procedure for the
six-month dosage of Eligard® was successfully completed. As soon as
this positive decision has been implemented in the individual
countries, this dosage of the drug for the treatment of prostate
cancer can be launched in Europe. In Germany, the six-month dosage
has been successful since March 2007. After subcutaneous injection of
this dosage, the drug is released steadily over a period of six
months. Eligard® is the only six-month depot product of a drug
against prostate cancer available in Europe. The one-month and
three-month products have been available in all major European
countries. The drug is marketed by MediGene's licensee Astellas
Pharma Europe Ltd. MediGene expects that the Eligard® revenue will
meet the target projected for 2007.
Dr. Peter Heinrich, Chief Executive Officer of MediGene AG, comments:
"The six-month dosage of Eligard® represents a further improvement in
patient management. There has been tremendous response since the
launch of the Eligard 6 month formulation earlier this year in
Germany. We are now glad that we can offer this 6 month dosage to
patients across Europe."
MediGene acquired the licence for pan-European commercialization of
Eligard® from the US Company Atrix Laboratories, Inc. (today's QLT
Inc., USA) in April 2001, and successfully took the drug through the
approval procedure, first of all in Germany, and afterwards, in
cooperation with Astellas in Europe. Eligard® has been marketed in
Europe by MediGene's licensee Astellas Pharma Europe Ltd since May
2004. The six-month dosage (45 mgs) was launched in Germany in March
2007. Other available formulations of Eligard include the one-month
(7.5 mgs), and three-month (22.5 mgs) depot products.
Eligard® is the first product of MediGene's broad drug pipeline that
has been available on the European market. Another drug, the
Polyphenon® E Ointment, was approved for marketing by the US
regulatory authority FDA, and the third drug, Oracea®, is currently
undergoing approval procedures in Europe. In addition, MediGene has
drug candidates for the treatment of cancer and autoimmune diseases
in clinical development, and possesses several innovative platform
technologies, i.e. EndoTAG®, HSV, and mTCRs (soluble T-cell
receptors).
About Eligard®: Eligard® is a LH-RH agonist (LH-RH = luteinizing
hormone-releasing hormone) which significantly and consistently
reduces the testosterone level in the body, thus suppressing tumour
growth in patients suffering from advanced, hormone-dependent
prostate cancer.
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 and EndoTAGTM-1are trademarks of MediGene AG, RhuDex® is a
trademark of MediGene Ltd., Polyphenon® is a trademark of
Mitsui-Norin, Eligard® is a trademark of QLT, Inc.
- ends -
MediGene AG is a publicly quoted (Frankfurt: Prime Standard: MDG)
biotechnology company located in Martinsried/Munich, Germany, with
subsidiaries in Oxford, UK and San Diego, USA. MediGene is the first
German biotech company with a drug on the market. Another drug
obtained marketing authorization for the USA, two drug candidates are
currently undergoing the European approval procedures. Furthermore
MediGene has several drug candidates for the treatment of various
types of cancer and autoimmune diseases in clinical development, and
possesses innovative platform technologies for drug development.
Contact MediGene AG:
Email: investor@medigene.com Fax:
++49 - 89 - 85 65 - 2920
Julia Hofmann/Dr. Georg Dönges, Public
Relations Tel.: ++49 - 89 - 85 65 -
3317
Dr. Michael Nettersheim, Investor
Relations
Tel.: ++49 - 89 - 85 65 - 2946
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MediGene AG
Lochhamer Strasse 11 Martinsried / München Germany
WKN:
502090; ISIN: DE0005020903 ; Index: Prime All Share, CDAX, TECH All
Share, HDAX, MIDCAP, TecDAX;
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