FDA Grants Orphan Drug Designation for MediGene's Drug Candidate EndoTAG(TM)-1

Mittwoch, 20. Mai 2009 08:31
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Orphan drug designation ensures market exclusivity for a period of
seven years following market approval

Martinsried/Munich, May 20, 2009. MediGene AG (Frankfurt: MDG, Prime
Standard, TecDAX) has obtained orphan drug designation from the US
regulatory authority FDA (US Food and Drug Administration) for
paclitaxel, the active ingredient in MediGene's drug candidate
EndoTAG(TM)-1 for the indication pancreatic cancer. Orphan drug
designation for EndoTAG(TM)-1 in this indication was already granted
in the European Union in 2006.

Orphan drug designation in the USA permits granting of a seven-year
market exclusivity following market approval. Further benefits are
waiving of application fees for New drug Application, and the
opportunity for a scientific exchange with the FDA about further
developments in the orphan indication. In addition, a tax reduction
for the clinical development expenses of the drug candidate incurred
in the USA may be utilized. The orphan drug program is meant to
encourage the development of therapies for rare and severe diseases.

Dr. Frank Mathias, Chief Executive Officer of MediGene AG, comments:
"The orphan drug designation in the USA once more emphasizes the
significance of EndoTAG(TM)-1 for the treatment of pancreatic
carcinoma, which is very difficult to treat. It facilitates the
future scientific exchange between MediGene and the regulatory
authority. In addition, it provides financial incentives for the
further development of EndoTAG(TM)-1 for the treatment of pancreatic
carcinoma. The market exclusivity granted upon market approval
enhances patent protection by adding independent protection against
copying, thus improving our product's competitive position."

About EndoTAG(TM)-1: The drug candidate EndoTAG(TM)-1 selectively
attacks blood vessels needed for the growth of tumors. It is a novel
combination of positively charged liposomes - minute globules of
lipid molecules - and the embedded active substance paclitaxel.
EndoTAG(TM)-1 is targeted to the negatively charged cells that are
specifically lining newly formed tumor blood vessels. Thus only tumor
blood vessels are attacked, without harm to those in healthy tissue.
At the same time EndoTAG(TM)-1 inhibits the development of new blood
vessels, thereby suppressing further tumor growth.

In October 2008 MediGene reported positive results obtained in a
clinical phase II trial of the drug candidate EndoTAG(TM)-1 for the
treatment of pancreatic carcinoma. Since 2007, a further phase II
trial of EndoTAG(TM)-1 for the treatment of triple receptor-negative
breast cancer has been in progress. The results of this trial are
expected for the first half of 2010.

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.
MediGene(TM) and EndoTAG(TM) are trademarks of MediGene AG. This
trademark may be held or licensed for specific countries.

- ends -

MediGene AG is a publicly listed (Frankfurt: MDG, Prime Standard,
TecDAX) biotechnology company located in Martinsried/Munich, Germany,
with subsidiaries in Oxford, UK and San Diego, USA. MediGene is the
first German biotech company to have drugs on the market, which are
being distributed by partner companies and has several drug
candidates in clinical development, two of which provide significant
sales potential. In addition, the company has numerous projects in
research and pre-clinical development and possesses innovative
platform technologies. MediGene focuses on the research and
development of novel drugs for the treatment of cancer and autoimmune
diseases

Contact MediGene AG
E-mail: investor@medigene.com
Fax: +49 - 89 - 85 65 - 2920
Julia Hofmann / Dr. Nadja Wolf, Public Relations, Tel.: +49 - 89 - 85
65 - 3324
Dr. Georg Dönges, Investor Relations, Tel.: +49 - 89 - 85 65 - 2946



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MediGene AG
Lochhamer Strasse 11 Martinsried / München Germany

WKN:
502090; ISIN: DE0005020903 ;
Listed: Prime Standard in Frankfurter Wertpapierbörse, Freiverkehr in
Bayerische Börse München,
Freiverkehr in Börse Düsseldorf, Freiverkehr in Börse Stuttgart,
Freiverkehr in Hanseatische Wertpapierbörse zu Hamburg, Freiverkehr
in Niedersächsische Börse zu Hannover,
Regulierter Markt in Frankfurter Wertpapierbörse;
Kapcsolódó linkek: Medigene AG
Szerző:
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