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European Regulatory Authority (EMEA) Recommends Granting of Marketing Authorization for MediGene's Drug Oracea®

Corporate news announcement processed and transmitted by Hugin ASA.
The issuer is solely responsible for the content of this
announcement.
----------------------------------------------------------------------
--------------




A new era for MediGene: first drug to be marketed by the company
itself
 
Martinsried/Munich, 25. April 2008. MediGene AG (Frankfurt, Prime
Standard: MDG) announced that the European Medicines Agency (EMEA)
Committee for Medicinal Products for Human Use (CHMP) has concluded
the approval procedures for Oracea® for the treatment of rosacea by
issuing a positive opinion. The formal marketing authorization by the
European Commission is therefore expected within the next few weeks.
Oracea® shall be the first drug marketed by MediGene itself. The
company's currently marketed drugs (Eligard® in Europe, and
Veregen(TM)/Polyphenon® E Ointment in the USA) are marketed by
partner companies.
 
Dr. Peter Heinrich, Chief Executive Officer of MediGene AG,
commented: "A marketing authorization for Oracea® would mark the
beginning of a new era for MediGene, and we are now preparing our
first market launch of a drug. Drug commercialization in selected
European countries by our selves will enable us to profit by our
products much more, and we are also planning to enlarge MediGene's
sales portfolio step by step - both by proprietary development such
as Veregen(TM) (for which we expect to obtain the first marketing
authorization in Europe at the end of 2008), and by licensing other
products".
 
The recommendation for approval of Oracea® initially applies to
Germany, UK, Italy, Austria, Ireland, Sweden, Finland, Luxembourg,
and the Netherlands. Within the scope of the mutual recognition
procedure, MediGene is also planning to submit marketing
authorization applications in additional European countries. MediGene
plans to market Oracea® in some selected countries, and for the
remaining countries the company intends to conclude marketing
partnerships. MediGene acquired the pan-European marketing rights to
the drug from the US company CollaGenex, Inc. in 2006. Oracea® has
been successful on the US market since 2006.
 
About Oracea®: Oracea® is the first drug for systemic long-term
treatment of rosacea with inflammatory lesions. In clinical trials
Oracea® was characterized by high efficacy and safety. By its
innovative and low-dosed administration, the active substance
doxycycline (tetracycline) is released in such a way that it has an
anti-inflammatory effect without affecting the body's normal
bacteria. Therefore treatment with Oracea® led to significantly fewer
adverse effects than established tetracycline therapies. Moreover
there has been no development of any bacterial resistance during the
clinical trials. Oracea® therefore offers physicians and patients a
new therapeutic option in the treatment of rosacea.
 
About Rosacea: Rosacea is an inflammatory disease of the facial skin,
especially in the center part of the face. The onset of the disease
is usually between the age of 30 - 40, and it is a chronic, episodic
disease. The cause of rosacea is still unknown, and both genetic
predisposition and outside influences appear to be involved in the
onset of the disease. About 15 million people in Europe are affected
by rosacea.
 
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 Veregen(TM) are trademarks of MediGene AG,
Polyphenon® is a registered trademark of Mitsui Norin Co., Ltd.,
Oracea® is a registered trademark of CollaGenex Pharmaceuticals Inc.,
Eligard® is a registered trademark of QLT USA, Inc. These trademarks
may be owned or licensed in select locations only.
 
 
- 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 to have drugs on the market, which are
distributed by partner companies. The company plans to start its own
sales activities in select European countries. MediGene's drug
pipeline includes several products in clinical development, among
them two blockbuster-candidates with an estimated revenue potential
of more than one billion Euro. In addition, MediGene is active in
various research projects and possesses platform technologies for
developing active compounds. MediGene concentrates on researching,
developing and commercializing novel drugs in three therapeutic
areas: cancer, autoimmune diseases, and skin diseases.
 
 
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/ Dr. Georg Dönges, Investor Relations   
Tel.:   ++49 - 89 - 85 65 - 2946
 
 



--- End of Message ---

MediGene AG
Lochhamer Strasse 11 Martinsried / München Germany

WKN:
502090; ISIN: DE0005020903 ; Index: Prime All Share, CDAX, TECH All
Share, HDAX, MIDCAP, TecDAX;
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,
Geregelter Markt in Frankfurter Wertpapierbörse;



 
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