MediGene AG
(Frankfurt, Prime
Standard: MDG)
announced that the
European Commission has acted on the
recommendation by the European regulatory
authority EMEA of April 2008, and granted
marketing authorization for the drug Oracea® for
the treatment of rosacea. The regulatory
authorities in the individual countries are to
implement this decision within 30 days by
granting domestic approvals.
The first domestic approvals for Oracea® will be
granted in Germany, UK, Italy, Austria, Ireland,
Sweden, Finland, Luxembourg, and the
Netherlands. Oracea® has been successful on the
US market since 2006. MediGene is currently
negotiating on this drug with potential buyers
and marketing partners. MediGene acquired the
pan-European marketing rights to the drug from
the US company, CollaGenex, Inc., in 2006. On
April 11, 2008, Galderma Pharma S.A., a global
specialty pharmaceutical company focused on
dermatology, announced that its U.S. holding
company, Galderma Laboratories, Inc., completed
its acquisition of CollaGenex Pharmaceuticals,
Inc. As a result of the transaction, CollaGenex
has become a wholly owned subsidiary of Galderma
Laboratories.
About Oracea®: Oracea® is the first approved
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 representing the opinion of MediGene
as of the date of this release. The actual
results achieved by MediGene may differ
significantly from the statements made herein.
MediGene is not bound to update any of these
forward-looking statements. MediGeneÒ is a
trademark of MediGene AG, this trademark is
licensed in select locations only. Oracea® is a
registered trademark of CollaGenex
Pharmaceuticals Inc.
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 being distributed by
partner companies. Another drug candidate has
just received official recommendation for
marketing authorization by the EMEA. MediGene
has several drug candidates in clinical
development. Moreover, the company has projects
in research and pre-clinical development and
possesses innovative platform technologies.
MediGene concentrates on researching and
developing 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. Georg Dönges, Public
Relations, Tel.: ++49 - 89 - 85 65 - 3317
Dr. Michael Nettersheim / Dr. Georg Dönges,
Investor Relations, Tel.: ++49 - 89 - 85 65 -
2946