Community

Advertising Opportunities

 Biotechnology Europe Programs

 Resources

Biotechnology Europe Community

Feedback

Contact

Biotechnology Europe Advantages

Advertising Opportunities on Biotechnology Europe

Sponsorship Opportunities on Biotechnology Europe

 

Post a Job on Biotechnology Europe

Post a Company Profile on Biotechnology Europe

Post a News on Biotechnology Europe

Post an Event on Biotechnology Europe

Post a Product on Biotechnology Europe

Post a Publication on Biotechnology Europe

Post a Technology on Biotechnology Europe

Post a Resume on Biotechnology Europe

Terms of Business

Imprint

Privacy Policy

FAQ

Subscribe Newsletter

 

MediGene News

   

 

 

   
     

   
 
   
   
   
   
   
   
   
   
   
   
   
   
   
   
   
   

post your news I subscribe newsletter I contact us

 
 
     

 

2008 I 2007 I

European Commission Grants Marketing Authorization for MediGene's Drug Oracea®

29th July 2008 Martinsried/Munich


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

 

 

 

 
 MediGene AG News I add this page to your favorites

17.07.2008 MediGene exercises option for Anti-L1 Monoclonal Antibody and continues collaboration with DKFZ (German Cancer Research Center)

 

16.07.2008 MediGenes Annual Shareholders' Meeting Elects Two New Supervisory Board Members

 

15.07.2008 MediGene Publishes Update on RhuDex® Incident

 

 08.07.2008 MediGene puts clinical phase I study with RhuDex® on hold

 

24.06.2008 MediGene Achieves Positive Results with RhuDex® in Clinical Phase IIa Trial

 

02.06.2008 MediGene Focuses its Strategy on Oncology and Immunology

 

14.03.2008 MediGene to Present at the Cowen and Company 28th Annual Health Care Conference in Boston

 
  13.03.2008 MediGene AG Announces Consolidated Result for the Year
 

07.01.2008 MediGene Focuses its Research Activities and Considers External Financing for mTCR Program

 

 
 
 
Google
 
 
 
 I back I top I  

 

 

                                                                

office@biotechnology-europe.com I website@biotechnology-europe.com I service@biotechnology-europe.com

 


 

Advertising Opportunities on Biotechnology Europe

Sponsorship Opportunities on Biotechnology Europe

About Biotechnology Europe

Post a Job on Biotechnology Europe

Post a Company Profile on Biotechnology Europe

Post a News on Biotechnology Europe

Post an Event on Biotechnology Europe

Post a Product on Biotechnology Europe

Post a Publication on Biotechnology Europe

Post a Technology on Biotechnology Europe

Post a Resume on Biotechnology Europe


 

Biotechnology Europe Your Partner in Bioscience and Business

  Central Internet Platform and Service Company For The Life Sciences in Europe

Imprint I Site map I Privacy Policy I Contact us I About us I Copyright BIOTECHNOLOGY WORLD  All rights reserved