Decision About European Marketing Authorization for Oracea® Postponed
* Committee of the decentralised approval procedure (CMD) refers decision to a central body of the European regulatory authorities (CHMP)
* No impact on the overall result for 2007 expected
Martinsried/Munich - July 30, 2007. MediGene AG (Frankfurt, Prime Standard: MDG) has been informed by CollaGenex Pharmaceuticals Inc., that the decision about the European marketing authorization for the drug Oracea® for the treatment of the skin disease rosacea has been postponed. The committee of the nine countries involved in the decentralised procedure (Coordination Group for Mutual Recognition and Decentralised Procedures, CMD) did not reach a unanimous decision, and therefore refers the procedure to another committee for decision-making. The Committee for Medicinal Products for Human Use (CHMP) which is responsible for centralised approval procedures in Europe will decide by simple majority vote on the marketing authorization for Oracea®. This process usually takes about six months. MediGene does not expect this development to have any impact on the forecast for the company's overall result for the financial year 2007. The annual peak sales potential for Oracea® in Europe is expected to be about 20 million Euro.
Dr. Peter Heinrich, Chief Executive Officer of MediGene AG, comments: "We believe that Oracea® meets the criteria for marketing authorization. Our partner CollaGenex Pharmaceuticals Inc. has committed to use its reasonable best efforts to achieve approval and to close the procedure successfully."
So far, marketing authorization applications for Oracea® have been submitted by the US based company CollaGenex Pharmaceuticals, Inc. in Germany, UK, Italy, Austria, Ireland, Sweden, Finland, Luxembourg, and the Netherlands. MediGene acquired pan-European marketing rights to Oracea® from CollaGenex Pharmaceuticals in 2006. In the US, Oracea® is already approved and is successful on the market since 2006.
MediGene's first drug, Eligard®, is already available on the market. Another drug, i.e. Polyphenon® Ointment obtained marketing authorization for the USA and is 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.
About Oracea®: Oracea® is the first drug for systemic short-term as well as long-term treatment of rosacea with inflammatory lesions. By the innovative and low-dosed administration form the antibiotic doxycycline is relased in such a way that it should have an anti-inflammatory effect without affecting the body's normal bacteria. Development data suggest that the characteristic side-effects of antibiotics as well as development of resistant bacteria can be widely avoided. In clinical trials in the US Oracea® showed an efficacy superior to that of placebo, and it was well tolerated.
About Rosacea: The skin disease rosacea is an inflammation of the facial skin, especially in the center part of the face. The onset of the disease is usually between the age of 40 - 50. It is a chronic, episodic disease. The cause of rosacea is still unknown. Both genetic predisposition and outside influences seem to be involved in the onset of the disease. In Europe, about 15 million people 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. MediGeneTM is a trademark of MediGene AG, Oracea® is a trademark of CollaGenex Pharmaceuticals, Inc., Polyphenon® is a trademark of Mitsui-Norin, Eligard® is a trademark of QLT, Inc.
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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 and is 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: firstname.lastname@example.org 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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