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A new era for MediGene: first drug to be marketed by the company itself
Munich, Germany | April 25, 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(R) 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(R) shall be the first drug marketed by MediGene itself. The company's currently marketed drugs (Eligard(R) in Europe, and Veregen(TM)/Polyphenon(R) 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(R) 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(R) 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(R) 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(R) has been successful on the US market since 2006.
About Oracea(R)
Oracea(R) is the first drug for systemic long-term treatment of rosacea with inflammatory lesions. In clinical trials Oracea(R) 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(R) 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(R) 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.
SOURCE: MediGene AG |
