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news.MediGene has announced that the European Medicines Agency Committee for Medicinal Products for Human Use has concluded the approval procedures for Oracea for the treatment of rosacea by issuing a positive opinion.
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The formal marketing authorization by the European Commission is expected within the next few weeks. Oracea shall be the first drug marketed by MediGene itself.
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.
Peter Heinrich, CEO of MediGene, said: “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 (for which we expect to obtain the first marketing authorization in Europe at the end of 2008), and by licensing other products.”