German biotechnology company MediGene says that regulators in the European union have given it the go-ahead to market Oracea to treat rosacea, a chronic inflammation of the facial skin.
The green light follows a recommendation by European Medicines Agency’s Committee for Medicinal Products in Human Use in April. The first domestic approvals for Oracea (doxycycline) will be granted in Germany, the UK, Italy, Austria, Ireland, Sweden, Finland, Luxembourg, and the Netherlands.
The Martinsried-based company acquired the European marketing rights to Oracea from CollaGenex Pharmaceuticals, which is now owned by Galderma, in 2006. It was cleared to be sold in the USA in the same year.
MediGene noted that it is currently in talks to find a partner to market Oracea in Europe after it decided not to set up its own European sales force in the field of dermatology, it added. The cause of rosacea, which especially affects the central part of the face, is still unknown, and both genetic predisposition and outside influences appear to be involved in the onset of the disease, the firm said.
About 15 million people in Europe are affected by the disease.
