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Fovea Pharmaceuticals Receives Orphan Drug Designation from EC for RdCVF for the Treatment of Retinitis Pigmentosa
Date:1/7/2008

PARIS, Jan. 7 /PRNewswire/ -- Fovea Pharmaceuticals SA, which, last December 2007, raised $44M in a Series B financing, today announced that its product, Recombinant human rod-derived cone viability factor (rh-RdCVF), has received designation as Orphan Medicinal Product from the European Commission, following the positive opinion from the European Agency for the Evaluation of Medicinal Products (EMEA) Committee for Orphan Medicinal Product (COMP) for the treatment of retinitis pigmentosa, a genetic disease leading to progressive loss of vision. Fovea is currently conducting pre-clinical studies of RdCVF and has demonstrated efficacy in animal model of the disease.

Orphan drug designation would entitle Fovea to exclusive marketing rights in the European countries for ten years should Fovea be the first company to receive marketing approval for this type of therapeutic drug product. In addition, the designation would allow Fovea to apply for research funding, tax credits for certain research expenses, and protocol assistance. Similar orphan drug designation is currently being assessed in the USA by the Food and Drug Administration (FDA).

"We are pleased to have received this orphan drug designation for RdCVF in the treatment of retinitis pigmentosa," said Bernard Gilly, Chairman and Chief Executive Officer of Fovea. "This designation is a recognition of the quality of our work and will also provide us with financial and regulatory benefits in addition to market exclusivity."

In a study on animal model of the disease performed at INSERM U592 in Paris (Pr. Jose Sahel's team) RdCVF was shown to improve the survival and the functionality of retinal cone cells that are responsible for central vision and that are degenerating in patients suffering from this disease. Fovea is conducting further studies to produce RdCVF and plans to start clinical trials in 2009.

About Retinitis Pigmentosa

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SOURCE Fovea Pharmaceuticals SA
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