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Pharming Group N.V.

Pharming Group N.V.

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Publicatie datum 26 nov 2008 - 13:42
Statutaire naam Pharming Group N.V.
Titel PHARMING ANNOUNCES POSITIVE RESULTS FROM PRODARSAN® PHASE I STUDY
Bericht Leiden, The Netherlands, November 26, 2008. Biotech company Pharming Group NV (“Pharming”) (NYSE Euronext: PHARM) announced today that its wholly owned subsidiary DNage has successfully completed a Phase I trial, in healthy human volunteers, to evaluate the pharmacokinetics and tolerability of Prodarsan®. In this Phase I study, single and multiple escalating doses were administered to healthy volunteers. The data obtained show that Prodarsan® is safe and well tolerated when used in dosages that have earlier shown to yield positive effects in preclinical studies. Since Prodarsan® will be used as an oral, liquid formulation the effects of food intake on absorption and elimination of the product were also investigated. Based on these data, combined with data generated in the preclinical program, an oral dosing scheme has been established that will be used in clinical studies with patients suffering from Cockayne Syndrome. Cockayne Syndrome, the initial target of Prodarsan®, is a rare genetic disease in which children suffer from accelerated (or premature) ageing, while developing severe ageing diseases. Premature ageing is a group of genetic diseases which manifests in several forms that are genetically and clinically similar although not identical. Dependent on the specific form of the disease, patients have a significantly reduced life expectancy and exhibit many ageing-related diseases early on in their lives. Quality of life for these patients is seriously impaired. Cockayne Syndrome is one of the more common forms of premature ageing and is characterized, amongst others, by growth failure, mental retardation, eye abnormalities and a reduced life expectancy. Currently, no effective therapy for Cockayne Syndrome is available. Pharming has demonstrated that Prodarsan® has significant beneficial effects in animal models for Cockayne Syndrome. Dr. Rein Strijker, General Manager of DNage and member of the Board of Management of Pharming, commented: “Prodarsan®, as th

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