SOURCE: Pharming Group N.V.

April 23, 2008 05:59 ET

Pharming starts clinical program in ageing diseases

LEIDEN, NETHERLANDS--(Marketwire - April 23, 2008) -

Prodarsan® enters Phase I study for treatment of premature ageing

Leiden, The Netherlands, April 23, 2008. Biotech company Pharming Group NV ("Pharming") (NYSE Euronext: PHARM) announced today that its wholly owned subsidiary DNage has started a Phase I clinical study to evaluate the pharmacokinetics and tolerability of Prodarsan® in humans.

Premature ageing, the primary target of Prodarsan®, is a group of rare genetic diseases which manifests itself in several forms that are genetically and clinically similar although not identical. Dependent on the specific form of the disease, patients have a strongly reduced life expectancy and exhibit many ageing-related diseases early on in their lives. There is currently no effective therapy available for these patients.

Pharming has demonstrated that Prodarsan® as an oral, liquid formulation has significant effects in animal models for Cockayne Syndrome ("CS"). CS 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. The positive effects of Prodarsan® in preclinical testing on life expectancy in general and more specifically on the eye abnormalities are promising for further development of the product and its testing in humans.

The Phase I trial that is now being conducted consists of a combined single and multiple dose escalating clinical study in healthy volunteers. By studying the pharmacokinetics and tolerability of Prodarsan® and the effects of food intake on the absorption and elimination of the product, an oral dosing scheme will be determined that targets the pharmacological effective concentration range effectively. It is expected that following a successful completion of this trial the first clinical studies in patients will start later in 2008.

Prodarsan® is a defined combination of small molecules which is being developed to delay the progression of age-related diseases. Prodarsan® is thought to act by reducing DNA-damage accumulation, which has recently been established as an important element in ageing and the development of ageing related pathology. For instance, patients that suffer from premature ageing usually have a genetic defect that results in insufficient DNA-repair. DNage had previously also shown that defected DNA-repair in animals leads to the development of ageing related diseases such as Osteoporosis and Neurodegeneration.

About Pharming Group NV

Pharming Group NV is developing innovative products for the treatment of genetic disorders, aging diseases, specialty products for surgical indications, intermediates for various applications and nutritional products. Pharming has two products in late stage development - Rhucin® (recombinant human C1 inhibitor) for hereditary angioedema and human lactoferrin for use in food products. The advanced technologies of the Company include innovative platforms for the production of protein therapeutics, technology and processes for the purification and formulation of these products, as well as technologies in the field of tissue repair (via its collaboration with NovaThera) and DNA repair (via its acquisition of DNage BV). Additional information is available on the Pharming website, and on

This press release contains forward looking statements that involve known and unknown risks, uncertainties and other factors, which may cause the actual results, performance or achievements of the Company to be materially different from the results, performance or achievements expressed or implied by these forward looking statements. The press release also appears in Dutch. In the event of any inconsistency, the English version will prevail over the Dutch version.


Rein Strijker (NL)
Pharming Group NV
T: +31 (0)71 524 7400

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