SOURCE: Pharming Group N.V.

November 26, 2008 08:05 ET

Pharming announces positive results from Prodarsan® Phase I Study

LEIDEN, NETHERLANDS--(Marketwire - November 26, 2008) -

Key step in clinical program for ageing diseases

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 the first product being developed with DNage technology, is testimony to the great potential of this approach in treating diseases related to ageing in humans. The data announced today, combined with the positive effects of Prodarsan® in preclinical testing, are promising for further development of this program. In consultation with the regulatory authorities, we are determining the next steps to be taken for clinical development program for Prodarsan®. We look forward to begin testing the product in patients suffering from premature ageing in the near future. We will also apply the same principles to start tests with various other product candidates for the treatment of ageing diseases in the elderly population. The medical need for new products in the field of premature ageing, but also in more common ageing diseases such as neurodegeneration (for instance dementia), is huge. We believe that the DNage technology can contribute to innovative new approaches in this area."

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 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 has previously also shown that defective 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, ageing diseases, specialty products for surgical indications, intermediates for various applications and nutritional products. Pharming has two products in late stage development - Rhucin® 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 technology in the field of DNA repair (via DNage). Additional information is available on the Pharming website,

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.


Carina Hamaker, Investor  Voice, T:  +31 (0)6 537  499 59 or
T:  +31 (0)71 52 47 400
Julia Phillips (UK), Financial Dynamics, T: +44 (0)20 7269 7187 or
T: +44 (0)7770 827 263
Samir Singh (US), Pharming Group NV, T: +1 908 720 6224
Rein Strijker, Pharming Group NV, T: +31 (0)71 52 47 400

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