Positive results of study with human lactoferrin

Nov 24 2004

Pharming Group N.V. announced today the positive results from a key study with recombinant human lactoferrin (rhLF). The Company will use these results for Generally Regarded as Safe (GRAS) registration of rhLF for nutritional applications.

The results demonstrate that rhLF can be consumed orally at high amounts with no adverse effect. Pharming has conducted the extensive animal toxicology study in cooperation with the TNO Institute for Nutrition and Food Research to observe the effect of the oral intake of rhLF. After publication of the study results, the Company will prepare its GRAS filing along with an expert opinion on use of rhLF for nutritional applications.

"I am very pleased with the positive outcome of this study with recombinant human lactoferrin, as well as the positive results in animal studies with human fibrinogen," said Dr. Francis J. Pinto, CEO of Pharming. "Based on these achievements, Pharming will consider making additional investments to accelerate the development of these innovative products."

Recently, Pharming completed initial studies in animal models with recombinant tissue sealant / fibrinogen (rhTS / rhFIB). The results of these studies indicate that rhTS / rhFIB is effective in stopping bleedings and may provide advantages over commercially available plasma fibrin sealants. The Company has started licensing discussions with several parties to accelerate commercial production of these products.

Human lactoferrin is a natural protein that helps to fight and prevent infections and strengthens the defense system of the human body. The protein is present in substantial quantities in mother's milk and plays an important role in the defense system of infants. The protein is also present in various body fluids and continues to play an important role against a wide range of bacterial, fungal and viral pathogens in adults.

Pharming is developing recombinant human lactoferrin (rhLF) as a nutraceutical and intermediate while evaluating applications of the product for the pharmaceutical market. Pharming has demonstrated that rhLF is safe, effective and comparable to the natural hLF. Pharming plans to file for Generally Regarded as Safe (GRAS) status for rhLF and commercialize the product for nutritional applications.