Pharming receives Japanese patent on recombinant human lactoferrin

12/08/05 The Netherlands, Pharming Group N.V., a biotechnology company, has announced that it has been granted a patent on recombinant human lactoferrin (rhLF) from the Japanese Patent Office.

The Japanese patent granted covers the production and purification of recombinant human lactoferrin with Pharming technology as well as its use in food formulations. In Japan, bovine lactoferrin is currently used as an additive in food products as well as a nutritional supplement and Japan represents a significant geographic market for recombinant human lactoferrin.

Pharming completed a key study with recombinant human lactoferrin that demonstrates that the oral application of rhLF is safe. The publication of the study results and the opinion of an expert committee on rhLF are key milestones for a Generally Recognized as Safe (GRAS) filing with the US Food and Drug Administration (FDA). Pharming has submitted the study results with rhLF for publication and is convening an expert committee to provide an opinion on the results obtained with rhLF.

In addition, the Company announced the publication of a paper confirming the virtually identical structure of Pharming’s recombinant human lactoferrin and lactoferrin found in the human body. The paper has been published in the scientific journal Transgenic Research and will support the GRAS filing for rhLF with the FDA.

Human lactoferrin is a natural protein that helps to fight and prevent infections 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 has demonstrated that rhLF is safe, effective and comparable to lactoferrin found in the human body. Pharming is preparing a filing for Generally Regarded as Safe (GRAS) status for rhLF with the US Food and Drug Administration (FDA) and plans to commercialize the product for nutritional applications.

Pharming Group N.V. is developing innovative protein therapeutics for unmet medical needs. The Company’s products include potential treatments for genetic disorders, specialty products for surgical indications, and intermediates for various applications. Pharming’s lead product (recombinant human C1 inhibitor) for hereditary angioedema is in Phase III of clinical development. The advanced technologies of the Company include innovative platforms for the production of protein therapeutics, as well as technology and processes for the purification and formulation of these products.