Leiden, The Netherlands, December 29, 2005. Biotech company Pharming Group N.V. ("Pharming" or "the Company") (Euronext: PHARM) (PHARM.AS) announced today that it has completed its human lactoferrin (hLF) filing for a Generally Recognized as Safe (GRAS) notification with the US Food and Drug Administration (FDA).
Pharming has notified the FDA that its hLF is generally recognized as safe for use as an ingredient in functional foods. Pharming's hLF GRAS notification has been reviewed by an independent scientific expert panel. After careful evaluation of numerous safety studies performed with Pharming's hLF as well as of published scientific data, the expert panel has concluded that hLF is safe for its intended uses.
"Pharming is pleased with the progress on the development of hLF," said Dr. Francis Pinto, CEO of Pharming. "The Company is in a strong position to execute commercial agreements and is ready for a new phase of rapid corporate growth."
Background on Pharming Group N.V.
Pharming Group N.V. is developing innovative protein products for unmet needs. The Company's products include potential treatments for genetic disorders, specialty products for surgical indications, intermediates for various applications and food products. Pharming has two products in late stage development - recombinant human C1 inhibitor for hereditary angioedema (Phase III) and recombinant human lactoferrin for use in functional foods. 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. Additional information is available on the Pharming website, http://www.pharming.com.
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.