LEIDEN, Netherlands, Oct. 19, 2005 (PRIMEZONE) -- Biotech company Pharming Group N.V. ("Pharming" or "the Company") (Euronext: PHARM) (PHARM.AS) announced today results from three studies which demonstrate that human lactoferrin produced by Pharming (rhLF) can be considered safe for use in functional foods. Dr. Bertjan Ziere, Senior Director at Pharming, presented the results at the VII International Conference on Lactoferrin (October 16-19, 2005) in Honolulu, Hawaii.
Pharming has performed a large panel of studies to evaluate the safety of its human lactoferrin in concordance with US regulatory guidelines for GRAS (Generally Regarded As Safe) notification. The toxicity studies conducted demonstrate that rhLF can be consumed orally at high amounts with no adverse effect. Furthermore, results from genotoxicity tests were presented showing that rhLF does not cause any damage to cells or DNA within cells. Finally, allergenicity testing revealed that rhLF is not irritating.
"We are pleased to be announcing these positive results with our rhLF at such an authoritative congress on lactoferrin," said Dr. Frans de Loos, Director of the lactoferrin project at Pharming. "The data from these studies will form the core elements of our US FDA filing for rhLF as a GRAS product for use in functional foods."
Pharming is preparing a filing on human lactoferrin for a GRAS notification. Recently, the Company formed a partnership with AgResearch for the development of rhLF. Pharming is pursuing additional partnerships to commercialize rhLF for use in functional foods.
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 food use. 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.