Pharming files GRAS notification with FDA for human lactoferrin

By E. Janene Geiss

Philadelphia, Dec. 29 - Pharming Group NV announced Thursday that it has completed its human lactoferrin filing for a Generally Recognized as Safe notification with the Food and Drug Administration.

Pharming said it has notified the FDA that its human lactoferrin is generally recognized as safe for use as an ingredient in functional foods, according to a company news release.

The filing has been reviewed by an independent scientific expert panel, officials said.

After careful evaluation of numerous safety studies performed with Pharming's human lactoferrin and published scientific data, officials said the expert panel has concluded that human lactoferrin is safe for its intended uses.

"The company is in a strong position to execute commercial agreements and is ready for a new phase of rapid corporate growth," Francis Pinto, chief executive officer of Pharming, said in the release.

Pharming, based in Leiden, The Netherlands, is developing protein products that include potential treatments for genetic disorders, specialty products for surgical indications, intermediates for various applications and food products.

The company has two products in late stage development including recombinant human C1 inhibitor for hereditary angioedema, which is in phase 3 studies, and recombinant human lactoferrin for use in functional foods.

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