Pharming Group NV's pre-BLA meeting with the FDA for Rhucin

Dec 9 2009

Biotech company Pharming Group NV ("Pharming") (NYSE Euronext: PHARM) today confirmed its interactions in a pre-BLA meeting with the US Food and Drug Administration (FDA) on a proposed marketing application (BLA or Biologics License Application) to obtain marketing approval for Rhucin for the treatment of acute attacks of HAE (Hereditary Angioedema).

In a pre-BLA meeting, FDA and the sponsor can discuss the outline of the application in advance of submission to avoid potential pitfalls in the review process. The results of these meetings are confidential. Based on the outcome, Pharming will determine its next steps on the path to market approval and will update the market on the process as soon as public information becomes available. More information can be found on http://www.fda.gov.