SOURCE: Pharming Group N.V.

December 09, 2009 02:09 ET

Pharming Confirms Interaction With US FDA for Rhucin

LEIDEN, NETHERLANDS--(Marketwire - December 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.

In the USA, biological products are approved for marketing under the provisions of the Public Health Service (PHS) Act. The Act requires a firm which manufactures a biologic for sale in interstate commerce to hold a license for the product. To commercialize the new biological product in the USA, the FDA needs to approve a Biologics License Application (BLA). A BLA is a submission that contains specific information on the manufacturing processes, chemistry, pharmacology, clinical pharmacology and the medical affects of the biologic product. If the information provided meets FDA requirements, the application is approved and a license is issued allowing the company to market the product.

About Pharming Group NV

Pharming Group NV is developing innovative products for the treatment of genetic disorders, ageing diseases, specialty products for surgical indications, and nutritional products. Pharming's lead product Rhucin® for acute attacks of Hereditary Angioedema has passed clinical development stage and the Market Authorization Application is under review with EMEA. Prodarsan® is in early stage clinical development for Cockayne Syndrome and lactoferrin for use in food products The advanced technologies of the Company include innovative platforms for the production of protein therapeutics, technology and processes for the purification and formulation of these products, as well as technology in the field of DNA repair (via DNage). 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.

Contact:

Ms. Marjolein van Helmond
Pharming Group NV
T: +31 (0)71 52 47 431
or +31 (0)6 109 299 54

Press Release PDF: http://hugin.info/132866/R/1359956/331651.pdf

This announcement was originally distributed by Hugin. The issuer is solely responsible for the content of this announcement.



Copyright © Hugin AS 2009. All rights reserved.

Contact Information