Pharming confirms interaction with US FDA for Rhucin
(Thomson Reuters ONE) - Leiden, The Netherlands, December 9, 2009. Biotech company PharmingGroup NV ("Pharming") (NYSE Euronext: PHARM) today confirmed itsinteractions in a pre-BLA meeting with the US Food and DrugAdministration (FDA) on a proposed marketing application (BLA orBiologics License Application) to obtain marketing approval forRhucin for the treatment of acute attacks of HAE (HereditaryAngioedema).In a pre-BLA meeting, FDA and the sponsor can discuss the outline ofthe application in advance of submission to avoid potential pitfallsin the review process. The results of these meetings areconfidential. Based on the outcome, Pharming will determine its nextsteps on the path to market approval and will update the market onthe process as soon as public information becomes available. Moreinformation can be found on http://www.fda.gov.In the USA, biological products are approved for marketing under theprovisions of the Public Health Service (PHS) Act. The Act requires afirm which manufactures a biologic for sale in interstate commerce tohold a license for the product. To commercialize the new biologicalproduct in the USA, the FDA needs to approve a Biologics LicenseApplication (BLA). A BLA is a submission that contains specificinformation on the manufacturing processes, chemistry, pharmacology,clinical pharmacology and the medical affects of the biologicproduct. If the information provided meets FDA requirements, theapplication is approved and a license is issued allowing the companyto market the product.About Pharming Group NVPharming Group NV is developing innovative products for the treatmentof genetic disorders, ageing diseases, specialty products forsurgical indications, and nutritional products. Pharming's leadproduct Rhucin® for acute attacks of Hereditary Angioedema has passedclinical development stage and the Market Authorization Applicationis under review with EMEA. Prodarsan® is in early stage clinicaldevelopment for Cockayne Syndrome and lactoferrin for use in foodproducts The advanced technologies of the Company include innovativeplatforms for the production of protein therapeutics, technology andprocesses for the purification and formulation of these products, aswell as technology in the field of DNA repair (via DNage). Additionalinformation is available on the Pharming website,http://www.pharming.com.This press release contains forward looking statements that involveknown and unknown risks, uncertainties and other factors, which maycause the actual results, performance or achievements of the Companyto be materially different from the results, performance orachievements expressed or implied by these forward lookingstatements.Contact:Ms. Marjolein van Helmond, Pharming Group NV, T: +31 (0)71 52 47 431or +31 (0)6 109 299 54http://hugin.info/132866/R/1359956/331651.pdfThis announcement was originally distributed by Hugin. The issuer is solely responsible for the content of this announcement.
Datum: 09.12.2009 - 08:00 Uhr
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