Pharming Group N.V.
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Publicatie datum
30 dec 2008 - 16:34
Statutaire naam
Pharming Group N.V.
Titel
PHARMING PROVIDES BUSINESS UPDATE
Bericht
Leiden, The Netherlands, December 30, 2008. Biotech company Pharming Group NV (“Pharming” or “the Company”) (NYSE Euronext: PHARM) today provided the following business update.
Pharming continues to make progress on its product pipeline, with clinical development starting or ongoing in three indications. In 2009, the Company will focus on completing regulatory filings on Rhucin® for the treatment of Hereditary Angioedema (HAE) and further increase the number of indications being evaluated with its products to address unmet medical needs.
Rhucin® (recombinant human C1 inhibitor for the treatment of HAE): the pre-filing dialogue with EMEA has started with a regulatory dossier in final stages of readiness that contains well in excess of 300 treatments, including significant evidence on efficacy and safety in repeated use and absence of immunogenicity. A formal filing with the EMEA will be done as soon as practically possible, pending the response of the recently installed CHMP Paediatric Committee on the Rhucin® Paediatric Investigation Plan. Currently the filing is expected mid 2009. The US BLA file was recently transferred from the CDER to the CBER division of the FDA. The file is also reaching its final stage of readiness and dialogue with the CBER division is planned for 1Q 2009.
Recombinant human C1 inhibitor (rhC1INH): in addition to the investigation into efficacy and safety of rhC1INH in the treatment of antibody-mediated rejection in kidney transplants, preparations to initiate clinical investigations into reperfusion injury related rejection of kidney transplants are under way. In addition, initially pre-clinical, investigations into other reperfusion injury related indications such as myocardial infarction and additional indications, such as macular degeneration, an ophthalmological disease leading to blindness, are now also planned.
Prodarsan®: following the recently announced successful completion of a Phase I study, a full clinical Phase II/III de
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