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Pharming Group N.V.
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Publicatie datum
04 aug 2006 - 07:30
Statutaire naam
Pharming Group N.V.
Titel
PHARMING ANNOUNCES FIRST HALF 2006 RESULTS-Reports on solid cash position and progress on rhC1INH submissions
Bericht
Leiden, The Netherlands, August 4, 2006. Biotech company Pharming Group NV (“Pharming” or “the Company”) (Euronext: PHARM) (PHARM.AS) announced today its results for the first half (HY1) of 2006 and second quarter ended June 30, 2006. The Company reports on its solid financial position and progress with regulatory submissions for recombinant human C1 inhibitor (rhC1INH).
Key Developments
Financial
? Cash position of € 41.6 million (including marketable securities) as of June 30, 2006
? € 17.1 million in equity to develop rhC1INH for new indications and other corporate purposes
? US $15 million in cash and US $5 million in equity raised from affiliates of Paul Royalty Fund II, LP (“Paul Royalty Fund”)
? Inventories increased to € 7.7 million from € 3.9 million in preparation for rhC1INH launch
? Total costs and expenses were € 8.1 million in HY1 2006 compared to € 8.8 million in HY1 2005
? Net loss of € 8.1 million in HY1 2006 compared to € 8.2 million in HY1 2005
Products
? Marketing Authorization Application (MAA) for rhC1INH submitted to the European Medicines Agency (EMEA) for the treatment of acute attacks of hereditary angioedema (HAE)
? Discussion with regulatory authorities ongoing for the compassionate use of rhC1INH
? Fast Track designation on rhC1INH for the treatment of HAE from the US Food and Drug Administration (FDA)
? Orphan Drug designations for rhC1INH for treatment of two additional indications (Delayed Graft Function after solid organ transplantation and Capillary Leakage Syndrome) beyond HAE granted by the FDA
? Filing on human lactoferrin (hLF) for Generally Recognized as Safe (GRAS) notification under review with the FDA
Corporate
? Strategic agreement with Paul Royalty Fund on the development of rhC1INH
? Acquisition of DNage BV (“DNage”) pending the outcome of the appeal at the Enterprise Section in Amsterdam
? Pharming added to the Euronext Amsterdam Midkap Index (AMX) as of March 2, 2006
“Pharming has achieved significant milestones
Datum laatste update: 06 oktober 2024