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Pharming updates on ongoing call of first tranche of EUR10 million equity working capital facility and study 1310
MarketwireLEIDEN, THE NETHERLANDS -- (Marketwire) -- 08/13/12 -- Biotech company Pharming Group NV("Pharming" or "the Company") (NYSE Euronext: PHARM) today announcesthat theinvestors have increased the first call under the facility by 13,000,000sharesfrom 32,808,442 to 45,808,442.
Under the first call of 15,088,368 shares made by the Company asannounced onAugust 8, 2012, the individual investors have an option to purchasethat islimited to up to 600% of these 15,088,368 shares during the 15 tradingdays ofthis call. The investors have now called for another 13,000,000shares inaddition to 17,720,074 shares previously issued under their option.Followingthe issue of these 13,000,000 shares as per August 13, 2012, thenumber ofoutstanding shares increases from currently 757,057,118 shares to770,057,118shares.
Pharming's CEO, Sijmen de Vries commented: "We are very pleasedabout thedevelopment of this call as it supports our ongoing discussions withpotentialpartners and investors as part of our strategic review. At the same time,we aremoving closer to the conclusion of our US pivotal Phase III study (Study1310);as of today, 62 of the 75 patients were either treated for a subsequentattackof HAE or reached the Day 90 endpoint of the study."
RUCONEST Phase III Study
Pharming is conducting a Phase III clinical study with RUCONEST underaSpecial Protocol Assessment (SPA) that is intended to support thesubmission ofa Biologics License Application (BLA) to the U.S. Food and DrugAdministration(FDA). RUCONEST is being evaluated for the treatment of acute attacks ofangioedema in patients with HAE in an international, multicenter,randomized,placebo-controlled Phase III study at a dosage strength of 50 U/kg with aprimary endpoint of time to beginning of relief of symptoms. Santarus haslicensed certain exclusive rights from Pharming to commercialize RUCONESTinNorth America for the treatment of acute attacks of HAE and other futureindications. Under the terms of the license agreement, a $10 millionmilestoneis payable to Pharming upon successful achievement of the primary endpointofthe Phase III clinical study. The study is expected to be completed by theendof the third quarter of 2012.
About RUCONEST and Hereditary Angioedema
RUCONEST (INN conestat alfa) is a recombinant version of the humanprotein C1inhibitor (C1INH). RUCONEST is produced through Pharming's proprietarytechnology in milk of transgenic rabbits and is approved in Europe fortreatmentof acute angioedema attacks in patients with HAE. RUCONEST is aninvestigational drug in the U.S. and has been granted orphan drugdesignationfor the treatment of acute attacks of HAE, a genetic disorder in which thepatient is deficient in or lacks a functional plasma protein C1 inhibitor,resulting in unpredictable and debilitating episodes of intense swelling oftheextremities, face, trunk, genitals, abdomen and upper airway. The frequencyandseverity of HAE attacks vary and are most serious when they involvelaryngealedema, which can close the upper airway and cause death by asphyxiation.According to the U.S. Hereditary Angioedema Association, epidemiologicalestimates for HAE range from one in 10,000 to one in 50,000 individuals.
About Pharming Group NV
Pharming Group NV is developing innovative products for the treatment ofunmetmedical needs. RUCONEST is a recombinant human C1 inhibitor approvedfor thetreatment of angioedema attacks in patients with HAE in all 27 EU countriesplusNorway, Iceland and Liechtenstein, and is distributed in the EU by SwedishOrphan Biovitrum (OMX: SOBI). RUCONEST is partnered with Santarus,Inc(NASDAQ: SNTS) in North America where the drug is undergoing Phase IIIclinicaldevelopment. The product is also being evaluated for follow-on indicationsinthe areas of transplantation and reperfusion injury. The advancedtechnologiesof the Company include innovative and validated platforms for theproduction ofprotein therapeutics, technology and processes for the purification andformulation of these products. A feasibility study, using the validatedtransgenic rabbit platform, aimed at the development of recombinant FactorVIIIfor the treatment of Haemophilia A is underway with partner Renova Life,Inc.Additional information is available on the Pharming website,www.pharming.com.To download the Pharming Group Investor Relations App, click here.
This press release contains forward looking statements that involveknown andunknown risks, uncertainties and other factors, which may cause theactualresults, performance or achievements of the Company to be materiallydifferentfrom the results, performance or achievements expressed or implied bytheseforward looking statements.
Press release (PDF):http://hugin.info/132866/R/1633420/524195.pdf
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Source: Pharming Group N.V. via Thomson Reuters ONE[HUG#1633420]
ContactSijmen de VriesCEOT: +31 (0)71 524 7400Karl KeeganCFO:T: +31 (0)71 524 7400FTI ConsultingJulia Phillips/ John DineenT: +44 (0)207 269 7193Source: Pharming Group N.V.
