Leiden, The Netherlands, July 02, 2012. Biotech company Pharming Group NV ("Pharming" or "the Company") (NYSE Euronext: PHARM) announced today that recombinant human C1 inhibitor (rhC1INH; RUCONEST®) has been shown to have a protective effect in a preclinical animal model of severe blood loss designed to simulate battlefield injuries.
These results can be found online here (http://journals.lww.com/shockjournal/Abstract/2012/07000/Effects_of_C1_Inhibitor_on_Tissue_Damage_in_a.14.aspx) and will be published in print in July 2012 in Shock issue 38:1.
Dr Dalle Lucca et al. found that rhC1INHreduced tissue damage in this pig based model of severe hemorrhage, the tissue damage, following hemorrhage, strongly resembles that of ischemia-reperfusion injury (IRI). These findings further support the application of rhC1INH in the prevention of IRI such as that found after transplantation, myocardial infarction, major vascular surgery and trauma. Pharming and its partners continue to be interested in the broad therapeutic area of IRI and are reviewing several of these indications for potential future clinical development.
This study was funded by the US Army Medical Research and Materiel Command.
About RUCONEST® and Hereditary Angioedema
RUCONEST® (INN conestat alfa) is a recombinant version of the human protein C1 inhibitor (C1INH). RUCONEST is produced through Pharming's proprietary technology in milk of transgenic rabbits and is approved in Europe for treatment of acute angioedema attacks in patients with HAE. RUCONEST® is an investigational drug in the U.S. and has been granted orphan drug designation for the treatment of acute attacks of HAE, a genetic disorder in which the patient is deficient in or lacks a functional plasma protein C1 inhibitor, resulting in unpredictable and debilitating episodes of intense swelling of the extremities, face, trunk, genitals, abdomen and upper airway. The frequency and severity of HAE attacks vary and are most serious when they involve laryngeal edema, which can close the upper airway and cause death by asphyxiation. According to the U.S. Hereditary Angioedema Association, epidemiological estimates 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 of unmet medical needs. RUCONEST® is a recombinant human C1 inhibitor approved for the treatment of angioedema attacks in patients with HAE in all 27 EU countries plus Norway, Iceland and Liechtenstein, and is distributed in the EU by Swedish Orphan Biovitrum (OMX: SOBI). RUCONEST® is partnered with Santarus, Inc (NASDAQ: SNTS) in North America where the drug is undergoing Phase III clinical development. The product is also being evaluated for follow-on indications in the areas of transplantation and reperfusion injury. The advanced technologies of the Company include innovative and validated platforms for the production of protein therapeutics, technology and processes for the purification and formulation of these products. A feasibility study, using the validated transgenic rabbit platform, aimed at the development of recombinant Factor VIII for the treatment of Haemophilia A is underway with partner, Renova Life, Inc. Additional information is available on the Pharming website, www.pharming.com (http://www.pharming.com/). To download the Pharming Group Investor Relations App, click here (http://itunes.apple.com/us/app/pharming-ir/id515983241?ls=1&mt=8).
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
Sijmen de Vries, CEO: T: +31 (0)71 524 7400
Karl Keegan, CFO: T: +31 (0)71 524 7400
FTI Consulting
Julia Phillips/ John Dineen, T: +44 (0)207 269 7193
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Source: Pharming Group N.V. via Thomson Reuters ONE
