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Pharming Group N.V.

Pharming Group N.V.

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Publicatie datum 14 jun 2006 - 08:06
Statutaire naam Pharming Group N.V.
Bericht Leiden, The Netherlands, June 14, 2006. Biotech company Pharming Group NV (“Pharming” or “the Company”) (Euronext: PHARM) announced today it has received orphan drug designations for recombinant human C1 inhibitor (rhC1INH) from the Food and Drug Administration (FDA). The Company has obtained designations on rhC1INH for two separate disease indications - the prevention and/or the treatment of Delayed Graft Function (DGF) after solid organ transplantation and the treatment of Capillary Leakage Syndrome (CLS). Over 25,000 solid organs were transplanted in the US in 2005, including kidney, liver, lung and heart transplants. Delayed Graft Function is a common complication affecting all solid organs in the post-transplant period. DGF results in significant morbidity and mortality from early graft dysfunction and from decreased long-term graft survival. The condition also prolongs hospitalization and requires substitute therapies for these patients, such as dialysis or ventilatory support. DGF remains a critical unmet medical need despite improvements in immunosuppression, organ preservation, and surgical technique. C1 inhibitor has been shown in numerous models of organ transplantation to improve early graft function. Over 100,000 patients in the US develop Capillary Leakage Syndrome annually as a complication of various disease states, including bone marrow/stem cell transplantation, IL-2 therapy, sepsis, and neonatal cardiac surgery. CLS is a severe life-threatening condition characterized by excessive fluid loss into the tissue space, which can result in hemodynamic instability, pulmonary edema, ascites, and death. Current therapies for patients with CLS are limited to supportive care and treatment of the underlying condition. Previous clinical work has demonstrated that C1 inhibitor may be an effective anti-inflammatory that can control the mechanisms contributing to CLS. "Pharming’s rhC1INH product could provide new treatments for immune mediated diseases such a