Leiden, The Netherlands, February 17, 2010. Biotech company Pharming Group NV (“Pharming” or “the Company”) (NYSE Euronext: PHARM) announced today publication of preclinical evidence that its recombinant human C1 inhibitor (rhC1INH) may play an important therapeutic role in the prevention of delayed graft function (DGF) after solid organ transplantation. The published study results further indicate the potential for the product in the treatment of ischemia-reperfusion injuries and in particular in the prevention of DGF following kidney transplantation.
Pharming’s rhC1INH significantly reduced several ischemia/reperfusion-related inflammatory processes and significantly limited tissue damage in a swine model of ischemia/reperfusion-induced renal damage. As the inflammatory processes in pigs are very similar to those in humans, these results form a clear indication of the potential of rhC1INH for treatment and prevention of ischemia tissue damage in patients.
Ischemia/reperfusion injury is the major cause of DGF in transplanted kidneys. DGF is an early sign associated with poor long-term graft function and survival. Current treatments of DGF include the use of immune suppressing agents. Much attention is also paid to prevention of DGF by continuous improvement of the transplantation procedure itself and the conditions under which the organs or tissues are stored and treated during the procedure. Because of its unique anti-inflammatory properties Pharming’s rhC1Inh may complement current transplantation procedures and current treatment of DGF.
In October 2009, Pharming announced the beneficial results of another preclinical study in the field of ischemia-reperfusion injuries, focussing on the reduction of damage following brain infarcts (stroke). Several studies in rodents indicate that the complement system plays a pivotal role in renal ischemia reperfusion injury. To date, however, limited information was available from humans and larger animals. This swine study has been supported by a research grant from Pharming and was performed by researchers from the University of Bari, Italy. The results are published in the American Journal of Pathology Feb 2010; 176(4) by Dr Giuseppe Castellano and Professor Giuseppe Grandaliano from the University of Bari.
Dr. Castellano commented: “DGF is an important medical problem. In the EU, each year approximately 35,000 organs are transplanted. These procedures are costly and patients often have to wait a long time before transplantation can be performed. Further improvement of short-term and long-term outcomes will, therefore, provide a valuable medical and economical benefit. The results of our recent study are very promising in this regard.”
Pharming’s rhC1INH has Orphan Medicinal Product designation from the European Medicines Agency for prevention of DGF after solid organ transplantation. This status is granted to a product for which it is made plausible that it will have a positive therapeutic effect on a disease or condition which is relatively rare in the European Union and provides incentives for research, development and marketing, in particular by granting exclusive marketing rights for a ten-year period. Pharming intends to initiate a clinical study in patients at increased risk for DGF later this year.
About transplantation
In the United States alone, over 79,000 patients are waiting for an organ transplant (35,000 in the EU). Each month, nearly 3,000 new patients are added to this waiting list. However, only 25,000 solid organs are available and transplanted each year, including kidney, liver, lung and heart transplants. In addition, complications may arise following organ transplantation, such as DGF and Antibody Mediated Rejection (another complication of transplantation under clinical investigation with Pharming’s rhC1INH).
About Pharming Group NV
Pharming Group NV is developing innovative products for the treatment of genetic disorders, ageing diseases, specialty products for surgical indications, and nutritional products. Pharming’s lead product Rhucin® has completed clinical development for acute attacks of Hereditary Angioedema and a Market Authorization Application is under review with the EMA. Prodarsan® is in early stage clinical development for Cockayne Syndrome and human lactoferrin for use in food products The advanced technologies of the Company include innovative platforms for the production of protein therapeutics, technology and processes for the purification and formulation of these products, as well as technology in the field of DNA repair (via DNage). Additional information is available on the Pharming website, http://www.pharming.com.
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.
