SOURCE: Pharming Group N.V.

October 22, 2009 12:48 ET

Pharming recombinant human C1 inhibitor: Results in pre-clinical ischaemic reperfusion model confirm potential for new indications

LEIDEN, NETHERLANDS--(Marketwire - October 22, 2009) - Biotech company Pharming Group NV ("Pharming" or "the Company") (NYSE Euronext: PHARM) announced today publication of a preclinical study showing the benefit of using recombinant human C1 inhibitor (rhC1INH) in ischemic brain injury. The results support the potential for development of the product for treatment of so-called ischemia-reperfusion injuries, in order to improve the outcome in a variety of indications, such as Acute Myocardial Infarction (AMI), Stroke and Delayed Graft Function (DGF) after Organ Transplantation.

Because of its multiple anti-inflammatory effects, C1 inhibitor (C1INH) may be an effective drug for the treatment and prevention of ischemia-reperfusion injury. In a preclinical stroke model, Pharming explored the efficacy of rhC1INH on ischemic brain injury in comparison with plasma derived C1 inhibitor (pdC1INH). The results show that rhC1INH markedly reduced cerebral damage when administered up to as late as 18 hours after the ischemic episode. Furthermore, rhC1INH appeared to be remarkably more effective than pdC1INH in reducing the size of the brain infarcts. An explanation for this difference between rhC1INH and plasma derived C1INH is that, unlike plasma derived C1INH, rhC1INH binds to mannose binding lectin (MBL) and attenuates the inflammatory damage mediated by this protein during ischemia-reperfusion injury.

"By reducing the tissue damage in ischemic injuries, Pharming's rhC1INH product could set a new standard in the treatment of blockbuster indications such as DGF, AMI and Stroke," said Dr. Bruno Giannetti, Chief Operations Officer of Pharming. "The results of the study are particularly promising because the window of opportunity to initiate treatment was 18 hours compared to less than 3 hours for plasma derived product, and this time window is of critical importance for clinical applications."

Pharming performed the study in collaboration with researchers from the Mario Negri Institute for Pharmacological Research in Milan, Italy. The results are published by Dr De Simoni (Annals of Neurology 2009 Sep;66(3):332-42) The findings of these studies also form the basis for a patent application of Pharming.

Pharming is currently focussing on the development of rhC1INH for the treatment of acute attacks of hereditary angioedema (Rhucin®). This includes all types of attacks, i.e. abdominal attacks, facial attacks and peripheral attacks. Pharming submitted its Marketing Authorization Application (MAA) for Rhucin to EMEA in September 2009. According to the standard timetable of the Centralized Procedure, Pharming may expect the adoption of the final CHMP opinion within a total of 210 days review time (excluding any clock-stops), which is the second half of next year. More information on this procedure can be found on www.emea.europa.eu.

About transplantation and ischemia In the United States alone, over 79,000 patients are waiting for an organ transplant. 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 Antibody Mediated Rejection (AMR), which causes acute loss of the transplant, and DGF, which results from ischemia-reperfusion injury of the transplanted kidney, and is associated with an increased rejection rate and graft failure.

Ischemia occurs when the blood supply to a tissue is interrupted. Restoration of blood supply is a logic treatment but has to be applied early as it otherwise induces severe inflammatory damage to the jeopardized tissue. Ischemia-reperfusion injury is involved in various diseases including cardiovascular diseases and kidney transplantation.

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® for acute attacks of Hereditary Angioedema has passed clinical development stage and the Market Authorization Application is under review with EMEA. Prodarsan® is in early stage clinical development for Cockayne Syndrome and 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.


Contact:
Ms. Marjolein van Helmond, Pharming Group NV
T: +31 (0)71 52 47  431
or +31 (0)6 109 299 54


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