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Pharming Group N.V. (PINKSHEETS: PHGUF) Important step for recombinant fibrinogen and biomaterials program
Leiden, The Netherlands, June 25, 2008. Biotech company Pharming Group NV ("Pharming" or "the Company") (NYSE Euronext: PHARM) announced today that it has acquired an exclusive sub-license to key patents and technology on recombinant fibrinogen from GTC Biotherapeutics Inc ("GTC"). These rights enable Pharming to accelerate pharmaceutical development of recombinant human fibrinogen (rhFIB) and stimulate medical device development through its biomaterials program.
Pharming has obtained exclusive licenses on recombinant fibrinogen for all indications in various territories, including North America, Europe and Japan. The licenses are to recently issued patents owned by the American Red Cross, Virginia Tech Intellectual Properties Inc and the University of North Carolina on the production of recombinant fibrinogen in milk of transgenic animals which are licensed to GTC from ProGenetics, LLC. The license agreement includes an upfront payment to GTC of approximately € 350,000 (US$ 550,000) and a royalty on commercial sales of rhFIB. Pharming already owns several additional patents and licenses for recombinant fibrinogen and recombinant tissue sealant compositions. The acquisition of the license from GTC further broadens and strengthens Pharming's position in this field.
Pharming has a development program for recombinant human fibrinogen as a replacement therapy for genetic and acquired deficiencies of fibrinogen. The existing market size for fibrinogen deficiencies is estimated to be over USD 500 million in the developed world. In addition to the deficiency market, rhFIB has the potential as a pharmaceutical product to address the significantly larger market of traumatic and surgical bleeding in excess of USD 1 billion. Current standard of care in the US for patients deficient in fibrinogen is the use of cryoprecipitate, which is composed mainly of plasma derived fibrinogen. In certain European countries, a partially purified plasma fibrinogen product is marketed.
Pharming has successfully produced high levels of rhFIB using its production technology. This was a technical breakthrough given the biochemical complexity of the fibrinogen molecule consisting of several subunits folded together in fixed ratios. In laboratory tests and initial animal studies, rhFIB has been demonstrated to be virtually identical in structure and function to plasma fibrinogen.
Bruno Giannetti, Chief Operations Officer, commented: "Securing the patent rights is important for the development of recombinant human fibrinogen, a key part of our product portfolio. We can now accelerate development of our fibrinogen product for pharmaceutical use and establish partnerships for medical device development. Pharming has already provided rhFIB for evaluation to several device manufacturers and research institutions to facilitate novel product development for various applications. Over the last few years, the Company has been building a program on biomaterials through collaborations with the BioMedical Materials consortium (BMM) in The Netherlands, NovaThera Ltd, the US Army and other institutions."
About recombinant human fibrinogen (rhFIB) Human fibrinogen is a natural human plasma protein involved in blot clotting. Deficiency or low levels of fibrinogen can result in uncontrolled bleeding, as can occur in case of trauma, surgery, liver disease, sepsis and cancer. Pharming is developing recombinant human fibrinogen (rhFIB) as a replacement therapy for patients with genetic and acquired deficiencies of fibrinogen. The existing market size for fibrinogen deficiencies is estimated to be over USD 500 million in the developed world. In addition to the deficiency market, rhFIB has the potential as a pharmaceutical product to address the significantly larger market of traumatic and surgical bleeding in excess of USD 1 billion. In addition to pharmaceutical development of rhFib, Pharming will pursue partnerships with medical device manufacturers on rhFIB to build further value for its biomaterial portfolio.
About Pharming Group NV Pharming Group NV is developing innovative products for the treatment of genetic disorders, aging diseases, specialty products for surgical indications, intermediates for various applications and nutritional products. Pharming has two products in late stage development - Rhucin® (recombinant human C1 inhibitor) for Hereditary Angioedema 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 technologies in the field of tissue repair (via its collaboration with NovaThera) and DNA repair (via DNage BV). Additional information is available on the Pharming website, http://www.pharming.com and on http://www.dnage.nl.
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. The press release also appears in Dutch. In the event of any inconsistency, the English version will prevail over the Dutch version.
Contact:
Carina Hamaker, Investor Voice T: +31 (0)6 537 499 59 or T: +31 (0)71 52 47 400 Julia Philips (UK), Financial Dynamics, T: +44 (0)20 7269 7187 or T: +44 (0)7770 827 263 Samir Singh (US), Pharming Group NV, T: +1 908 720 6224 Rein Strijker, Pharming Group NV, T: +31 (0)71 52 47 400
