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Octapharma AG (Switzerland) was the sole partner during these two decades. The current contract, representing the 7th in a row, is valid until the end of June 2009, and a new national tender for the years to come is expected to be issued by mid-2008. Octapharma A.S (Norway) has administered the project from the day of funding (1st of November 1988), in close cooperation with the Red Cross & National Hospital Blood Center and key clinical institutions such as the National/University Hospital and National Institute for Haemophilia in Oslo. The first plasma from Norway was shipped in April 1988, and until the end of March 2008 Octapharma received and fractionated 1,017,000 litres of plasma from 217 plasma shipments into 975 batches of various plasma-derivatives. Today most of the plasma-derivatives are manufactured by Octapharma AB (Sweden), with support from Octapharma Pharmazeutika Produktionsges.m.b.H (Austria) for some special products. The introduction of new products from the Octapharma portfolio started with albumin and coagulation factors in 1988. The other plasma-derivatives followed the scientific and market developments both at Octapharma and in Norway. Market access was assured for all products based on the national plasma in close collaboration with the Norwegian Medicines Agency, and altogether 17.6 tons of albumin, 220 million IU of coagulation factors (FVIII, FIX, VWF, and prothrombin complex concentrates), 1.1 ton of immunoglobulins [introduced 1994 (IVIG) and 2005 (SCIG)], and 516,000 bags of virus inactivated plasma for infusion (octaplas® ; introduced 1993) have been used by the numerous hospitals and other health institutions during the 20 years. Based on standard dosing of these plasma-derivatives, the amount of finished goods returned by Octapharma is equivalent to more than 1 million treatment episodes (51,000/year and 140/day). Almost 500 patients suffering from chronic coagulation and immune deficiencies have been treated solely with Octapharma products for the last two decades. Drug-related adverse events have been registered in only 1 per 72,000 treatment episodes, which is important in Norway due a decentralized organisation of patient treatment, including extended home therapy of haemophiliacs in a geographically -scattered area. Since the foundation of Octapharma as a company 25 years ago, research & development of new plasma-derivatives based on own, novel technology and manufactured in state-of-the-art GMP-licensed manufacturing facilities has been the company’s main focus. Through important scientific input and conduct of both biochemical studies [4] and human trials, Norway has contributed to Octapharma’s success, especially for products such as octagam® [5-10], octaplas® [11,12] and uniplas® [13-16]. The early introduction of octaplas® after the first clinical study completion helped Norwegian hospitals to reduce the number and severity of adverse events – and by that costs – in intensive care [17]. All patients admitted to Norwegian hospitals and in need of plasma-derivatives have been treated with virus inactivated products based on plasma of local origin for the past 20 years. This mainstay in national blood therapy was made possible through a well-defined self-sufficiency project, which would not have been possible without the dedicated and professional contribution from the Norwegian blood centers [18], the guidance and support by the national health authorities, and motivation and loyalty shown by key health care personnel and patient organizations [19]. It is our belief that Octapharma, through its active research & development, state-of-the-art product portfolio at any time, high yield and security in production, and commitment to the principle of self-sufficiency has contributed to not only the medical, but also the economic success of Norway’s plasma fractionation project through an optimal utilisation of the local, precious plasma raw material [20]. There is no doubt that the Norwegian Self-Sufficiency Project has been important for Octapharma’s development since it has served as a model for other countries that decided to follow the same path. We are proud of having been a part of this project and express our gratitude to all our partners and customers in Norway – with the best wishes for an equally successful future. Wolfgang Marguerre Chief Executive Officer Octapharma Group John Erik Ørn References: [1] Evensen SA, et al. HIV infection in Norwegian haemophiliacs: the prevalence of antibodies against HIV in haemophiliacs treated with lyophilised cryoprecipitate from volunteer donors. Eur J Haematol 1987; 39:44-48 [2] Solheim BG, et al. Self-sufficiency for plasma and plasma proteins in Norway. Beitr Infusionsther Transfusionsmed 1996; 33:98-102 [3] Solheim BG, et al. Self-sufficiency for blood and plasma products in Norway. Biol Clin Hematol 1992; 14:103-105 [4] Olsen H, et al. Pharmaceutical-grade albumin: impaired drug-binding capacity in vitro. BMC Clinical Pharmacology 2004; 4:4 [5] Aukrust P, et al. Release of cytokines, soluble cytokine receptors, and interleukin-1 receptor antagonist after intravenous immunoglobulin administration in vivo. Blood 1994; 7:2136-2143 [6] Aukrust P, et al. Modulation of lymphocyte and monocyte activity after intravenous immunoglobulin administration in vivo. Clin Exp Immunol 1997; 107:50-56 [7] Aukrust P, et al. Effects of intravenous immunoglobulin in vivo on abnormally increased tumour necrosis factor-a activity in human immunodeficiency virus type 1 infection. J Infect Dis 1997; 176:913-923 [8] Aukrust P, et al. Administration of intravenous immunoglobulin (IVIG) in vivo – down-regulatory effects on the IL-1 system. Clin Exp Immunol 1999; 155:136-143 [9] Gullestad L, et al. Immunomodulating therapy with intravenous immunoglobulin in patients with chronic heart failure. Circulation 2001; 103:220-225 [10] Aukrust P, et al. Complement activation in patients with congestive heart failure. Circulation 2001; 104:1494-1500 [11] Solheim BG, et al. The use of Octaplas in patients undergoing open-heart surgery. In Müller-Berghaus G, et al. DIC: pathogenesis, diagnosis and therapy of disseminated intravascular fibrin formation 1993; 253-262 [12] Solheim BG, et al. Viral safety of solvent/detergent-treated plasma. Transfusion 2000; 40:84-90 [13] Noddeland H, et al. Universal solvent/detergent-treated fresh frozen plasma (uniplas®) – rationale and clinical properties. Thromb Res 2002; 107:S33-S37 [14] Tølløfsrud S, et al. Universal fresh frozen plasma (uniplas®): a safe product in open-heart surgery. Intensive Care Med 2003; 29:1736-1734 [15] Solheim BG, et al. Universal fresh-frozen plasma (uniplas®): an exploratory study in adult patients undergoing elective liver resection. Vox Sang 2005; 89:19-26 [16] Solheim BG. Universal pathogen-reduced plasma in elective open-heart surgery and liver resection. Clinical Medicine & Research 2006; 4:209-217 [17] Flesland O. A comparison of complication rates based on published haemovigilance data. Intensive Care Med 2007; 33:S17-S21 [18] Heier HE. Production and consumption of blood and blood products in Norway. Tidsskr Nor Lægeforen 1993; 113:18-22 [19] Glomstein A. Self-sufficiency and blood transmitted diseases. Blood Coagulation and Fibrinolysis 1995; 6:S23-S26 [20] Flesland O, et al. The Norwegian plasma fractionation project – a 12 year clinical and economic success story. Transfusion and Apheresis Science 2003; 28:93-100 |
