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CSL Behring Report
Strong demand for CSL Behring products once again demonstrated the life enhancement they bring to people with congenital or acquired deficiencies in plasma proteins. Total sales of $2.8 billion increased 7% over the previous year or 15% after adjusting for adverse foreign currency movements. The business continued to leverage infrastructure and operating efficiencies to achieve a 9% increase in earnings before interest and tax over last year.
US sales were encouraging with high double digit growth but the stand out performance was sales in Latin America, the Middle East and Canada which contributed to the strongest year on year growth. A highlight was the securing of significant contracts for supply to Canada for a broad range of products, the full benefits of which will be realized in future years. European sales remained robust with continuing growth opportunities in immunoglobulins and critical care products.
PrivigenTM was launched in the United States in February 2008 and favourably received by the market. PrivigenTM is a 10% immunoglobulin, proline stabilised preparation that offers room temperature storage for up to two years. Combined immunoglobulin sales grew strongly with healthy demand for all presentations. Sales of Vivaglobin® , a subcutaneous immunoglobulin, were particularly strong in the US.
We continue to have success with plasma-derived Factor VIII/vWF products with our market leading Humate® P for the treatment of von Willebrand disease. Helixate® recombinant Factor VIII sales have continued to grow year on year due in part to successful tendering in the UK market.
Our prothrombin complex, Beriplex ® P/N was launched in several European countries following its broad European approval in January this year. Beriplex® P/N rapidly improves blood coagulation in patients who bleed when receiving warfarin anticoagulant therapy.
Increased demand for albumin in China, South America and the Middle East contributed to significant growth enabling balanced manufacturing and sales volumes. Critical care products Haemocomplettan ® (fibrinogen) and Berinert® P (C1 esterase inhibitor) made solid gains in sales in Central European markets.
Our portfolio of specific immunoglobulins continues to grow at double digit rates led by Rhophylac® and Cytogam®. Rhophylac ® is indicated for preventing haemolytic disease in the newborn (HDN) and achieved US marketing authorisation for treatment of idiopathic thrombocytopenic purpura, an auto-immune disease that causes bleeding as a result of low blood platelet counts. Our first full year of Cytogam® confirmed the potential of this product in the prevention of cytomegalovirus infection in solid organ transplants.
Plasma collections by ZLB Plasma grew in line with demand to meet growth in patient needs, particularly for immunoglobulin. ZLB Plasma has become one of the most efficient plasma collection operations globally.
The productivity of our research and development team was most rewarding with the approval of PrivigenTM in the US, Europe, Canada and Switzerland, and the European approval of Beriplex® P/N for anticoagulant reversal in bleeding patients. Good progress was made in clinical trials of our second generation subcutaneous immunoglobulin for primary immune disease (PID) and fibrinogen for congenital deficiency. We have also made progress in preclinical development of a recombinant coagulation factor, Factor VIIa FP. This protein has an extended half life (clinical activity) in animal models and, if human trials are successful, patients will need fewer infusions.
Our manufacturing centres of excellence continue to drive efficiencies, extract more products per litre of plasma and process increased volumes and we are increasing our capital investments to meet growth expectations.
PrivigenTM is a 10% immunoglobulin, proline stabilised preparation that offers room temperature storage for up to two years, increasing patient convenience. Launched in the US in February 2008, PrivigenTM has been favourably received.