CSL

Plasma product sales grew 34% to $3.79 billion
(17% in constant currency terms) when compared to the twelve months ended 30 June 2008. Strong contributions from immunoglobulins and critical care products have underpinned the growth.

Immunoglobulins grew 26% in constant currency terms with vigorous growth in Privigen®, consistent with the company’s transition program in favour of liquid over lyophilised presentations. Vivaglobin® (subcutaneous immunoglobulin), a product which provides the convenience of immunoglobulin self administration, attracted significant patient growth. Volume and price growth as well as the product mix all contributed to global growth in immunoglobulin sales. Specialty products Rhophylac® (Anti-D) and Tetagam® P (Tetanus) also boosted sales.

Recent approval of the first of two manufacturing facilities for Privigen® supports further expansion of this 10% liquid IVIg in the next year. The marketing application for our new proline stabilised 20% liquid subcutaneous immunoglobulin product is being reviewed by the US Federal Drugs Administration (FDA). We anticipate approval in mid 2010 so that we will be able to offer primary immune deficiency (PID) patients even more convenience.

The critical care segment grew 18% in constant currency terms underpinned by price and volume growth of albumin, particularly in the US and emerging markets. Specialty products, particularly Haemocomplettan® P, Beriplex® P/N and Berinert® P, also made a significant contribution. RiaSTAP™ (human fibrinogen) was approved by the FDA in January 2009 for the treatment of patients with a congenital deficiency of this coagulation protein.

Haemophilia sales grew 8% in constant currency, after adjusting for short-term supply issues with Monoclate-P®. Total sales volume grew by 11% with pricing steady, even though the total average price was affected by growth in lower priced emerging and tender markets.

In the US, immunoglobulins contributed significantly to the 20% growth in sales. European sales benefited from recent product launches including Beriplex® P/N (prothrombin complex) for rapid improvement of blood coagulation in patients receiving anticoagulant therapy, and Berinert® (C1 esterase inhibitor) for the treatment of edema caused by hereditary deficiency of this protein. Sales in Latin America, the Middle East and Canada were exceptionally strong.

Our research and development team is concentrating on expanding the registration of our products throughout the global marketplace, as well as new indications for existing products. One example is a pilot study assessing the benefit of fibrinogen in patients undergoing surgery who develop a deficiency of this protein which is essential to prevent bleeding. We continue to develop our recombinant coagulation protein candidates through the preclinical phase with the goal of commencing human trials with one prospect in 2011.

We are investing significant capital in our manufacturing base. This year we completed a second manufacturing facility in Bern for Privigen®. In Marburg, we are in the process of validating new aseptic filling and lyophilisation suites which will support future growth in coagulation and critical care products. These investments together with new albumin manufacturing facilities in Bern and Marburg will enable balanced manufacturing and sales volumes as we grow our business.

We also completed the renovation or relocation of 10 US plasma collection centres and a new state-of-the-art testing laboratory for plasma donations in Knoxville, Tennessee. CSL Plasma is well positioned to deliver plasma volumes that meet projected demand.