CSL has experienced unprecedented growth over the past few years. We continue to expand our research and development of plasma therapeutics, vaccines, our ISCOMATRIX^® adjuvant and recombinant proteins.

Plasma Therapeutics
In July 2007, the FDA approved Privigen™, a new chromatographic intravenous immunoglobulin (IVIg). Applications for regulatory approval have also been filed with the European Medicines Agency (EMEA), Health Canada, Swissmedic, and the Australian Therapeutic Goods Administration (TGA). Privigen™ , is a high-yield, proline-stabilised IVIg that is ready for immediate use, requiring no refrigeration or reconstitution. The product is indicated for treatment of patients diagnosed with primary immunodeficiency (PI) and chronic immune thrombocytopenic purpura (ITP).

In April 2007, Rhophylac^®, an intravenous anti-D Rh immunoglobulin (Ig) or Rho(D), was approved by the United States Food and Drug Administration (FDA) for an additional indication. Rhophylac^® is indicated to raise platelet counts in Rh(D)-positive, non-splenectomised adult patients with chronic ITP.

In January 2006, Vivaglobin^® became the first subcutaneous liquid immunoglobulin product approved by the United States Food and Drug Administration (FDA). Vivaglobin^® allows patients with primary immune deficiency greater convenience by allowing them to self-administer their therapy. Phase III clinical trials have started on a new high-yielding chromatographic version of Vivaglobin^®.

Vivaglobin® subcutaneous immunoglobulin became the first product of its kind to be launched in the US market.

In January 2006, Vivaglobin^® became the first subcutaneous liquid immunoglobulin product approved by the United States Food and Drug Administration (FDA). Vivaglobin^® allows patients with primary immune deficiency to self-administer their therapy. Phase III clinical trials have started on a new high-yielding chromatographic version of Vivaglobin^®.

Vaccines

GARDASIL^{^®:}

A key R&D event for 2006 has been licensing of the Merck and Co. human papillomavirus vaccine, GARDASIL^®, in the US, Europe and Australia. This vaccine provides protection against infection caused by Human Papillomavirus (HPV) Types 6, 11, 16, and 18. The vaccine is based on technology licensed by CSL to Merck & Co.in 1995 which was developed as a result of a collaboration in the early 1990s between CSL and Professor Ian Frazer of the University of Queensland. CSL has exclusive marketing rights for GARDASIL^® in Australia and New Zealand.

Influenza Vaccines: Following the completion of successful clinical trials, CSL has received approval from the FDA to market Afluria^®, an influenza vaccine, in the United States. Afluria^® was released for sale in October 2007. In 2007, CSL registered its influenza vaccine in several European countries.

Following a number of clinical studies, a Core Pandemic Dossier was submitted to the Australian Therapeutic Goods Administration (TGA) to support registration of a prototype pandemic influenza vaccine.

ISCOMATRIX^{^®} Adjuvant
In December 2007, Merck & Co. continued to show confidence in the ISCOMATRIX^® adjuvant by adding two additional licenses to the already substantial agreement.

In 2007 the transfer of the manufacturing process from Parkville to Kankakee was complete. Kankakee is now performing routine GMP manufacture of the ISCOMATRIX^® adjuvant on a commercial scale.

CSL has also completed the first stages of establishing large-scale manufacturing of ISCOMATRIX^® adjuvant at its Kankakee, Illinois site.

Recombinant Proteins
CSL’s acquisition of Zenyth Therapeutics, a biotechnology company focused on the development and commercialisation of therapeutic antibodies for inflammation and cancer, was completed in November 2006. This acquisition increased our portfolio of product candidates.

Two monoclonal antibody programs entered clinical studies in 2007:

CSL360 to treat acute myeloid leukaemia
CAM3001 to treat rheumatoid arthritis
MK6105 to treat asthma