CSL

CSL invests in the development of protein-based medicines to treat serious human illnesses. Most of our licensed medicines are purified from human plasma or made from traditional sources, like our influenza vaccines. CSL is also increasing investment in the capabilities required to develop future products using recombinant DNA technology.

Global research and development activities support CSL’s core businesses and three other main areas of new product development:

• Replacement therapies that build on our plasma products portfolio;
• Therapeutic proteins based on recombinant proteins and antibodies; and
• Vaccines that use our proprietary ISCOMATRIX® adjuvant and/or our influenza vaccine capabilities.

Our replacement therapies focus has been on supporting the registration of Privigen^TM in the US and Europe, further clinical development of our 20% subcutaneous immunoglobulin, progressing our recombinant coagulation projects, and expanding the indications for existing plasma products. Our therapeutic proteins program delivered further progress with early stage clinical development of a recombinant antibody for acute myeloid leukemia and our GM-CSF antibody licensed to AstraZeneca and Medimmune, Inc.

The CSL research team located in the Molecular Science and Biotechnology Institute at Melbourne University (Bio21) manages a significant portfolio of early stage biotechnology research projects. During the past year, we have strengthened our clinical, regulatory and product development capabilities associated with this portfolio.

In September 2007, CSL achieved a major milestone when the FDA approved our seasonal influenza vaccine Afluria® for sale in the US. For the next two to three years, significant clinical and regulatory commitments will continue with further clinical trials in adults, the elderly and the very young. In June 2008, the Therapeutic Goods Administration approved our Panvax® prototype pandemic avian influenza vaccine for registration in Australia.

An adjuvant enhances the immune response when formulated with a vaccine antigen. We continue to make good progress with our ISCOMATRIX® adjuvant and have several commercial partners with vaccine candidates at various stages of clinical development. To facilitate supply of ISCOMATRIX® to our international commercial partners for clinical trials, commercial scale production is now being carried out in the US at our Kankakee site.

To enhance our ability to commercialise current projects, we are working to increase capacity to carry out later stage product development, particularly in strategic clinical trial design and the development of new products from recombinant proteins.

We will continue to seek out high quality new product opportunities that enable us to apply the competitive strengths of our core research and development capabilities to contribute to CSL’s future growth.