Recent Highlights
CSL has experienced unprecedented growth over the past few years. We continue to expand our research and development of plasma replacement therapies, immunomodulators (using our ISCOMATRIX® adjuvant) and therapeutic proteins.
Replacement Therapies
A major R&D emphasis in the last 12 months has been improved immunoglobulin products, with registration of the state-of-the-art liquid product Privigen®, a new chromatographic intravenous immunoglobulin (IVIg), in the US and Europe. 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). Research progressing our recombinant coagulation program has resulted in pre-clinical proof of principle data showing extended half life for recombinant FVIIa and FIX albumin fusion proteins.
Vaccines
GARDASIL®
A key R&D event for 2006 was licensing of the Merck and Co. human papillomavirus vaccine, GARDASIL
®, in the US, Europe and Australia. This vaccine provides protection against infection 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 received approval from the FDA to market Afluria
®, an influenza vaccine, in the United States. Afluria
® was released for sale in the US October 2007. CSL also continues to expand its influenza vaccine registration in European countries, with registration recently achieved in Germany and Ireland.
In June 2008, following completion of successful clinical studies, CSL received approval from the Australian Therapeutic Goods Administration (TGA) for Panvax
®, CSL's pandemic influenza vaccine. The vaccine has been registered for use only after the declaration of a Pandemic by the Chief Medical Officer of Australia.
ISCOMATRIX® Adjuvant
In December 2007, Merck & Co continued to show confidence in the ISCOMATRIX
® adjuvant by adding two additional fields 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 ISCOMATRIX
® adjuvant at a commercial scale.
CSL has also completed the first stages of establishing large-scale manufacturing of ISCOMATRIX
® adjuvant at its Kankakee, Illinois site.
Therapeutic Proteins
In the Therapeutic Proteins program we have progressed clinical development of the CSL360 antibody for acute myeloid leukemia and the CAM3001 GM-CSFR product (partnered with AstraZeneca/MedImmune) entered the clinic. We also entered into a strategic alliance with Celltrion for the manufacturing of recombinant proteins.
We also have a portfolio of earlier stage projects including a project to develop therapeutic antibodies that inhibit the activity of the cytokine granulocyte colony stimulating factor (G-CSF) for the potential development of a new class of drugs that target arthritis and other inflammatory diseases.