We continue to invest in new protein-based product development projects for treating serious human diseases. These medicines are derived from our core technologies in plasma fractionation, vaccinology, recombinant proteins (including recombinant antibodies) and our immunostimulating ISCOMATRIX® adjuvant.

We have successfully integrated all global research and development activities. In the Northern Hemisphere, we have centres of excellence to support plasma product manufacturing in Marburg, Germany (coagulation and specialty products), Bern, Switzerland (immunoglobulins) and Kankakee, USA (Alpha-1-PI). In Melbourne, we support our Australian plasma and influenza vaccine products, and conduct our new product development activities.

Merck & Co. Inc., the exclusive licensee of our human papillomavirus (HPV) vaccine, is now well advanced in its Phase III clinical development program and has announced that filing with the US FDA for a product license will take place in the second half of 2005. Publications of clinical data from Merck during the year continue to give us confidence that this vaccine will make a strong contribution to international public health by preventing certain types of cervical cancer and genital warts. 

Developing new high value products from human plasma remains a key strategic imperative. In Canada, we have now begun a Phase II clinical trial of our plasma-derived reconstituted high-density lipoprotein (rHDL) drug. The trial will test whether infusions of rHDL can reduce the volume of atherosclerotic plaque in the coronary arteries of patients with acute coronary syndromes. The clinical development program for ZLB Behring’s chromatographically purified liquid IVIG product has also begun. 

Over the past few years, we have invested significantly in our proprietary ISCOMATRIX® adjuvant technology. When formulated with an antigen, an adjuvant will increase the quality and strength of the immune response to the antigen. We believe that the ISCOMATRIX® adjuvant has unique properties that will enable it to be part of a new range of potential immunotherapeutic products and vaccines. Our commercialisation strategy is to broadly license the ISCOMATRIX® adjuvant technology to partners who have an interest in enhancing the immune response of their own product candidates. The recently announced agreement with Merck & Co. Inc. is further validation of this strategy. However, we also continued the development of our own biotech product for the treatment of HPV infection that combines the adjuvant technology with a patented E6/E7 fusion protein from the main cancer-causing serotype HPV16. This product has been tested for safety and immunogenicity in both HIV negative and positive individuals, and we are planning a Phase II clinical study to test whether we can treat precancerous lesions in anal intra-epithelial neoplasia (AIN). 

As the only manufacturer of influenza vaccine in the Southern Hemisphere, we are very conscious of the threat posed by the annual influenza season and particularly in an influenza pandemic. CSL is working closely with health authorities in Australia to ensure that we can respond as rapidly as possible in the event that a pandemic is declared. We have made a manufacturing seed from the H5N1 strain, a potential pandemic strain circulating in bird populations in South-East Asia, and will conduct our first clinical trials of this prototype vaccine in the second half of 2005. 

Consistent with our focus on protein-based medicines, we are developing a number of earlier stage recombinant antibody opportunities with Australian academic partners. These include new ways to potentially treat myeloid leukemia (Institute of Medical and Veterinary Sciences in Adelaide) and a technology to achieve topical delivery of antibody fragments for treating serious eye diseases (Flinders University also in Adelaide).

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