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Product Pipeline Descriptions
The information below provides some additional information about the products in CSL's product pipeline. This is a brief overview of the product. Information is organised according to its place in the pipeline.
Research/Pre-Clinical New Product DevelopmentNovel Plasma Products | Identification of novel therapeutic uses for plasma protein. | | Recombinant coagulation factors | Research activities to develop novel strategies for recombinant coagulation factors. | | rVIIa - FP | Recombinant coagulation factor VIIa with extended half-life. | | rIX - FP | Recombinant coagulation factor IX with extended half-life. | | Vaccines - Merck | ISCOMATRIX® Adjuvant vaccines - Merck: License and option agreement with Merck for a number of vaccine fields. | | Vaccines - Wyeth | ISCOMATRIX® Adjuvant Vaccines - Wyeth: License and option agreement with Wyeth for a number of vaccine fields. | | Vaccines - Solvay | ISCOMATRIX® Adjuvant Vaccines - License agreement with Solvay. | | CSL112 rHDL | Reconstituted high density lipoprotein (rHDL) for secondary treatment in acute coronary syndrome; rHDL is made from apoA1 lipoprotein isolated from human plasma then reconstituted with lipid. | | IL - I3R | Recombinant monoclonal antibody inhibiting interleukin-13 (IL-13) activity by targeting the IL-13 receptor for use in asthma. | | Discovery Projects | Research projects aiming to develop other recombinant proteins, particularly monoclonal antibodies. | | G-CSF | Recombinant Monoclonal Antibody against the cytokine granulocyte colony stimulating factor for the potential development of a new class of drugs that targets arthritis and other inflammatory diseases. | | CSL362 - AML | Recombinant Monoclonal Antibody against the IL-3 Receptor for the potential treatment of acute myeloid leukaemia. | P.Gingivalis/POD CRC-OHS/Sanofi | Vaccine to prevent and treat the severe gum disease Periodontitis, caused by the bacterium Porphyromonas gingivalis. |
Clinical Development Market Development
Hizentra® 20% SCIG EU | 20% subcutaneous immunoglobin for treatment of primary immune deficiency (PID); Recruitment of EU Phase III study complete. | | Zemaira® EU | Alpha1 - Proteinase Inhibitor in subjects with emphysema due to A1PI deficiency. | PCC New Indications | Prothrombin complex in Anti-Coagulant Reversal - Two Phase III trials running for demonstration of Beriplex in reversal of anti-coagulant therapy. | Fibrinogen Concentrate New Indications | Fibrinogen concentrate in subjects undergoing cardiac/aortic surgery. | | Biostate® EU | Plasma-derived Factor VIII / vWF product in clinical studies in subjects with Hemophilia A or von Willebrand's disease. |
New Product Development
CSL412 Improved Flu | Influenza ISCOMATRIX® vaccine; improved vaccine for the elderly. | | Vaccines - Merck | Merck has a license and option agreement to ISCOMATRIX® adjuvant in a number of vaccine fields. | | Partnered Vaccine Programs | A group of partnered vaccine projects using the ISCOMATRIX® adjuvant. | | CAM 3001 GM - CSFR MedImmune/AZ | Recombinant monoclonal antibody inhibiting GM-CSF activity by targeting the GM-CSF receptor for use in rheumatoid arthritis. Licensed to Astra Zeneca. Entered into a Phase II clinical trial in the first half of 2010. |
Registration/Post Launch
Life Cycle Management| Privigen® 10% IVIG | Liquid chromatographic 10% intravenous immunoglobulin for treatment of PID and ITP, registered in US, Canada and Europe, filed in Australia. | | Zemaira® US | Alpha1 - proteinase inhibitor in subjects with emphysema due to A1PI deficiency. | | Gardasil® | Vaccine providing protection against infection caused by Human Papillomavirus (HPV) Types 6, 11, 16 and 18. |
Market Development
| Berinert® | C1 Esterase Inhibitor in registration phase in US for subjects with congenital deficiency and acute abdominal and facial HAE attacks. Approved in Europe. | Riastap® Congenital Deficiency | Fibrinogen concentrate in Phase IV clinical studies in subjects with congenital fibrinogen deficiency. | Hizentra® 20% SCIG US | 20% subcutaneous immunoglobulin for treatment of primary immune deficiency (PID); approved in the US in March 2010. | | Influenza | Influenza vaccine (to protect against seasonal influenza disease) is registered and marketed globally. This includes the US and selected European countries. It is in the process of being registered in additional European countries. |
New Product Development
| H5N1 Pandemic Flu | H5N1 aluminium adjuvanted pandemic influenza vaccine registered as a prototype in Australia and Singapore and under evaluation in New Zealand. | | H1N1 Pandemic Flu | Novel Type A H1N1 Pandemic Influenza Vaccine registered in Australia and the US. |
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