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ABN 75 082 811 630 Committed to the research, development and Committed to the research, development and commercialisation of human therapeutic products for commercialisation of human therapeutic products for chronic respiratory and autoimmune


  1. ABN 75 082 811 630 Committed to the research, development and Committed to the research, development and commercialisation of human therapeutic products for commercialisation of human therapeutic products for chronic respiratory and autoimmune diseases chronic respiratory and autoimmune diseases January 2004 January 2004

  2. Overview Overview Our Objective Our Objective � to build a valuable business, recognised internationally for its to build a valuable business, recognised internationally for its � approach to therapeutic discovery, development and approach to therapeutic discovery, development and commercialisation in the fields of respiratory and autoimmune commercialisation in the fields of respiratory and autoimmune diseases diseases Our Strategy Our Strategy � attractive product opportunities attractive product opportunities � � engage in the complete product value chain engage in the complete product value chain � � focus on products focus on products � � focus on core therapeutic markets focus on core therapeutic markets � � maintain and build a diversified product pipeline maintain and build a diversified product pipeline �

  3. Company History Company History 1999 GBS Venture Partners invests $2M to develop GBS Venture Partners invests $2M to develop 1999 autoimmune disease research (ANU) autoimmune disease research (ANU) 2001 Licence from Royal Prince Alfred Hospital for Licence from Royal Prince Alfred Hospital for 2001 treatment of respiratory disease treatment of respiratory disease 2002 Second round funding of $9.6 Second round funding of $9.6 – – GBS Venture GBS Venture 2002 Partners, CM Capital, CIBC Australia, ANU and Partners, CM Capital, CIBC Australia, ANU and Mooroolbark Technology Mooroolbark Technology 2002 Consolidation of operations at Frenchs Frenchs Forest Forest 2002 Consolidation of operations at 2003 $3 million grant to develop cystic fibrosis treatment 2003 $3 million grant to develop cystic fibrosis treatment ≈ $5 million secured R&D grants totalling ≈ - secured R&D grants totalling $5 million - 2003 $25 million raised at IPO 2003 $25 million raised at IPO

  4. TGA approved facilities TGA approved facilities Frenchs Forest NSW Forest NSW Frenchs

  5. Products Products Name Category Indication Aridol lung function test asthma/COPD Aridol lung function test asthma/COPD TM TM Bronchitol therapeutic chronic bronchitis Bronchitol therapeutic chronic bronchitis TM TM bronchiectasis bronchiectasis cystic fibrosis cystic fibrosis PXS25 therapeutic multiple sclerosis PXS25 therapeutic multiple sclerosis rheumatoid arthritis rheumatoid arthritis PXS2000 therapeutic rheumatoid arthritis PXS2000 therapeutic rheumatoid arthritis other other

  6. Diversified Product Portfolio Diversified Product Portfolio ---------------Clinical Trials----------------- research preclinical phase I phase II phase III registration Respiratory diseases TM - cystic fibrosis in Bronchitol progress TM - bronchiectasis in Bronchitol progress TM - chronic bronchitis Bronchitol TM – airway function in Aridol progress Autoimmune diseases in PXS25 - multiple sclerosis progress PXS25 - rheumatoid arthritis in PXS2000 – multiple sclerosis progress 3-5 years 15 months 15 months 18 months 18 months 12 months indicative time to complete

  7. Clinical Trials in Progress Clinical Trials in Progress TM (Phase III) Aridol Mid 2004 CTM Nov 03 Jun 04 approvals dosing/recruitment (600 patients) manufacture Report 100 TM for cystic fibrosis (Phase IIa) Bronchitol Mid 2004 CTM Nov 03 Jun 04 approvals dosing/recruitment (60 patients) manufacture Report 1 Bronchitol for bronchiectasis (Phase IIa) CTM Mid 2004 Sep 03 May 04 approvals dosing/recruitment (60 patients) manufacture Report 20

  8. Respiratory diseases Respiratory diseases (Chronic obstructive lung diseases) (Chronic obstructive lung diseases) Lung defence (normal) Lung defence (normal) Mucus Mucus Airway Surface Airway Surface Cilia Cilia Liquid Liquid Ciliated Cell Goblet Cell Submucosal glands Submucosal glands

  9. Respiratory diseases Respiratory diseases (Chronic obstructive lung diseases) (Chronic obstructive lung diseases) Lung defence (compromised) Lung defence (compromised) Mucus Mucus Airway Surface Airway Surface Cilia Cilia Liquid (thin/viscous) Liquid (thin/viscous) Ciliated Cell Goblet Cell Submucosal glands Submucosal glands

  10. Respiratory diseases Respiratory diseases (Chronic obstructive lung diseases) (Chronic obstructive lung diseases) Lung defence (after Bronchitol Bronchitol) ) Lung defence (after Mucus Mucus Airway Surface Airway Surface Cilia Cilia Liquid Liquid Ciliated Cell Goblet Cell H 2 O H 2 O H 2 O H 2 O H 2 O Submucosal glands Submucosal glands

  11. Study in Patients with Bronchiectasis Bronchiectasis Study in Patients with Right Peripheral Region of Lung 40 Mean % Clearance 30 20 10 0 120min 24hr -10 p<0.001 p<0.003 without Bronchitol [n=8] with Bronchitol [n=8]

  12. Chronic bronchitis Chronic bronchitis without Bronchitol Bronchitol without TM TM

  13. Chronic bronchitis Chronic bronchitis TM (400mg) with Bronchitol Bronchitol (400mg) with TM

  14. Trial Participants Trial Participants “It has been some weeks since my part of the trial It has been some weeks since my part of the trial “ finished and to be honest I have not felt as well as when finished and to be honest I have not felt as well as when I was on the Bronchitol Bronchitol. .” ” I was on the Trial participant 1 Trial participant 1 “Thank you for any help that you can give and I wish you “ Thank you for any help that you can give and I wish you well with the Bronchitol Bronchitol project as it has made such a project as it has made such a well with the difference to my health.” ” difference to my health. Trial participant 2 Trial participant 2 “This patient has been on the Phase II clinical trial of This patient has been on the Phase II clinical trial of “ Bronchitol for for bronchiectasis bronchiectasis. This has . This has revolutionised revolutionised her her Bronchitol life, she would benefit and would be greatly relieved of life, she would benefit and would be greatly relieved of her daily symptoms if she could continue this treatment.” ” her daily symptoms if she could continue this treatment. Physician Physician

  15. Bronchitol Bronchitol TM TM for Chronic Obstructive Lung Diseases for Chronic Obstructive Lung Diseases

  16. TM Aridol TM Aridol Dose required to cause 15% fall in lung function 600 500 400 300 Aridol 200 100 0 Severe Moderate Mild Normal Asthma severity Current With Aridol monitoring Steroid use

  17. Aridol TM Aridol TM for asthma management for asthma management

  18. PXS S25 25 PX Treatment of autoimmune disease Treatment of autoimmune disease � multiple sclerosis multiple sclerosis � � rheumatoid arthritis rheumatoid arthritis � Selective inhibitor of T cell migration Selective inhibitor of T cell migration Effective in models of multiple sclerosis and rheumatoid Effective in models of multiple sclerosis and rheumatoid arthritis arthritis Early preclinical safety testing Early preclinical safety testing

  19. PXS2000 0 PXS200 Treatment of autoimmune disease Treatment of autoimmune disease multiple sclerosis multiple sclerosis � � rheumatoid arthritis rheumatoid arthritis � � Selective activator of peripheral cannabinoid cannabinoid receptors receptors Selective activator of peripheral Effective in models of multiple sclerosis Effective in models of multiple sclerosis Late stage research Late stage research

  20. Senior Management Senior Management Internationally experienced and capable team with track record Alan Robertson BSc Alan Robertson BSc, PhD , PhD Chief Executive Chief Executive Wellcome/Faulding/amrad Wellcome/Faulding/amrad Brett Charlton MBBS, PhD Medical Director Baxter/Stanford/ANU Brett Charlton MBBS, PhD Medical Director Baxter/Stanford/ANU William Cowden BSc BSc, PhD , PhD Chief Scientist Progen/Peptech/ANU William Cowden Chief Scientist Progen/Peptech/ANU David McGarvey BA, CA David McGarvey BA, CA Finance Finance PWC/Memtech PWC/ Memtech/US Filter /US Filter John Crapper BAS, MBA John Crapper BAS, MBA Operations Operations Syntex/Memtech/US Filter Syntex/Memtech/US Filter Gary Phillips BPharm BPharm, MBA , MBA Commercial Novartis Gary Phillips Commercial Novartis Staff 24 Staff 24

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