ABN 75 082 811 630 Human therapeutic products Human therapeutic products for for chronic respiratory and autoimmune diseases chronic respiratory and autoimmune diseases June 2004 June 2004
Summary Summary Product focused Product focused Listed on ASX: Nov 03 Listed on ASX: Nov 03 Attractive markets Attractive markets Cash at end FY04: $25m Cash at end FY04: $25m Effective management team Effective management team Grants receivable: $7.6m Grants receivable: $7.6m TGA approved facility TGA approved facility Shares outstanding: 108m Shares outstanding: 108m One Phase III product One Phase III product Two Phase II products Two Phase II products Capitalisation Capitalisation Two preclinical projects Two preclinical projects 60 $ millions 40 20 0 1999 2000 2001 2002 2003 2004
Product Pipeline Product Pipeline --------Clinical Trials---------- research preclinical phase I phase II phase III registration market Respiratory diseases Aridol TM – airway function Mid -2005 TM - cystic fibrosis Early -2008 Bronchitol TM - bronchiectasis Bronchitol Late -2007 TM - chronic bronchitis Bronchitol Late -2008 Autoimmune diseases PXS25 - multiple sclerosis PXS2030 – multiple sclerosis PXS2076 – rheumatoid arthritis 3-5 years 15 months 15 months 18 months 18 months 12 months indicative time to complete
Respiratory Disease Respiratory Disease Bronchitol TM TM Bronchitol Aridol TM TM Aridol TM in Phase II Bronchitol TM in Phase II Bronchitol New therapeutic New therapeutic � � Cystic fibrosis and COPD Cystic fibrosis and COPD TM in Phase III Aridol TM in Phase III Aridol Complete Phase II Q3 2004 Complete Phase II Q3 2004 First management tool for asthma First management tool for asthma Commence Phase III Q1 2005 Commence Phase III Q1 2005 � � and COPD and COPD Product Launch 2007 Product Launch 2007 Complete Phase III Q3 2004 Complete Phase III Q3 2004 � � Global Market Opportunity Global Market Opportunity � � Product launch Q3 2005 Aus/Europe Product launch Q3 2005 Aus/Europe � � CF: $1.1 billion+ CF: $1.1 billion+ Global Market Opportunity: Global Market Opportunity: � � COPD: $8 billion+ COPD: $8 billion+ $1.6 billion+ $1.6 billion+ Revenue Opportunity Revenue Opportunity � � Revenue Opportunity: Revenue Opportunity: � � CF: $340 million+ CF: $340 million+ $210 million+ $210 million+ COPD: $1.3 billion+ COPD: $1.3 billion+
Asthma Asthma 52 million people affected worldwide 52 million people affected worldwide 180,000 deaths worldwide (2003) 180,000 deaths worldwide (2003) Cost to US Healthcare – – US$15 billion per annum US$15 billion per annum Cost to US Healthcare TM Management Current Management Aridol TM Management Current Management Aridol Diagnosis by observation Diagnosis by observation Diagnosis by evidence Diagnosis by evidence Lung testing by specialists Objective measure of severity Lung testing by specialists Objective measure of severity Expensive Accurate Expensive Accurate Inconvenient Convenient Inconvenient Convenient Not specific for asthma Reveals lung inflammation Not specific for asthma Reveals lung inflammation Inaccurate 10- -20 minute test 20 minute test Inaccurate 10 Patients self manage Physicians monitor disease Patients self manage Physicians monitor disease Poor Outcomes Improved Outcomes Poor Outcomes Improved Outcomes
Chronic Obstructive Pulmonary Disease Chronic Obstructive Pulmonary Disease 30 million people affected worldwide 30 million people affected worldwide th leading cause of death 4 th leading cause of death 4 Cost to US healthcare - - US$40 billion pa US$40 billion pa Cost to US healthcare TM Management Current Management Aridol TM Management Current Management Aridol TM selects steroid responders Bronchodilators Aridol TM selects steroid responders Bronchodilators Aridol Patients trialed on steroids Reduces steroid exposure Patients trialed on steroids Reduces steroid exposure 1 in 5 respond to steroids Reduces healthcare costs 1 in 5 respond to steroids Reduces healthcare costs 4 in 5 palliative care Disease monitoring 4 in 5 palliative care Disease monitoring Dose optimisation optimisation Dose Poor Outcomes Improved outcomes Poor Outcomes Improved outcomes
TM opportunity by market segment Aridol TM opportunity by market segment Aridol Potential revenue $ Target patient population (000’s) Penetration % 440 3,660 3,052 mgmt-copd 16% 1,308 diag-copd 16% 5,966 asthma 9% mgmt-GP asthma diag- 11% GP asthma mgt- 29% spec Lung test- 75% spec 17,299 0 20 40 60 80 blue-asthma green - COPD $m Lung testing asthma-diag asthma mgmt-spec asthma mgmt-GP diag-copd mgmt-copd Total opportunity = $210m+
TM – Bronchitol TM – breaks the mucus cycle breaks the mucus cycle Bronchitol increased inflammation mucus production X impaired infection mucus clearance COPD / Cystic Fibrosis COPD / Cystic Fibrosis Three way action to accelerate Three way action to accelerate Target Profile Target Profile sputum clearance sputum clearance � Reduce exacerbations Reduce exacerbations Improves lung function Improves lung function � � Reduce Reduce hospitalisations hospitalisations Improves quality of life Improves quality of life � � Extend life expectancy Extend life expectancy Patient friendly Patient friendly � Complementary with other Complementary with other treatments treatments
Chronic bronchitis Chronic bronchitis without Bronchitol Bronchitol without TM TM
Chronic bronchitis Chronic bronchitis TM (400mg) with Bronchitol Bronchitol (400mg) with TM
TM Opportunity Bronchitol TM Opportunity Bronchitol Patient population (000’s) Revenue potential (millions) Patient population (000’s) Revenue potential (millions) 30000 $1,000 $890 27,000 20000 $500 $370 $340 10000 0.075 0.58 0 $0 CF BCS CB CF BCS CB ------COPD------ ------COPD------ Healthy uptake from cystic fibrosis patients (30%) Healthy uptake from cystic fibrosis patients (30%) Current treatments used by 33% patients Current treatments used by 33% patients � � Moderate uptake from bronchiectasis bronchiectasis patients (9%) patients (9%) Moderate uptake from Severe patients Severe patients � � Low uptake from chronic bronchitis patients (2%) Low uptake from chronic bronchitis patients (2%) Total revenue potential = $1.6 billion+ Total revenue potential = $1.6 billion+
Next Steps – – respiratory disease respiratory disease Next Steps Presentation of COPD Complete Commence CF Commence CF study at ERS COPD PII PIII study dosing study study Complete Commence CF comparator CF PII COPD PII COPD PIII study study study report study commence-UK 2004 2005 July Aug Sep Oct Nov Dec Jan Feb Mar mid-05 Aridol TM Complete Results from Submit Aridol TM study launch Aridol TM Aridol TM – Aus PIII study available registration – Aus/EU FDA GP asthma meeting management Aridol TM study commences-UK
Autoimmune Disease Autoimmune Disease PXS2030 PXS2030 PXS25 PXS25 Inhibitor of T cell migration Inhibitor of T cell migration Selective inhibitor of T cell Selective inhibitor of T cell � � � � Inhibitor of B cell proliferation Inhibitor of B cell proliferation migration migration � � Cannabinoid receptor agonist Cannabinoid receptor agonist Novel mechanism of action Novel mechanism of action � � � � Effective in MS and RA models Effective in MS and RA models Effective in MS and RA models Effective in MS and RA models � � � � Competitive Edge Competitive Edge Complementary with existing Complementary with existing � � Delivery by the oral route treatments Delivery by the oral route treatments � � Status Status Competitive Edge Competitive Edge Research Research Delivery by oral route Delivery by oral route � � � � Approach clinically validated Approach clinically validated PXS2076 PXS2076 � � Status Status Inhibitor of TNF Inhibitor of TNF � � Novel mechanism of action Novel mechanism of action Preclinical Preclinical � � � � Effective in RA models Effective in RA models Human studies Q2 2005 Human studies Q2 2005 � � � � Competitive Edge Competitive Edge Delivery by the oral route Delivery by the oral route � � Status Status Research Research Very large market opportunities � �
Finances Finances Financial Position Financial Position 6.1 1.5 Total - - $32.6m $32.6m Total 25 Cash at June 2004 CF Start Grant P3
Summary Summary st product launch 2005 1 st product launch 2005 1 Integrated business Integrated business Developing products for unmet clinical need Developing products for unmet clinical need Experienced management team Experienced management team TGA approved manufacturing facility TGA approved manufacturing facility Products from internationally respected groups Products from internationally respected groups Clinical validation for inhalation products Clinical validation for inhalation products
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