AUS BIO LTD “Better Medicines for Tomorrow” A “Snapshot of Activities” July 2010 1 Profile Discovery & Medicinal Chemistry Biotech company Commenced operations – mid 2002 Diverse R & D pipeline Current R & D focus MD 2009 Third Generation Anti Flu Therapeutics MD 920/921 – Phase IIb/III Wound Healing Clinical Study MD 922 – New Cosmetics/Formulations 2 Core Value Drivers Drug Candidates created Unmet Clinical Needs, Large Markets Bio Actives Identified Modified, Enhanced Drug Candidacy Improved Costs/Time Reduced Intellectual Property Owned Outright >40 Patents Issued/Applications No Third Party I.P. Negotiations Required 3 Overview R & D Pipeline MD 2001 Anti Infectives and Inflammatory Bowel Disease PC PC 2000 2000 Immune Hepatitis B&C Immune Modulators Modulators MD 920 Chronic Wound MD 920/921 Healing Advanced Wound (Chronic Venous Healing Products Ulcers) Aus Bio Proprietary Projects MD 2008 Development Development ofof Generic Drug Generic Drug Opportunities Opportunities MD MD 960/961/962 960/961/962 MD 922 MD 920/921 Cosmetics and Diabetic Skin Foot Health Ulcers Products MD MD 990 990 Specific Acute and Specific and Chronic Respiratory Chronic Respiratory Conditions Conditions MD 2009 MD 2009 Third Generation The Development of Anti Flu Next Generation Antiviral Compounds Therapeutics Diabetes Mellitus Diabetes Mellitus And And Insulin Resistance Resistance Insulin 4 Aus Bio R & D Programme “De-Risked” World Class Science/Scientists Experienced Board/Management “First in Class” Drug Development Programme Diverse R & D Pipeline Project MD 990 MD 960 MD 920/921 MD 922 PC 2000 MD 2001 MD 2009 Disease Target Respiratory e.g. Cough Diabetes/Insulin Resistance Advanced Wound Care Cosmetics & Skin Health Novel Immune Modulators Anti Infectives & IBD/IBS Third Generation Anti Influenza 5 MD 2009 – Influenza – Next Generation Anti Virals Background The emergence of Oseltamivir (Tamiflu®) resistant viruses has highlighted the need for the development of new anti viral drugs (CDC March, 2009) Drug Resistance - Oseltamivir (Tamiflu) - ≥ 95% resistance to Tamiflu reported to seasonal influenza H1N1 - Concerns Tamiflu resistant strains genetically combine with other flu strains, e.g. Influenza A (H1N1 – 09)/swine flu or H5N1 (avian) with greatly increased risk of lethal pandemic. Tamiflu resistance to swine flu (H1N1) now noted. Incidence Each year in the U.S. - 5% to 20% of population may get the flu - About 36,000 people die from post flu related causes and up to 500,000 die world wide 6 MD 2009 Influenza Anti Virals Clinical Need Seasonal Influenza - 5% to 10% world population infected - Increasing drug resistance - ‘Flu vaccines often inadequate Pandemic influenza threat - New ‘flu viruses - No/low population immunity - Governments stockpile - Tamiflu resistance appearing worldwide Influenza A (H1N1-09/swine flu) virus has resulted from triple recombination of human, avian and swine influenza viruses (NEJM , April 2009) 7 MD 2009 Influenza Anti Virals Capability Key scientific staff : Design & synthesis (with others) of the 1st and 2nd generation anti flu drug – neuraminidase inhibitors Patents granted over 1st and 2nd generation anti flu drugs – neuraminidase inhibitors Are uniquely placed to develop next generation anti virals Over past months conducted research, planning & design for “next generation” anti ‘flu drugs Wen-Yang Wu awarded National Clunies Ross National and Scientific Award for his contribution to Australian science (2000) e.g. design and synthesis zanamivir (Relenza). 8 MD 2009 Influenza Anti Virals Key Advantages Flu drug candidates: New Design, different mode of action. With resultant Improved therapeutic performance Improved Anti Viral Potency Reduced side effect profile Protects against flu strains not included in vaccine(s) Provides potential for efficacy against avian and swine influenza strains Provides alternative therapeutic for those in whom vaccination is contra indicated No existing antiviral has all of these characteristics 9 MD 920/921- Advanced Wound Healing Products MD 920 – Wound Healing Some Characteristics & Mode of Action Non Peptide, Stable in Wound Exudate Nitric Oxide Release, Endothelial Cells Stimulates Cell Growth and Mitotic Division Stimulates Smooth Muscle Dilatation Enhances Local Circulation, pain relief, no absorption Completion Phase Ib – no safety issues Phase IIb/III Protocol accepted; Patents Granted ++ 10 MD 922 – Cosmetics and Skin Health Products Stimulates recovery/regeneration skin cells Revitalizes aged fibroblast cells Reduces bacterial contamination Formulations for skin health/care, cosmetic creams Patent protection Faster route to market (non therapeutic) 11 PC 2000, Immune Modulators Immune Modulators Diverse Actions Targets eg NIH Support Modify/Enhance Immune System Response Increase Anti Tumor & Anti Infective Cytokines, Killer Cells Increase “T” cell (memory) Differentiation Many/Varied a) Infections eg. Viral, Bacterial b) Malignancies Market Size . Large Interferons α, β, γ ≥ US 5 Billion/year BUT Side Effects +++ Decreased patient acceptance Need Immune Modulators without side effects for future Standard of Care 12 PC 2000, Immune Modulators Progress to Date Compound Synthesis and Selection “In House” Ongoing US, NIAID (NIH) Promising Initial Results Hepatitis C Model Human Cell Line, Single Dose PC 2123 Similar Activity (Anti HCV) to Interferon α, but Reduced Cytotoxicity Support NIH Testing Programme 13 MD 990, Respiratory Conditions Mode of Action NOT IS Enhances/Influences Normal Biological Repair Pathways Aids Post Infection Recovery Reduces Post Infection Cough Immunosuppressant or TNF sequestrant β Agonist, Cytokine or Monoclonal Antibody Injury Repair Agent with PoC In Vitro Model Efficacy Trend Guinea Pig Model Ongoing Satisfactory Safety and Tolerance Studies Patent Protection Sought 14 MD 960, Diabetes Primary Objective To Develop a Drug that is – First in Class, Orally Active, Few Side Effects Synergies with Existing Therapies Reduced Hyperglycaemia and Insulin Resistance Additional non Hypoglycaemic Benefits Commercially Attractive e.g. no negative CVS effects (FDA) 15 MD 960, Diabetes Results to Date Hyperglycaemia Normalised 2 Rat Models Mode of Action Insulin Sensitizer – Non PPAR Inhibition of PTP’ase Induction of Nitric Oxide Additional Characteristics Positive Vascular Effects., Important to FDA Orally Bioavailable, Good Safety Profile Additional PoC Cost ~$200k Patents granted, U.S., China, Europe etc. 16 Aus Bio’s MD 2001 Project Gilax “a safe and effective gut cleanser” Some features: Improves gut immunity Neutralises gut toxins Gut anti inflammatory and anti diarrhoea agent Compatability with probiotics No bacterial resistance problems No systemic side effects (low oral bioavailability) 17