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AUS BIO LTD “ Better Medicines for Tomorrow ” A “Snapshot of Activities” July 2010. 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
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AUS BIO LTD“Better Medicines for Tomorrow”A “Snapshot of Activities”July 2010
ProfileDiscovery & 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
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
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 Disease Target • MD 990 Respiratory e.g. Cough • MD 960 Diabetes/Insulin Resistance • MD 920/921 Advanced Wound Care • MD 922 Cosmetics & Skin Health • PC 2000 Novel Immune Modulators • MD 2001 Anti Infectives & IBD/IBS • MD 2009 Third Generation Anti Influenza
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
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)
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).
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
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 ++
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)
PC 2000, Immune Modulators • Immune Modulators NIH Support Diverse Actions • Modify/Enhance Immune System Response • Increase Anti Tumor & Anti Infective Cytokines, Killer Cells • Increase “T” cell (memory) Differentiation Targets • 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 eg .
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
MD 990, Respiratory Conditions • Mode of Action • Enhances/Influences Normal Biological Repair Pathways • Aids Post Infection Recovery • Reduces Post Infection Cough NOT • Immunosuppressant or TNF sequestrant • β Agonist, Cytokine or Monoclonal Antibody IS • Injury Repair Agent with PoC In Vitro Model • Efficacy Trend Guinea Pig Model • Ongoing • Satisfactory Safety and Tolerance Studies • Patent Protection Sought
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)
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 • Positive Vascular Effects., Important to FDA • Additional Characteristics • Orally Bioavailable, Good Safety Profile • Additional PoC Cost ~$200k • Patents granted, U.S., China, Europe etc.
Aus Bio’s MD 2001 ProjectGilax“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)