Transcript AUS BIO LTD

AUS BIO LTD
“Better Medicines for Tomorrow”
A “Snapshot of Activities”
July 2010
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Profile
Discovery & Medicinal Chemistry Biotech company
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Commenced operations – mid 2002
Diverse R & D pipeline
Current R & D focus
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MD 2009 Third Generation Anti Flu Therapeutics
MD 920/921 – Phase IIb/III Wound Healing Clinical
Study
MD 922 – New Cosmetics/Formulations
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Core Value Drivers
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Drug Candidates created
Unmet Clinical Needs, Large Markets
 Bio Actives Identified
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Modified, Enhanced
Drug Candidacy Improved
Costs/Time Reduced
Intellectual Property
Owned Outright
 >40 Patents Issued/Applications
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No Third Party I.P. Negotiations Required
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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
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Aus Bio R & D Programme “De-Risked”
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World Class Science/Scientists
Experienced Board/Management
“First in Class” Drug Development Programme
Diverse R & D Pipeline
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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
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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)
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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.
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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
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MD 2009 Influenza Anti Virals
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Clinical Need
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Seasonal Influenza
- 5% to 10% world population infected
- Increasing drug resistance
- ‘Flu vaccines often inadequate
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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)
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MD 2009 Influenza Anti Virals
Capability
Key scientific staff :
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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).
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MD 2009 Influenza Anti Virals
Key Advantages
Flu drug candidates: New Design, different mode of action.
 With resultant
 Improved therapeutic performance
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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
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MD 920/921- Advanced Wound
Healing Products
MD 920 – Wound Healing
 Some Characteristics & Mode of Action
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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 ++
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MD 922 – Cosmetics and Skin Health
Products
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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)
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PC 2000, Immune Modulators
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Immune Modulators
Diverse Actions
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Targets
eg 
NIH Support
Modify/Enhance Immune System Response
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Increase Anti Tumor & Anti Infective Cytokines, Killer Cells
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Increase “T” cell (memory) Differentiation
Many/Varied
a) Infections eg. Viral, Bacterial
b) Malignancies
Market Size
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Large
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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
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PC 2000, Immune Modulators
Progress to Date
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Compound Synthesis and Selection
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“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
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MD 990, Respiratory Conditions
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Mode of Action
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NOT
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IS
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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
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Ongoing
Satisfactory Safety and Tolerance Studies
Patent Protection Sought
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MD 960, Diabetes
Primary Objective
To Develop a Drug that is –
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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)
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MD 960, Diabetes
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Results to Date
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Hyperglycaemia Normalised 2 Rat Models
Mode of Action
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Insulin Sensitizer – Non PPAR
Inhibition of PTP’ase
Induction of Nitric Oxide
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Additional Characteristics
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Positive Vascular Effects., Important to FDA
Orally Bioavailable, Good Safety Profile
Additional PoC Cost ~$200k
Patents granted, U.S., China, Europe etc.
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Aus Bio’s MD 2001 Project
Gilax
“a safe and effective gut cleanser”
Some features:
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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)
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