Biotron Limited · ASX:BIT
Biotron — Shareholder Meeting (November 2010)
22 slides from Biotron's shareholder meeting presentation, Nov 26, 2010
Slide 1: Presentation to Annual General Meeting (ASX cover letter)
Level 2, 66 Hunter Street Sydney NSW 2000 For personal use only Tel: (61-2) 9300 3344 Fax: (61-2) 9221 6333 E-mail: pnightingale@biotron.com.au Website: www.biotron.com.au 26 November 2010 The Manager Companies ASX Limited 20 Bridge Street SYDNEY NSW 2000 (22 pages by email) Dear Madam, PRESENTATION
Slide 2: AGM November 2010
For personal use only ASX:BIT AGM 26 November 2010
Slide 3: Key Highlights for 2009/2010
Key Highlights for 2009/2010 For personal use only • Successful completion of Phase Ib clinical trial of BIT225 (BIT225-003) in HCV-infected patients • Appointment of experienced CRO specialising in implementation of HIV and HCV clinical trials in South America and Asia • Progress with HCV program •
Slide 4: Core Technology
Core Technology For personal use only • Identification of new class of viral proteins called viroporins – Small hydrophobic proteins with ion channel activity – Key roles in production and release of infectious virus – Present in influenza (M2), HIV (Vpu), Hep C (p7), Dengue (M) , SARS (E) and other
Slide 5: Pipeline
Pipeline For personal use only • Two clinical phase programs: – Hepatitis C virus(BIT225) and HIV – Both have very large, expanding world markets • Current status of pipeline: Clinical Trials Project Target Discovery Preclinical Phase I Ph Ib/IIa Ph II PoC Hep C p7 HIV Vpu Dengue M protein + other t
Slide 6: Hepatitis C Virus – The Silent Killer
Hepatitis C Virus – The Silent Killer For personal use only • 170 m people infected worldwide; 4 m patients in US (2.7m chronic infection) • Majority remain asymptomatic for decades before developing cirrhosis or liver cancer • US surgeon general considers hepatitis C is one of the most significant
Slide 7: Hep C – An Expanding Market
Hep C – An Expanding Market For personal use only Worldwide market ~US$2.8 billion; predicted to expand to >US$10 billion as new, safer drugs enter the market. Only small percentage currently receive treatment. USA and Europe represent major markets but other, larger markets are emerging. Smith Natu
Slide 8: Hep C Lead Product – BIT225
Hep C Lead Product – BIT225 For personal use only BIT225 is a new investigational oral small molecule drug in development for treating Hep C infection Completed two clinical trials: Phase Ia – Placebo-Controlled, Randomized Study of the Safety and Pharmacokinetics of BIT225 in Healthy Voluntee
Slide 9: BIT225 Clinical Information
BIT225 Clinical Information For personal use only First-in-class drug targeting p7 protein of Hep C virus p7 - Critical role in production of infectious Hep C virus in infected cells Proposed as new target for therapeutic intervention Phase Ia results indicated that BIT225 was well-tolerated
Slide 10: Strategies for HCV Drug Development – Initially Focused Around SoC
Strategies for HCV Drug Development – Initially Focused Around SoC For personal use only SoC: STAT-C = Specifically- ‘Add-on’ STAT-Cs to Interferon (IFN) – effective Targeted Antiviral Therapy current standard of against some genotypes; care for HCV immunologic role - Triple therapy, either e.g. Pro
Slide 11: Future STAT-C Treatment Strategies
Future STAT-C Treatment Strategies For personal use only Potential to be add-on to current SOC Potential to be treatment included in future IFN/ribavirin-free therapies NOW HCV market evolution
Slide 12: Specific Classes of STAT-Cs in Development
SPECIFIC CLASSES OF STAT-Cs in DEVELOPMENT For personal use only PHASE PROTEASE POLYMERAS P7 –specific INHIBITORS E INHIBITORS (PI) INHIBITORS (nuc/non-nuc) I 6 0/5 II 6 3/5 1 (BIT225) III Boceprivir (SP) 0 Telaprevir (VTX) Likely to be approved in 2011; high pill burden and side effects Approved 0
Slide 13: HCV Key Unmet Needs
HCV KEY UNMET NEEDS For personal use only INDUSTRY WISH-LIST BIT225 Increased efficacy in genotype 1 patients Active against genotype 1 in vitro Increased efficacy in non-responders Unknown at this stage Better tolerability Promising safety data in Phase Ia and Ib trials Increased efficacy in HIV/HC
Slide 14: Rationale for Phase IIa Hep C Trial
Rationale for Phase IIa Hep C Trial For personal use only • Focused on developing saleable product to a pharmaceutical partner(s) • Future Hep C therapies expected to be a cocktail of drugs – In short-term new drugs to be used with current approved drugs interferon (IFN) and ribavirin – Industry foc
Slide 15: Hep C Phase II Combination Trial
Hep C Phase II Combination Trial For personal use only Ph II Trial Period Trial design 0 2 4 Weeks 44 wks BIT225 (400mg) 8 pts + IFN/ribPlacebo Interferon + Ribavirin BIT225 (200 mg) Interferon + Ribavirin 8 pts + IFN/rib BIT225 (400 mg) Interferon + Ribavirin 8 pts + IFN/rib – Pts randomly assigned
Slide 16: Very Strong Competitive Position
Very Strong Competitive Position For personal use only • Successfully completed TWO human trials of BIT225 • Good safety and efficacy results • Potential to combine with current or next generation Hep C drugs • BIT225 is an oral drug (tablet) – current Hep C drugs are injectable • Strong patent prot
Slide 17: Biotron's HIV Clinical Program
Biotron’s HIV Clinical Program For personal use only • First-in-class new anti-HIV drug targeting Vpu • New mode of action – inhibits budding of virus from infected cells • Targets HIV in viral reservoirs in vivo • Reservoirs are last of the holy grail in HIV • No existing drugs target this source o
Slide 18: HIV Phase Ib/IIa Proof-of-Concept Trial
HIV Phase Ib/IIa Proof-of-Concept Trial For personal use only Proposed trial design: Days 0 14 28 6 - 10 pts Placebo Drug-free follow-up 6 - 10 pts Drug (200mg 2x daily) Drug-free follow-up • Phase Ib/IIa trial protocols finalised • 12 - 20 subject trial in HIV+ patients •Trial designed to demonstra
Slide 19: Update on Early Stage Antiviral Programs
Update on Early Stage Antiviral Programs For personal use only • HIV • BIT225 has shown activity in dendritic cells – the first cells to be exposed to HIV at the point of infection • Exploring whether BIT225 could be used to prevent establishment of HIV infection (oral microbicide) • Dengue • Resear
Slide 20: Other Activities during 2009/10
Other Activities during 2009/10 For personal use only • Focus on increasing profile to local and international investment community, pharma companies, journalists and scientific opinion leaders • Road shows leading up to capital raising in early 2010 and beyond • International Investor Showcases in
Slide 21: Summary
SUMMARY For personal use only • Biotron has a strong competitive position in a high profile therapeutic area • New mode of action drug for HCV • Phase IIa clinical trial in progress • Strong patent position (applications for drug itself as well as usage) • New mode of action drug for HIV - Ib/IIa tr
Slide 22: Contact: Dr Michelle Miller, Managing Director
For personal use only Dr Michelle Miller Managing Director +61 2 9805 0488 +61 412 313329 mmiller@biotron.com.au www.biotron.com.au