Biotron Limited · ASX:BIT
Biotron — Shareholder Meeting (November 2011)
18 slides from Biotron's shareholder meeting presentation, Nov 22, 2011
Slide 1: AGM 22 November 2011
Biotrtron AGM 22 November 2011 ASX: BIT
Slide 2: Forward Looking Statements
Forward Looking Statements This presentation may contain forward‐looking statements with respect to the financial condition, results and business achievements/performance of Biotron Limited and certain of the plans and objectives of its management. These statements are statements that are not histor
Slide 3: Key Highlights for 2010/2011
Key Highlights for 2010/2011 • HCV Program • Successful completion of Phase 2a clinical trial (BIT225-005) of BIT225 in HCV-infected patients in combination with standard of care • HIV Program • Finalisation of design of Phase Ib/2a trial (BIT225-004) of BIT225 in HIV-infected patients • Ethics and
Slide 4: Biotron's Pipeline
Biotron’s Pipeline • Two clinical phase programs: – Hepatitis C virus and HIV Clinical Trials Project Target Discovery Preclinical Phase Ia Ph Ib Ph 2a Ph 2b Hep C p7 HIV Vpu Dengue M protein
Slide 5: Hepatitis C Virus – The Silent Killer
Hepatitis C Virus – The Silent Killer • Leading cause of chronic liver disease and transplants • 180 m people infected worldwide (3% world population); 130 m are chronically infected • 4 m patients in US (2.7 m chronically infected) • 70% will develop liver diseases including cirrhosis and liver can
Slide 6: Hep C – An Expanding Market
Hep C – An Expanding Market Worldwide market ~US$2.8 billion; predicted to expand to >US$10 billion as new, safer drugs enter the market. USA and Europe represent major markets but other, larger markets are emerging. Smith Nature Reviews Drug Discovery 5, 715–716 (September 2006)
Slide 7: BIT225 and Hepatitis C – Phase 1a
BIT225 and Hepatitis C – Phase 1a • New investigational oral drug for treating HCV infection • First in class; targets p7 protein – essential for virus assembly and release • Phase Ia (BIT225-001) – single dose study (35 – 600 mg) in healthy volunteers. • Completed 2007 • 48 subjects • BIT225 well-t
Slide 8: BIT225 and Hepatitis C – Phase 1b
BIT225 and Hepatitis C – Phase 1b • Phase Ib (BIT225-003) – 7-day dosing with drug or placebo in 18 HCV- infected patients. • Completed 2009 • 18 subjects • Different genotypes and past-treatment history • BIT225 significantly reduced HCV levels compared to placebo (p=0.0002) • First indication that
Slide 9: BIT225 and Hepatitis C – Phase 2a
BIT225 and Hepatitis C – Phase 2a 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 – Protocol BIT225-005 – Pts randomly assigne
Slide 10: BIT225 and Hepatitis C – Phase 2a (cont)
BIT225 and Hepatitis C – Phase 2a (cont) • Preliminary results released Oct 2011 • BIT225 treatment resulted in ~1 log (i.e.10-fold) improvement in viral load reduction over and above IFN and ribavirin over the 28 days of treatment - Clear demonstration that this first in class, direct-acting antivi
Slide 11: BIT225 Commercialisation Strategy – Hepatitis C
BIT225 Commercialisation Strategy – Hepatitis C • Documented need for new antiviral drugs; licensing space is still very active • 18 Oct 2011 - Roche acquired Anadys (NASDAQ:ANDS), with Phase 2b and Phase 1 HCV programs, for US$230 million • BIT225 is well-positioned • First in class drug • Potentia
Slide 12: BIT225 and HIV
BIT225 and HIV • Current international focus on strategies for elimination or cure of HIV • Current HIV treatments do not completely eliminate virus from the body • Biotron is well positioned with its HIV drug targeting virus in the reservoir cells • Prevents production of infectious virus in reserv
Slide 13: BIT225 and HIV – Phase 1b/2a Trial
BIT225 and HIV – Phase 1b/2a Trial Days 0 10 20 8 pts Placebo Drug-free follow-up 16 pts 400 mg BIT225 Drug-free follow-up • Protocol BIT225-004 • 24 subjects to be enrolled • Treatment-naïve, high virus load and relatively high T-cell counts •Trial designed to demonstrate proof-of-concept i.e. can
Slide 14: BIT225 Commercialisation Strategy – HIV
BIT225 Commercialisation Strategy – HIV • 39.5 million people living with HIV/AIDS • 4.3 million people newly infected with HIV p.a. • 2.9 million people die of HIV/AIDS-related causes p.a. • US market alone worth >US$3.3 billion p.a.; global market is worth >US$9 billion p.a. • Reservoir eliminatio
Slide 15: BIT225 Commercialisation Strategy – HIV/HCV Co-infected
BIT225 Commercialisation Strategy – HIV/HCV Co-infected • The US and European regulatory agencies (FDA and EMEA) have clearly stated their enthusiasm for trialing and developing new HCV drugs in hard to treat populations • These include the HIV/HCV co-infected population • Up to 30% of HIV-infected
Slide 16: Update on Early Stage Antiviral Programs
Update on Early Stage Antiviral Programs • 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 • Research program with Univer
Slide 17: (Near) Future Directions
(Near) Future Directions • Formulation studies of BIT225 into capsule/tablet format • 3-month toxicology studies in animals • Investigate potential trial design(s) for next trial(s) – 3-month dosing with SOC (+/-IFN) – Studies against other genotypes – Combination with other new classes of anti-HCV
Slide 18: Dr Michelle Miller, Managing Director
ASX:BIT Dr Michelle Miller Managing Director +61 2 9805 0488 +61 412 313329 mmiller@biotron.com.au www.biotron.com.au