Slide 1: Biotron Limited (ASX:BIT) Biotech Showcase
BIOTRON LIMITED (ASX:BIT) Biotech Showcase Room Mission II Tuesday, 14 Jan 2014
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: Biotron Limited Overview
Biotron Limited Overview • Clinical stage antiviral drug development company • Clinical programs for Hepatitis C virus (HCV) and HIV • Earlier stage programs include Dengue and others • Headquartered in Sydney, Australia • IPO Jan 2001 (ASX:BIT) • Key recent highlights • Nov 2013 – Commenced Phase 2
Slide 4: Biotron - Advanced Pipeline of Clinical Programs
Biotron - Advanced Pipeline of Clinical Programs VIRAL INDICATION DISCOVERY PRECLINICAL PHASE 1a PHASE 1b PHASE 2a PHASE 2b STATUS TARGET • Ph 2a complete; Hep C p7 • Ph 2b (3 mth dosing) in progress HIV Vpu • Ph 2a complete • Ph 2 completed HIV/Hep C Vpu/p7 clinical phase Next • Ready for IND- gene
Slide 5: Hepatitis C Virus – The Silent Killer
Hepatitis C Virus – The Silent Killer • 180 m people infected worldwide (3% world population) • 130 m are chronically infected; • 4 m patients in US (2.7 m chronically infected) • Majority of infected patients remain untreated or untreatable • Standard of care is pegylated interferon and ribavirin (
Slide 6: Hepatitis C Virus – Recent Advancements
Hepatitis C Virus – Recent Advancements • Industry focus on developing direct-acting antiviral (DAA) treatments that are: • Safe (no PEG/RBV) • Highly effective against all genotypes • Convenient (i.e. oral) • Shorter treatment duration (ideally 4 – 6 weeks) • Cost effective • Treatment of HCV requi
Slide 7: Hepatitis C Virus – Recent Advancements
Hepatitis C Virus – Recent Advancements • BUT these new treatments don’t cover everything on the wish-list i.e. • Not equally effective against ALL genotypes • Still require RBV for maximal effect • 12 weeks minimum treatment (24 weeks for gen 3) • High cost (SOF expected to cost $84,000 for 12 week
Slide 8: Hepatitis C Virus – Market Opportunity
Hepatitis C Virus – Market Opportunity Points to note: - USA and Europe represent major markets but other, larger markets are emerging. - IFN/RBV likely to remain central to treatment in these other countries due to costs - Add-ons to IFN/RBV in these countries may shorten treatment times and improv
Slide 9: BIT225 – New Class of HCV DAA Drug
BIT225 – New Class of HCV DAA Drug Novel, oral, small molecule compound ENTRY INHIBITORS Only one of its class (p7 inhibitor) in clinical trials POLYMERASE/PROTEASE INHIBITORS e.g. Inhibits viral assembly; active at later stage of virus Sofosbuvir/Simeprevir life cycle to polymerase and protea
Slide 10: BIT225 – Proven Clinical Activity Against HCV
BIT225 – Proven Clinical Activity Against HCV BIT225 Interferon + Ribavirin BIT225-005 Placebo 0 4 wks 12 wks 48 wks 12 WEEKS 48 WEEKS Treatment Early Virological Response* Sustained Virological Response* 400 mg BIT225 + IFN/RBV 86% 100% 200 mg BIT225 + IFN/RBV 88% 88% Placebo + IFN/RBV 63% 75% *vir
Slide 11: HCV Phase Three-Month Dosing Trial BIT225-008
HCV Phase 2 Three-Month Dosing Trial BIT225-008 BIT225 Interferon + Ribavirin Placebo 0 4 wks 12 wks 24 wks 48 wks - Randomised, placebo-controlled, double-blind trial (end for Gen 3) (end for Gen 1) - Treatment naïve, HCV gen 1 and 3 - 3 months dosing with BIT225 in combination with IFN/RBV - Using
Slide 12: HIV/HCV Co-infected Population
HIV/HCV Co-infected Population • One third of HIV-positives are also infected with HCV • Rapid progression to liver failure • Respond poorly to IFN/RBV • ~ 19% SVR rate • Often an after-thought in trials of new DAAs • Drug-drug interactions limits use of protease inhibitors (i.e. Boceprevir, Telapre
Slide 13: BIT225 – HIV / HCV Co-Infected Trial (BIT225-006)
BIT225 – HIV / HCV Co-Infected Trial (BIT225-006) BIT225 Interferon + Ribavirin ART 0 1 wks 5 wks 48 wks • Phase 2 HIV/HCV trial - completed clinical phase in July 2013 – Genotypes 1 and 3; 28 days dosing in combination with IFN/RBV – Treatment-naïve to HCV treatment with RBV and/or IFN; HIV control
Slide 14: BIT225 – HIV / HCV gen 3 – Proven Efficacy
BIT225 – HIV / HCV gen 3 - Proven Efficacy • At 12 weeks - All HCV genotype 3 HCV RNA Change from baseline - G3 patients who completed treatment 1 HCV RNA (Baseline adjusted log10 BIT225 603 - GT3a were clear of virus 0 602 - GT3a -1 606 - GT3a • Rate of decline in virus levels increased after addit
Slide 15: HIV – Towards a Cure
HIV – Towards a Cure • 34 million people worldwide living with HIV • Market (US and Europe) is currently US$13.36 billion p.a. • Market expected to expand to US$20 billion by 2016 • New drugs have improved the quality of life for HIV patients and prevented the virus from developing into AIDS. • Once
Slide 16: BIT225 and HIV
BIT225 and HIV • BIT225 has potent anti-HIV activity – Targets Vpu protein of HIV * • Similar class of protein to HCV p7 – Unique mode of action targets HIV “hiding” in long-lived macrophage reservoir cells +BIT225 • Reservoirs are last of the holy grail in HIV • No existing drugs target this source
Slide 17: BIT225 – Proven Clinical Activity Against HIV
BIT225 – Proven Clinical Activity Against HIV 16 • Phase 1b/2a randomised, placebo controlled, double-blind trial Placebo BIT225 HIV-1 Replication (pg/200uL) 14 – 24 patients, HIV-1 positive, treatment-naïve 12 – 10 days dosing with BIT225 (monotherapy) 10 8 • Results demonstrated that: 6 1. BIT225
Slide 18: BIT225 – Multiple Market Opportunities
BIT225 –Multiple Market Opportunities • Hepatitis C • Potential for future combination cocktails with polymerase and protease inhibitors • Unique mode of action • Good drug-drug interaction profile • Limited alternative classes for combinations (prevention of resistance) • Potential to fill gaps lef
Slide 19: Dengue Virus Program
Dengue Virus Program • 2.5 billion people (40% world population) live in areas at risk of Dengue • A leading cause of illness and death in tropics and subtropics • ~100 million people infected yearly • No approved vaccine or therapy • Transmission is by mosquito; most prevention programs target the
Slide 20: Biotron Outlook 2013/14
Biotron Outlook 2013/14 4Q13 1Q14 2Q14 3Q14 4Q14 4Q13 - Commence Mid ‘14- HCV Ph2 HCV (3 month Complete Preliminary, dosing with IFN/RBV) enrolment of interim data (BIT225-008) BIT225-008 IND from Ph 2, 3 Submit an month HCV Investigational New trial (BIT225- Drug ('IND') 008) application for BIT225
Slide 21: Key Financials and Facts
Key Financials and Facts KEY FINANCIALS BOARD AND MANAGEMENT BIOTRON ASX Code LIMITED price BIT history chart Mr Michael Hoy Chairman Recent Share Price (10 Jan ‘14) A$0.085 Dr Michelle Miller Managing Director & CEO 52 Week High A$0.15 Dr Denis Wade Non-Executive Director 52 Week Low A$0.08 Dr Susa
Slide 22: Dr Michelle Miller Managing Director
Dr Michelle Miller Managing Director +61 412 313329 mmiller@biotron.com.au www.biotron.com.au