Biotron Limited · ASX:BIT
Biotron — Shareholder Meeting (November 2013)
26 slides from Biotron's shareholder meeting presentation, Nov 8, 2013
Slide 1: Presentation to Annual General Meeting 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 8 November 2013 The Manager Companies ASX Limited 20 Bridge Street SYDNEY NSW 2000 (26 pages by email) Dear Madam, PRESENTATION
Slide 2: AGM November 2013
For personal use only ASX:BIT AGM 8 November 2013
Slide 3: Milestones 2012/13: Planned vs Achieved
Milestones 2012/13: Planned vs Achieved For personal use only ACTIVITY STATUS OUTCOME Complete Ph 2a HIV trial (1Q2013) " PosiAve data reported Complete Ph 2 HIV/HCV co-‐infected trial (1H2013) " PosiAve data reported Conduct bioequivalence study in healthy volunteers with new BIT225 " PosiAve d
Slide 4: Global Perspectives
GLOBAL PERSPECTIVES For personal use only Progress in development of new HCV drugs has been rapid over last 12 months -‐ Update of field -‐ What does that mean for Biotron’s HCV program? -‐ Update on BIT225 Programs -‐ Outlook
Slide 5: HCV - Background
HCV -‐ Background • 180 m people infected worldwide (3% world populaAon); 130 m are chronically For personal use only infected • HCV is 4x more prevalent than HIV • 4 m paAents in US (2.7 m chronically infected) • 75% are undiagnosed • Baby boomers -‐ >800,000 cases undiagnosed (CDC) • 5x more lik
Slide 6: Current Treatment Options
Current Treatment OpAons • Standard of care treatment has been interferon and ribavirin (IFN/RBV) For personal use only • 48 weeks of treatment • Associated with debilitaAng side effects in many paAents • High drop out rate • IneffecAve in ~50% of cases • Genotype 1 parAcularly resistant to IFN/RBV •
Slide 7: Selected Classes of HCV DAAs
Selected Classes of HCV DAA’s Entry Inhibitors For personal use only Protease Inhibitors (NS3) Polymerase Inhibitors (NS5B) Assembly/budding Inhibitors e.g. BIT225 Drugs must be used in combina1on to minimise virus becoming resistant to drugs
Slide 8: Current HCV DAA Approval Landscape
Current HCV DAA Approval Landscape Protease Inhibitors For personal use only -‐ First generaAon approved in 2011/12 -‐ Boceprevir and Telaprevir -‐ Second generaAon expected to be approved late 2013 -‐ Simeprevir (SIM; Janssen) -‐ Expected to replace Boceprevir and Telaprevir Polymerase Inhibit
Slide 9: Current DAA Treatment Outcomes - Genotype Overview
Current DAA Treatment Outcomes – Gen 1 and 2 Selected Overview For personal use only Genotype 1 -‐ Most common variant in USA, Europe and Australia -‐ New DAAs (with and without IFN+/-‐ RBV); 12 weeks therapy -‐ Overall cure rates (SVR12) -‐ Non-‐cirrhosis ~92% -‐ Cirrhosis ~80% Genotypes 2,
Slide 10: Selected Current DAA Treatment Outcomes - Genotype 3
Selected Current DAA Treatment Outcomes – Genotype 3 For personal use only Genotype 3 -‐ Higher prevalence in lower socio-‐economic groups -‐ Predominant variant in Asia -‐ Large proporAon of future cases expected to be gen 3 (intravenous drug users) -‐ Treatment with new DAA classes is more pr
Slide 11: Why Additional Classes of DAAs Are Still Needed
Why AddiAonal Classes of DAAs Are SAll Needed (For All Genotypes) - SOF, SIM etc have only been assessed under trial conditions For personal use only - Treatment decisions are being made on limited trial data (often Ph 2) - Real world will impact on SVR rates post-approval - Patient compliance with
Slide 12: HIV/HCV Co-Infected Population
HIV/HCV Co-‐Infected PopulaAon • One third of HIV-positives are infected with HCV For personal use only • 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. B
Slide 13: BIT225 and HCV
BIT225 and HCV For personal use only ü Novel, oral, small molecule compound ü Only one of its class (p7 inhibitor) in clinical trials ü Inhibits viral assembly; acAve at later stage of virus life cycle to polymerase and protease inhibitors ü Clinically acAve against HCV genotype 1 (1a and 1b) an
Slide 14: BIT225 - Proven Clinical Activity Against HCV
BIT225 – Proven Clinical AcAvity Against HCV BIT225 For personal use only Interferon + Ribavirin BIT225-‐005 Placebo 0 4 wks 12 wks 48 wks 48 WEEKS 12 WEEKS Treatment Sustained Virological Early Virological Response* Response* 400 mg BIT225 + 86% 100% IFN/RBV 200 mg BIT225 + 88% 88% IFN/RBV Placebo
Slide 15: BIT225 - HIV/HCV Co-Infected Trial
BIT225 – HIV / HCV Co-‐Infected Trial BIT225-‐006 For personal use only 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 combinaAon with IFN/RBV – Treatment-‐naïve to HCV treatment with
Slide 16: BIT225 - HIV/HCV Co-Infected Trial (cont)
BIT225 – HIV / HCV Co-‐Infected Trial (cont) For personal use only HCV RNA Change from baseline -‐ G3 HCV RNA (Baseline adjusted log10 change) 1 PR BIT225 603 -‐ GT3a 0 602 -‐ GT3a -‐1 606 -‐ GT3a 607 -‐ GT3a -‐2 609 -‐ GT3a 610 -‐ GT3a -‐3 611 -‐ GT3a 612 -‐ GT3-‐ -‐4 -‐5 LLQ -‐6 0
Slide 17: BIT225 - HIV/HCV Co-Infected Trial (cont)
BIT225 – HIV / HCV Co-‐Infected Trial (cont) For personal use only • Genotype 1 response was impacted by a geneAc change in IL28B in two paAents – this means that they are unable to respond to IFN/RBV • Data from previous 005 trial demonstrated that BIT225 works in gen 1’s • This trial demonstrates
Slide 18: Why Are We Using IFN/RBV in BIT225 Trials?
Why Are We Using IFN/RBV in BIT225 Trials? For personal use only • Drugs to treat chronic viral diseases such as HIV and HCV can’t be used on their own • IFN/RBV has been the only approved treatment for HCV • Other new DAAs have also been trialled in combination with IFN/RBV • IFN/RBV + DAA combinat
Slide 19: Where Do These Results Position BIT225 in the New DAA World?
Where Do These Results PosiAon BIT225 in the New DAA World? For personal use only -‐ BIT225 works against HCV genotypes 1 and 3 Well posiAoned for genotype 3, which has greatest unmet need -‐ All paAents finishing treatment responded with just 28 days of BIT225 -‐ PotenAal to add to new DAAs e.g.
Slide 20: HIV - Towards a Cure
For personal use only HIV – Towards a Cure • 34 million people worldwide living with HIV • AnA-‐HIV drugs (ART) have improved the quality of life for HIV+ * paAents • BUT – ART does not eradicate HIV infecAon • Sustained, low-‐level HIV replicaAon occurs in ART-‐treated paAents • Reservoirs of in
Slide 21: BIT225 - Proven Clinical Activity Against HIV
BIT225 – Proven Clinical AcAvity Against HIV For personal use only • Phase 1b/2a randomised, placebo controlled, double-‐blind trial (BIT225-‐004) – 24 paAents, HIV-‐1 posiAve, treatment-‐naïve – 10 days dosing with BIT225 (monotherapy) • Results demonstrated that: 1. BIT225 significantly reduces
Slide 22: BIT225 - Stepwise Progression to Commercialisation
BIT225 – Stepwise Progression to CommercialisaAon • Strategy is guided by: For personal use only • Advisory panels of US-based KOLs who are leaders of the field • Interaction and feedback from US healthcare analysts who specialise in antiviral space • Interaction and feedback from potential partners
Slide 23: BIT225 - HCV Phase 2 Three-Month Dosing Trial
BIT225 -‐ HCV Phase 2 Three-‐Month Dosing Trial For personal use only BIT225 Interferon + Ribavirin BIT225-‐008 Placebo 0 4 wks 12 wks 24 wks 48 wks (end for Gen 3) (end for Gen 1) -‐ Randomised, placebo-‐controlled, double-‐blind trial -‐ 3 months dosing with BIT225 in combinaAon with IFN/RB
Slide 24: Biotron Outlook 2013/14
Biotron Outlook 2013/14 For personal use only 4Q13 1Q14 2Q14 3Q14 4Q14 4Q13 -‐ Commence Mid ‘14-‐ Ph2 HCV (3 month Complete HCV dosing with IFN/RBV) enrolment Preliminary, interim (BIT225-‐008) of data from Ph 2, 3 BIT225-‐008 month HCV trial (BIT225-‐008) HIV IND AddiZonal data Submit an from
Slide 25: BIT225 - Multiple Market Opportunities
BIT225 –MulAple Market OpportuniAes • C HepaZZs For personal use only • PotenAal for future combinaAon cocktails with polymerase and protease inhibitors • Unique mode of acAon • Good drug-‐drug interacAon profile • Limited alternaAve classes for combinaAons (prevenAon of resistance) • PotenAal to fil
Slide 26: Dr Michelle Miller, Managing Director
For personal use only ASX:BIT Dr Michelle Miller Managing Director +61 2 9805 0488 +61 412 313329 mmiller@biotron.com.au www.biotron.com.au