Biotron Limited · ASX:BIT
Biotron — Shareholder Meeting (October 2008)
23 slides from Biotron's shareholder meeting presentation, Oct 13, 2008
Slide 1: Cover letter to ASX for AGM presentation
Level 2, 66 Hunter Street Sydney NSW 2000 Tel: (61-2) 9300 3344 Fax: (61-2) 9221 6333 For personal use only E-mail: pnightingale@biotron.com.au Website: www.biotron.com.au 13 October 2008 The Manager Companies Australian Stock Exchange Limited 20 Bridge Street SYDNEY NSW 2000 (23 pages by email) Dea
Slide 2: AGM 13 October 2008
For personal use only AGM 13 October 2008
Slide 3: Biotron Ltd (ASX:BIT)
BIOTRON LTD (ASX:BIT) For personal use only • Developing world-class drugs to treat viral diseases with unmet medical need & large, expanding markets • Specific focus on HIV and Hepatitis C virus (HCV) • Beyond HIV & HCV, portfolio of promising early stage drug programs for Dengue, flu and Hepatitis
Slide 4: Key Highlights
KEY HIGHLIGHTS For personal use only • Successful completion of underwritten rights issue, raising $2.5 million • Receipt of Commercial Ready grant for Phase I trial of BIT225 • Commencement of Phase Ib/IIa clinical trial of BIT225 in HCV+ patients • Demonstration of synergism of BIT225 with current
Slide 5: BIT – Pipeline of Antiviral Products
BIT – PIPELINE OF ANTIVIRAL PRODUCTS For personal use only DISCOVERY LEAD PRECLINICAL CLINICAL OPTIMISATION VIRION HIV HCV Flu Dengue Other Biotron’s Project Pipeline by Stage of Development 3 Biotron Limited
Slide 6: Hepatitis C Virus (HCV) – The Silent Killer
HEPATITIS C VIRUS (HCV)- 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 signifi
Slide 7: HCV – An Expanding Market
HCV – 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 Nature
Slide 8: BIT225 – A New Drug for Treatment of HCV
BIT225 – A NEW DRUG FOR For personal use only TREATMENT OF HCV • A new drug in development for treatment of HCV • BIT225 is a first-in-class drug – Works in a different, but complementary way to the current approved HCV drugs – Excellent activity against HCV in disease models • Highly synergistic wi
Slide 9: Completed Successful Phase I Clinical Trial of BIT225
COMPLETED SUCCESSFUL PHASE I CLINICAL TRIAL OF BIT225 For personal use only • Completed a Phase I human clinical trial of BIT225 in late 2007 – 40 healthy volunteers dosed with 35, 100, 200 or 400mg BIT225 • No dose-limiting toxicities • Excellent safety profile with good blood levels of the drug –
Slide 10: HCV Clinical Trial
HCV CLINICAL TRIAL For personal use only BIT225-003 – Placebo-controlled, randomised study of safety, PK and antiviral activity of BIT2225 in patients with HCV infection - 3 treatment groups – 35mg and 200mg BIT225 vs placebo - 6 subjects per treatment group - Twice daily dosing for 14 days - Two si
Slide 11: Competitive Advantage
COMPETITIVE ADVANTAGE For personal use only • Antiviral market is attractive: – Patients receive cocktails of drugs which attack viruses in different ways – Market expands as new mode of action drugs are approved • BIT225 is first-in-class – Biotron has back-up drugs and rapid high throughput assay
Slide 12: Business Strategy
BUSINESS STRATEGY For personal use only • Progress BIT225 through Phase IIa, proof-of-concept human trials, then partner with international large biotechnology or pharmaceutical company – Upfront payment at deal signing – Milestone payments as drug progresses in the clinic – Royalty payments on sale
Slide 13: Av. Terms for Clinical Deals
AV. TERMS FOR CLINICAL DEALS (SOURCE: RECOMBINANT CAPITAL) For personal use only PRECLINICAL PHASE I PHASE II Upfront $3-10 million $5-15 million $10-25 million IND $2-5 million NA NA Ph II Start $3-8 million $5-10 million NA Ph III Start $10 million $10-15 million $25 million NDA Filing $5 million
Slide 14: HIV – High Growth Market
HIV - HIGH GROWTH MARKET For personal use only • 39.5 million people with HIV/AIDS at end of 2006 • 4.3 million people were newly infected with HIV in 2006 • In 2006 2.9 million people died of HIV/AIDS- related causes • US market alone worth >US$3.3 billion p.a. 152 Biotron Limited
Slide 15: New Treatments Needed
NEW TREATMENTS NEEDED For personal use only • Resistance is a main cause of antiretroviral therapy failure ~ 26% newly diagnosed patients have resistant strains of virus ~ 78% of late-stage patients develop resistance to existing therapies • Unmet need for new drugs suitable for HAART* therapy that
Slide 16: BIT225 & HIV
BIT225 & HIV For personal use only • BIT225 is a Viral Protein U (Vpu) inhibitor • No existing drugs target HIV Vpu protein – novel mode of action • Disturbs formation of new virus particles through budding process • Reduces infectivity of virus produced by infected cells • Active against resistant
Slide 17: HIV Program
HIV PROGRAM For personal use only • First-in-class new anti-HIV drug • New mode of action • Targets HIV in viral reservoirs in vivo • No existing drugs target this source of HIV in the body • Phase I completed in 2007 • Phase Ib/IIa trial preparation in progress • Aiming to have approvals, etc durin
Slide 18: Financial Summary
FINANCIAL SUMMARY For personal use only • Shares on issue: 104 m • Unlisted options: 7.1 m • Cash at 30 June 2008: A$2.06m 16 Biotron Limited
Slide 19: For personal use only
For personal use only Dr Michelle Miller Chief Executive Officer 02 9805 0488 mmiller@biotron.com.au www.biotron.com.au
Slide 20: Commentary for a Presentation to the 2008 AGM
COMMENTARY FOR A PRESENTATION TO THE 2008 ANNUAL GENERAL MEETING 13 OCTOBER 2008 I am pleased to be able to present this update on the Company’s activities. For personal use only Slide 2 The last 12 months have seen significant advances on clinical progression of Biotron Limited's ('Biotron' or the
Slide 21: Commentary notes (slides 3-4)
Slide 3 Biotron has an impressive portfolio of clinical and preclinical antiviral programs developing drugs targeting HIV, Hepatitis C virus (HCV), Dengue virus and Influenza virus. BIT225 is in clinical trials for treatment of HIV and HCV. In addition, the Company has earlier stage drug programs fo
Slide 22: Commentary notes (slides 8-9)
twice daily, for 14 consecutive days. The secondary objectives are to assess the pharmacokinetics of BIT225 as well as to assess the antiviral efficacy of BIT225 in these patients. Eighteen patients will be randomly assigned to receive one of two dose levels of BIT225 or placebo. The use of two tria
Slide 23: Commentary notes (slides 14-16)
BIT225 has been shown to have good activity against strains of HIV that are resistant to other HIV drugs. In vitro studies have demonstrated that BIT225 is able to improve the activity of current HIV therapies, further supporting its use with existing HIV drugs. Slide 15 BIT225 represents a new, fir