Biotron Limited · ASX:BIT
Biotron — Shareholder Meeting (October 2008)
22 slides from Biotron's shareholder meeting presentation, Oct 13, 2008
Slide 1: Biotron AGM 13 October 2008
Biotron AGM 13 October 2008
Slide 2: Biotron Ltd (ASX:BIT)
BIOTRON LTD (ASX:BIT) • 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 B virus 1 Biotron Lim
Slide 3: Key Highlights
KEY HIGHLIGHTS • 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 and new HCV drugs 2 B
Slide 4: BIT – Pipeline of Antiviral Products
BIT – PIPELINE OF ANTIVIRAL PRODUCTS DISCOVERY LEAD PRECLINICAL CLINICAL OPTIMISATION VIRION HIV HCV Flu Dengue Other Biotron’s Project Pipeline by Stage of Development 3 Biotron Limited
Slide 5: Hepatitis C Virus (HCV) – The Silent Killer
HEPATITIS C VIRUS (HCV)- THE SILENT KILLER • 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 public health thr
Slide 6: HCV – An Expanding Market
HCV – AN EXPANDING MARKET 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 Reviews Drug Discover
Slide 7: BIT225 – A New Drug for Treatment of HCV
BIT225 – A NEW DRUG FOR 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 with the current approve
Slide 8: Completed Successful Phase I Clinical Trial of BIT225
COMPLETED SUCCESSFUL PHASE I CLINICAL TRIAL OF BIT225 • 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 – Achieved estimated the
Slide 9: HCV Clinical Trial
HCV CLINICAL TRIAL 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 sites (Sydney and Brisba
Slide 10: Competitive Advantage
COMPETITIVE ADVANTAGE • 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 to facilitate developm
Slide 11: Business Strategy
BUSINESS STRATEGY • 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 of approved product •
Slide 12: Av. Terms for Clinical Deals
AV. TERMS FOR CLINICAL DEALS (SOURCE: RECOMBINANT CAPITAL) 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 $5 million $10 million
Slide 13: HIV - High Growth Market
HIV - HIGH GROWTH MARKET • 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 14: New Treatments Needed
NEW TREATMENTS NEEDED • 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 attack the virus in ne
Slide 15: BIT225 & HIV
BIT225 & HIV • 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 strains of HIV • Syner
Slide 16: HIV Program
HIV PROGRAM • 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 during second half of 2008
Slide 17: Financial Summary
FINANCIAL SUMMARY • Shares on issue: 104 m • Unlisted options: 7.1 m • Cash at 30 June 2008: A$2.06m 16 Biotron Limited
Slide 18: Dr Michelle Miller, Chief Executive Officer
Dr Michelle Miller Chief Executive Officer 02 9805 0488 [email protected] www.biotron.com.au
Slide 19: Commentary for a Presentation to the 2008 Annual General Meeting
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. Slide 2 The last 12 months have seen significant advances on clinical progression of Biotron Limited's ('Biotron' or the 'Company') antiviral d
Slide 20: Commentary: 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 21: Commentary: 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 22: Commentary: Slides 15-16
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