AI assistant
INVION LIMITED — AGM Information 2010
Nov 25, 2010
65148_rns_2010-11-25_5cb1fdb7-80c4-46b5-8b38-489bbaebcd6c.pdf
AGM Information
Open in viewerOpens in your device viewer

Managing Director's Presentation Annual General Meeting 26 November 2010
XToll® and Rheumatoid Arthritis
- XToll® is being developed to address the very large RA market
- XToll® has potential to address the significant unmet needs of RA patients
- Efficacy
- Safety
- Cost of reimbursement of therapy
- Convenience and cost of administering the drugs
- XToll® works differently to any other therapy ie. it is novel and therefore attractive to big pharma

The Rheumatoid Arthritis Therapy market
Global sales of leading RA Therapies 2008 - Total Revenues US\$18.7B


XToll® and the unmet needs of RA sufferers
Safety -
XToll® has so far been administered into over 300 patients safely
Efficacy -
Patients in completed clinical trials in RA and Psoriasis with XToll® have showed significant improvement in their diseases

XToll® and the unmet needs of RA sufferers
Cost of reimbursement of therapies
XToll® has a low cost of goods advantage compared with leading registered RA therapies
Convenience and cost of administering the drugs
XToll® can be delivered cost effectively with subcutaneous dosing at therapeutic levels and at dosing frequencies that are commercially relevant

Other potential Markets for XToll®
Psoriasis -
- Market size in 2008 \$2.4B
- Estimated to grow to \$4.1B by 2015
- High unmet need largely driven by poor safety profile of existing therapies
Lupus –
- Market size in 2008 \$350M
- Estimated to grow to \$4.5B by 2015
- There are no effective treatments for Lupus

Orphan Disease Markets
Orphan diseases –
- rare diseases that affect a small percentage of the population
- in most cases there is no appropriate treatment
Examples and market size of some Orphan diseases –
- Inflammatory Bowel Disease market size in 2009 est. \$5B
- Temporal Arteritis market size in 2009 est. \$500M
- Graft vs Host Disease market size in 2009 est. \$500M



Operational Update
Clinical Development Update
- Recruitment completed with 155 patients enrolled into clinical trial
- Last patient last dose late March 2011
- QC'd data tables and listing available by June 2011
- Expected pharma company review of study data to commence Q2/Q3 2011

Regulatory Update
Preparation of dossier for pre-IND application ongoing
Final studies and reports required for pre-IND application to FDA planned to be completed and available by Q1 2011
Pre-IND meeting with FDA planned for Q2 2011

Intellectual Property
- 73 patents registered or accepted, 94 patents pending
- Cornerstone patent for XToll® issued or granted in key international markets
- Coverage to at least 2023 in all key markets, coverage in the US to at least 2026
- Continue to aggressively file new patents around Cpn10 variants

Capital Raising
Funds raised during the financial year, \$20.3M –
- Pre-IPO, \$12.6M
- IPO, \$7.1M
- Other, \$0.6M
- Recent Rights issue \$9.3M
- Company now fully funded to complete RA clinical trial


