Skip to main content

AI assistant

Sign in to chat with this filing

The assistant answers questions, extracts KPIs, and summarises risk factors directly from the filing text.

INVION LIMITED AGM Information 2010

Nov 25, 2010

65148_rns_2010-11-25_5cb1fdb7-80c4-46b5-8b38-489bbaebcd6c.pdf

AGM Information

Open in viewer

Opens 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