Strategic Drug Repositioning Exploit Opportunities and Accelerate R&D by Re-profiling Your Drugs ____________________________

William J. Garner, MD MPH Managing Director Founded EGB Advisors in ’00 to “Drug Hunt” Author, Garnering Capital (Amazon & Kindle) Roche/Wall Street Founder of 4 repositioning companies, 3 public –Arbitrage over time and geography –~$15M over three years to a new NDA Histopathology, Columbia-Presbyterian/Master of Public Health, Harvard

Overview The Promise of Drug Repositioning What makes a repositioned drug successful? How are we to overcome the barriers to succeed? Who has helped to make improvements in the field? What does the future hold?

Introduction The costs associated with product development have increased dramatically while venture capital investment from ‘00 to ‘12 for early stage technologies has been limited. Identifying key issues related to successful financing, commercialization, or partnering requires careful analysis and strategic planning.

What makes a repositioned drug successful? Technology Assessment –Unmet Medical Need Addressed –Reimbursement –Plan and execute Proof-of-Concept, and next- step studies, to increase value

How are we to overcome the barriers to succeed? –IP creation/analysis Pre-clinical, pre-formulation studies –Regulatory strategies

Our Experiences Repositioning Drugs Oncology – DelMar Pharma (DMPI) & Update Pharma, Inc. –Each >40 clinical trials and an Ex-US approval Urology – Urigen (URGP) –Procedure Code & Phase 2 Data Driven Pulmonology – Invion (ASX:IVX) formerly Inverseon

Who has helped to make improvements in the field? –GSK Carvedilol To this day, titration packs provide market exclusivity in some markets Billions in new sales - Celgene –Academics Elmiron for Interstitial Cystitis, $200M per year