Transcript Strategic Drug Repositioning

• Strategic Drug Repositioning
Exploit Opportunities and Accelerate
R&D by Re-profiling Your Drugs
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[email protected]
+1 917 653-0470
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
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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 nextstep 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