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Synergistic Advantages of Drug Repurposing and Clinical Trial Off-shoring to India August 19, 2007 John Maki President and CEO Pipeline of Cancer Products Product Indication Preclinical Proof-of-Concept Pilot Trial Phase 2 Phase 3 VT-122 Cachexia VT-211 Mucositis VT-310 Fatigue 2008 2 Understanding Weight Loss Weight Loss X Nutrition Severe Stress Malnutrition Chronic Function Anorexia Nutrition Acute Diet Starvation Slower Metabolism Systemic Inflammatory Response (SIRS) Neuro-endocrineImmune activation NSAID Normal response to severe injury, trauma or infection Beta Blocker ANS Dysregulation Inflammation Cachexia Faster Metabolism 3 Enrollment Criteria Severe stress, not malnutrition driven cachexia •Rapid loss: >5% weight loss in 2 vs. 6 months •Advanced cancer: Stage IV •Elevated heart rate •Able to eat food 4 Confounding Variables Therapy Status Cancer Types Single Multiple On Some Very Many Off Few Many 5 Enrollment Challenges 70 60 50 40 30 20 10 0 60 30 M on th s 0.6 6 en t 1.2 Co ns o Ch em N o ch e Ca N SC LC 6 xi a Subjects Per Site Not On Chemotherapy 90+ sites required to enroll 45 subjects 6 Off Shore Development Optimal enrollment AND low cost •Population, practice patterns and participation •12 to 18x more subjects per site 2x+ times more patients per investigator 3x+ more not on chemotherapy 3x+ participation rates •5 to 7 sites versus 90+ sites •80% cost savings (fixed not variable costs) 7 Repurposing/Off shoring Synergy Synergy Creates Practical and Ethical Option •High standard of ethics combined with many years of clinical experience •No first in human regulatory limitation •Leverage 505(b)(2) •Investigator experience with class of drug •Access to drug, especially generics 8 Off Shoring Locations Considerations: Population, Capability, Risks, Language, Costs Eastern Europe China Latin America India Africa 9 India: Concentrated Population Equivalent of entire US population In 31 major urban centers 10 India: Significant Capability •300 plus experienced clinical sites •Fully equipped with sponsor-initiated improvements •International and Pan-Indian CROs •Expedited approval for FDA-approved studies 11 India: Reduced Risks •60% of the MNCs are conducting studies in India •208 studies underway (49 P2 and 131 P3) •100s of site “audits” by multiple sponsors/CROs •Data from studies submitted to FDA and EMEA •Two FDA and EMEA audits noted no serious findings 12 Vicus Infrastructure Vicus U.S. Newark/Delhi 14 Hours (2 staff) Reliance Mumbai Vicus India Bangalore (2 staff) Contract Manufacturers 13 Vicus Clinical Sites Delhi Patna (Satellite) Nashik Kolkatta Pune Bangalore 5 sites + 1 satellite 10 million population base 14 Cachexia Time Line FDA Vicus DCGI IEC Subjects Q3 06 Q4 06 Pre-IND 3 months Submit IND Accept in 23 days Hire Indian CRO Recruit sites Q1 07 Q2 07 Q3 07 Recruit Indian team Submit Accept 6 weeks Submit Accept 2-12 weeks 20 9 (July) 15 Summary •Off-shoring enables testing of repurposed drug hypothesis in human models -Enables optimal clinical trial design to reduce risks -Significantly improves recruitment rate and costs •Repurposing synergy makes off-shoring practical •India offers advantages – especially for start-ups •Local presence and service providers key to success •VT-122 provides proof-of-concept of advantage 16