Synergistic Advantages of Drug Repurposing and Clinical Trial Off-shoring to India August 19, 2007 John Maki President and CEO

2 Pipeline of Cancer Products 2008 Product Indication Pre- clinical Proof-of-Concept Phase 3 Pilot TrialPhase 2 VT-122 Cachexia VT-211 Mucositis VT-310 Fatigue

3 Understanding Weight Loss Weight Loss Nutrition Inflammation ANS Dysregulation Neuro-endocrine- Immune activation Nutrition X Severe Stress ChronicAcute Cachexia NSAID Beta Blocker Anorexia Malnutrition FunctionDiet Starvation Slower Metabolism Systemic Inflammatory Response (SIRS) Normal response to severe injury, trauma or infection Faster Metabolism

4 Enrollment Criteria Rapid loss: >5% weight loss in 2 vs. 6 months Advanced cancer: Stage IV Elevated heart rate Able to eat food Severe stress, not malnutrition driven cachexia

5 Confounding Variables SingleMultiple OnSomeVery Many OffFewMany Cancer Types Therapy Status

6 Enrollment Challenges 90+ sites required to enroll 45 subjects

7 Off Shore Development 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) Optimal enrollment AND low cost

8 Repurposing/Off shoring Synergy 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 Synergy Creates Practical and Ethical Option

9 Off Shoring Locations Latin America Eastern Europe Africa China India Considerations: Population, Capability, Risks, Language, Costs

10 India: Concentrated Population Equivalent of entire US population In 31 major urban centers

11 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

12 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

13 Vicus Infrastructure Reliance Mumbai Vicus India Bangalore (2 staff) Contract Manufacturers Vicus U.S. Newark/Delhi 14 Hours (2 staff)

14 Vicus Clinical Sites Nashik Pune Bangalore Delhi Kolkatta Patna (Satellite) 5 sites + 1 satellite 10 million population base

15 Cachexia Time Line Q3 06Q4 06Q1 07Q2 07Q3 07 FDA Pre-IND 3 months Submit IND Accept in 23 days Vicus Hire Indian CRO Recruit sites Recruit Indian team DCGI Submit Accept 6 weeks IEC SubmitAccept 2-12 weeks Subjects 209(July)

16 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