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Commercial Assessment of GTX-001 and GTX-002

Commercial Assessment of GTX-001 and GTX-002. November 20, 2009. Team 5 Peter Chen Pasquale Cirone Crystal Gu April Haisu Ma Serina Xiaoqing Tang. A Subsidiary of The Schnappi Corporation. Executive Summary.

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Commercial Assessment of GTX-001 and GTX-002

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  1. Commercial Assessment of GTX-001 and GTX-002 November 20, 2009 Team 5 Peter Chen Pasquale Cirone Crystal Gu April Haisu Ma SerinaXiaoqing Tang A Subsidiary of The Schnappi Corporation

  2. Executive Summary • Severe forms of inflammatory bowel disease (IBD) patients represent the best opportunities for Cure and GTX • Safety, efficacy and innovative mechanism of action of GTX-001 can address the unmet needs of a profitable market • The potential IBD market can support the cost of developing and licensing GTX-001 From our analysis, we recommend licensing GTX-001

  3. Epidemiology 910K 1,107K 1,035K 851K Source: Nguyen et al. 2007, US census, internal analysis

  4. Unmet needs (Crohn’s Disease)

  5. Unmet needs (Ulcerative Colitis)

  6. Clinical Signals for Success What signals (in preclinical and clinical studies) would indicate investigational agents can achieve the desired target product profile? • Early Studies (Preclinical, PhaseI/II) • GTX001; Pharmacokinetics, efficacy with multiple treatments • GTX002; Toxicities are manageable upon scale-up. • Later Studies • Efficacy (Induction, Maintenance models) • Crohn’s Disease Activity Index* • Fistula Response • Ulcerative Colitis Clinical Score** • Rate of Onset • Incidence of side effects (i.e., infections) • Long-Term Efficacy Studies • % Rollover • Benefit over surgery • IBD Questionnaire, QALY Note: * Best WR et al, Gastroenterology 70 (3): 439–44. 1976. ** Feagan et al., Gut 54: 782-8. 2005

  7. Clinical Research Strategy (IBD)

  8. Financial projection (GTX-001) GTX-001 is expected to reach peak sales of $750 million in 5 years Source: Case information, Nguyen et al. 2007, US census, internal analysis

  9. Financial projection (GTX-002) GTX-002 will not be able to generate enough sales to cover its major costs after it is launched Source: Case information, Nguyen et al. 2007, US census, internal analysis

  10. Assessment of Commercial Values • GTX-001 has positive rNPV in both base and high cases • With the approval of expanded indications, GTX-001 is likely to create more value Source: Case information, internal analysis

  11. Final Recommendation • Development of GTX002 for IBD is not recommended for CURE. • Development of GTX001 for IBD is recommended. • Base-market case represents a positive Risk-Adjusted NPV for CURE. • Preclinical drug properties (drug target, safety etc) amenable for IND (assuming humanized MAB). • Target market and indications are favored heavily by KOLs. • Clinical Strategy proposed to mitigate technical and financial risks.

  12. Appendix

  13. Crohn’s Disease Activity Index Remission of Crohn's disease is defined as a CDAI of less than 150. Severe disease was defined as a value of greater than 450. Response defined as a fall of the CDAI of greater than 70 points. Best WR et al, Gastroenterology70 (3): 439–44. 1976.

  14. Rationale for GTX Products Goldstein I, et al., J Clin Invest 112(9): 1444–1454. 2003

  15. Key assumptions Note: * Depending on target indications

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