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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 November 20, 2009 Team 5 Peter Chen Pasquale Cirone Crystal Gu April Haisu Ma SerinaXiaoqing Tang A Subsidiary of The Schnappi Corporation
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
Epidemiology 910K 1,107K 1,035K 851K Source: Nguyen et al. 2007, US census, internal analysis
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
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
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
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
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.
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.
Rationale for GTX Products Goldstein I, et al., J Clin Invest 112(9): 1444–1454. 2003
Key assumptions Note: * Depending on target indications