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Cure’s GTX Licensing Opportunity

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Presentation on theme: "Cure’s GTX Licensing Opportunity"— Presentation transcript:

1 Cure’s GTX Licensing Opportunity
One Opportunity Too Good to Miss

2 Summary Cure is considering licensing from Gastrex two potential new drugs to treat Crohn’s Disease and Ulcerative Colitis GTX-001 is a biologic that may be easier to administer and have fewer side effects than biologics currently in use If successful in trials, GTX-001 is likely to be preferred over existing treatments at a price point making licensing profitable GTX-002 is a small molecule kinase inhibitor that may be effective in combination with steroids and/or 5-ASAs, and may replace immuno-modulators for Crohn’s If successful in trials, GTX-002 is likely to be preferred over existing treatments, but at a price too low to make licensing profitable Recommendation: Cure should license GTX-001, but not GTX-002 from Gastrex November 2009 J, P, Morgan and Associates

3 Bowel disease has unmet need
Mild/Moderate Steroids unsafe for long-term use 5-ASAs not always effective with Crohn’s Immuno-modulators have side effects Biologics hard to administer (IV) and can have severe side effects No effective drugs GTX-002 Target Severe GTX-001 Target Refractory November 2009 J, P, Morgan and Associates

4 Ulcerative colitis: Unmet needs
40,000 severe cases fail to respond to Remicade (TNF-a inhibitor). No current alternatives. High need 99,000 severe cases respond to Remicade would benefit from drug that provides longer remission rates and remains effective over time. Moderate need 150,000 mild to severe cases treated with steroids for induction. Moderate need to diminish amount used to minimize side-effects 155,000 mild to severe cases treated with immunomodulators for maintenance. Moderate need for safer alternatives GTX-002 target GTX-001 target November 2009 J, P, Morgan and Associates

5 Crohn’s disease: Unmet needs
65,000 severe cases fail to respond to current TNF-a inhibitors. Tysabri presents safety concerns. High need 145,000 severe cases respond to TNF-a inhibitors. Moderate need for drug with longer remission rates administered subcutaneously 180,000 mild to severe cases treated with steroids for induction. Moderate need to diminish amount used to minimize side-effects 227,000 mild to moderate cases treated with 5-ASAs. Moderate need for drug that increases remission rates 135,000 mild to severe cases treated with immunomodulators for maintenance. Moderate need for safer drug GTX-002 target GTX-001 target November 2009 J, P, Morgan and Associates

6 Market size is sufficient for development
GTX-001 could serve 30% of Biologics; 50% of Refractory patients GTX-002 could serve 80% of 5-ASA Crohn’s; 80% of Steroids and IM patients This shows: GTX-001 wins 30% of Biologics for both diseases and 50% of Refractory market for both diseases (3rd bar is sum of both diseases) GTX-002 wins 80% of target markets, Ims and steroids for both diseases, 5-ASA for Crohn’s only November 2009 J, P, Morgan and Associates

7 Comparison of GTX-001 to competitors
Key + Favorable for patients - Harmful to patients November 2009 J, P, Morgan and Associates 7

8 Comparison of GTX-002 competitors
Key + Favorable for patients - Harmful to patients November 2009 J, P, Morgan and Associates 8

9 Delayed milestone payments lowers cost
Option to license Safe Continue testing: Effective Continue testing: Effective, Favored, Affordable FDA Approval Successful marketing Late-stage withdrawal No FDA Approval Continue testing: Not effective, not favored, or cost-prohibitive Continue testing: Not effective or not favored Unsafe Start Phase I: Human safety/ dosage (63% success) Phase II: Limited human efficacy/ adverse drug reactions (40% success) Phase III: Expanded human efficacy (55% success) FDA Approval (80% success) Phase IV post-market safety tests (86% success) Milestone Payment Milestone Payment Milestone Payment Milestone Payment Success defined as passing stage of trial AND Cure making the decision to move forward with testing November 2009 J, P, Morgan and Associates

10 Milestones Specified Successful in trials on primates
No physical harm evident Human derived biologic Adverse reactions less severe Dose Response Rates equally promising or better than Remicade Compare to Remicade on other metrics Clinical Remission rates Fistula Rates of Recovery –CD FDA approves or drug qualifies for Fast Track Positive post-market study results supporting earlier data $20 Million Payment $50 Million Payment $150 Million Payment $180 Million in overall Payments For GTX-001 only

11 Conclusion/Results: NPV of licensing option
GTX- 001 NPV: $94 million through 2032 Capital recovery by 2026 Conservative assumptions GTX-002 NPV: -$13 million through 2032 Best case scenario Considering only US and EU November 2009 J, P, Morgan and Associates

12 J, P, Morgan and Associates
Sensitivity Analysis Discounted Cash Flows over Time Positive NPV for GTX-001 Robust with Changing Assumptions November 2009 J, P, Morgan and Associates

13 Appendix A: Assumptions
Price=average price of competitors 5 years to maximum adoption rate Population growth rates .5% for UC; for Crohn’s population growth rates in document 50% operating margin Tax percentage = 21.2% from comparables WACC = 6.06% from comparables Clinical trial phase lengths No cannibalization (we are not current producer) Trial success probabilities Cure has ready access to capital for investment Cure has operating profits against which to apply tax credits November 2009 J, P, Morgan and Associates

14 Appendix B: Remicade Clinical Trials Data
Drug Different Dose response rates Clinical remission rates at week 8 Clinical remission rates at week 30 Mucosal healing rates at week 8, at week 30 Rate of discontinuing corticosteroid therapy at week 30 Patients with fistulas recover (CD) GTX-001 Studies ? Remicade (Infliximab) 5mg-69% 10mg-62% compared to 37% of placebo group 5mg/kg compared to 34%, 37% vs 18% in placebo group 62%, 59% vs 34% in placebo group 24%, 19% vs 10% in placebo group 68% vs 28% in placebo group Source:http://www.cigna.com/customer_care/healthcare_professional/coverage_positions/pharmacy/ph_5112_coveragepositioncriteria_infliximab_remicade.pdf

15 Appendix C.1: Financial Model
November 2009 J, P, Morgan and Associates

16 Appendix C.2: Financial Model
November 2009 J, P, Morgan and Associates

17 Appendix E: Comparables
November 2009 J, P, Morgan and Associates


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