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GTX: Filling the gap

Biotechnology & Pharmaceutical Solutions. GTX: Filling the gap. A recommendation to Cure on Gastrex drug license opportunities. Richard Hernandez, MBA Liying Jin, MS Statistics Selina Tirtajana, MPH Mike Ran Zou, PhD Pathology. * Candidates. YBPS Marketing Case Competition.

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GTX: Filling the gap

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  1. Biotechnology & Pharmaceutical Solutions GTX: Filling the gap A recommendation to Cure on Gastrex drug license opportunities Richard Hernandez, MBA Liying Jin, MS Statistics Selina Tirtajana, MPH Mike Ran Zou, PhD Pathology * Candidates YBPS Marketing Case Competition

  2. Problem Statement • IBD is a chronic inflammation of the gastrointestinal tract. Two major types of IBD are Crohn’s Disease (CD) and Ulcerative Colitis (UC) – which affect different parts of the GI tract. • Currently, there are unmet needs in IBD therapy and Cure has been presented with licensing opportunities (GTX-001 & GTX-002) from Gastrex that can potentially fulfill these needs. • Based on pre-clinical studies results and market analysis of these two drugs, we will provide recommendation for Cure.

  3. IBD Path physiology Antigen GI Flora Epithelium Antigen Processing & Presentation, Activation of Macrophages 1 Intestinal Lumen Macrophage 1 2 Monocytes Antigen Recognition & Activation of CD4+T Cell Neutrophils Activated T-Cell Generation of Th1/Th2 Response 3 Macrophage Activated Macrophage Production of Proinflammatory Cytokines 4 2 Recruitment, Migration, and Adhesion IL-4 5 IL-12 Endothelium 3 IFNγ IL-10 Th2 Cell 5 IFNγ TNFα Th1 Cell IFNγ 4 IL-10 TNFα

  4. Prevalence estimates of CD & UC in 2008

  5. GTX-001 shows promising results in pre-clinical studies • GTX-001 is a Monoclonal Antibody that targets VLA-1 • Blocks immune cell trafficking/activation • Pre-clinical (animal studies) results • Improved inflammation score within 4-6 wks • Dose of 2mg/kg intravenously (IV) every 48 hours • Drug tolerated up to 6 mg/kg • Good substitute of existing biologicsin the market GTX-001 VLA-1

  6. GTX-002 shows promising results in pre-clinical studies GTX-002 • GTX-002 is a small molecule compound used to induce T-cell death by targeting IκB Kinase • Effectiveness confirmed by cell-based assays • Pre-clinical (animal studies) results • Remodeling of GI commensal flora indicates altered pathology • Susceptibility to bacterial infection demonstrates immunosuppresion • Improved clinical scores when used in combination with 5-ASA and/or steroids • Good remission, but not induction, agent • Dosage above threshold limit causes liver and kidney toxicity • 50 mg/kg orally or 5 mg/kg IV cell death

  7. Current treatment

  8. Unmet needs in ibd therapy • Mild IBD cases are well served by 5-ASA • Severe patients failed to respond to anti-TNF therapy, which dominates the current market to treat moderate to severe IBD

  9. Potential target market for GTX001 and GTX002 Choice of market segments based on pre-clinical findings GTX001 GTX002

  10. Drug valuation on the market • Assess net value at the present day by discounting cash flow of future revenue and subtracting license fees and other associated payouts. • GTX-001 in the moderate to severe market is sufficient to provide positive NPV • Generic biologics are not competitive • Sensitivity analysis shows that NPV is robust across a spread of various growth rates. • GTX-002 fails to meet a positive NPV

  11. Recommendation: fill the gap! • Purchase license for GTX-001 • There is a demonstrated market need • Added advantage of being a biologic in the US because barriers of entry • NPV is positive and therefore a profitable drug • Do not purchase license for GTX-002 under the current agreements. • Market is well served by other available agents • 56% of market share is required in order to break even in the licensing investment • Consider renegotiating license fee or changing payout structure to delay payment

  12. Q&A

  13. Citation • Title slide image • http://www.scumdoctor.com/images/How-Much-Does-Enbrel-Suppress-The-Immune-System.jpg • Biologics cannot have generic synthetic • http://www.businessweek.com/bwdaily/dnflash/content/mar2007/db20070314_175878.htm • Decision tree for pharmaceutical acquisition. http://www.springerlink.com/content/j28414r31p013331/fulltext.pdf • Sands, Bruce E. Therapy of Inflammatory Bowel Disease, GASTROENTEROLOGY 2000;118:S68–S82

  14. International market for CD? Prevalence Market Share Potential Market Share

  15. International market for UC? Prevalence Market Share Potential Market Share

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