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MIGSYS. Ian Evans, Genetics Max Musicant, SOM Grant Patterson, EPH Jia Kang, Med Informatics Colin Shaw, Nursing. YBPS Case Competition November 20, 2009. Patient Population Market Landscape. Biologics. Biologics. 5-ASAs. Steroids. Steroids. 5-ASAs. Immunomodulators.
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MIGSYS Ian Evans, Genetics Max Musicant, SOM Grant Patterson, EPH Jia Kang, Med Informatics Colin Shaw, Nursing YBPS Case Competition November 20, 2009
Patient PopulationMarket Landscape Biologics Biologics 5-ASAs Steroids Steroids 5-ASAs Immunomodulators Immunomodulators
Target MarketDrug Usage By Disease Severity GTX-001 Biologic Disease Severity Mild Moderate Severe GTX-002 Immunomodulator Disease Severity Mild Moderate Severe
Opportunity 2: Science Behind GTX-001 Mechanism of Action: mAb against 11 integrin
Due Diligence • Released in 2004 for MS, Tysabri was then removed from market in 2005 due to cases of PML • Reintroduced in 2005 and since restricted to smaller patient segment • To date 24 cases of PML found in Tysabri users • GTX-001 is in the same class as Tysabri • mAb against a4-integrin • Decreases extravasation PML (Progressive Mulitfocal Leukoencephalopathy): a rare neurological disease
Recommendation: GTX-002 • Pros • A new class of kinase inhibitor • Cons • Existing market well served by many products • Low market prices for immunomodulators • Signs of side effects in pre-clinical studies • Financial models show inviability Recommendation: NO GO
Recommendation: GTX-001 • Pros • Large moderate and severe segments are underserved • Biologics command high prices in market • Large therapeutic window • Financial model shows significant profitability • Cons • Similar mechanism to existing treatment (Tysabri) • Significant medical risk associated with this class of molecules Recommendation: NO GO
Thank You from MIGSYS Ian Evans, Genetics Max Musicant, SOM Grant Patterson, EPH Jia Kang, Med Informatics Colin Shaw, Nursing
Tysabri, A Risky Proposition • Approved for the indication of CD in 2008 • Strong warnings not to use Tysabri with PML • in family history • Case Report: N Engl J Med 2005;353:362-8. • PML in patients who have received at least 24 infusions ranges from 0.4 to 1.3 per 1,000 in MS patients • CD patients make up only 2% of the Tysabri users • EMEA rejected Tysabri twice in 2007 Previous FDA Alert: [issued 2/2006] The FDA has lifted the clinical hold on Biogen-IDEC's trials of natalizumab for patients with multiple sclerosis (MS). Biogen-IDEC can now resume administration of natalizumab to patients with relapsing-remitting MS who had previously been treated with the drug in clinical trials. Biogen-IDEC had previously suspended marketing of natalizumab and all further dosing of patients in on-going clinical trials. This decision was made after confirmation of one fatal case and one additional case of severely disabling progressive multifocal leukoencephalopathy (PML) in patients receiving natalizumab for MS. A third case of PML, this one fatal, in a patient with Crohn's Disease had been identified shortly thereafter.
