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Afinitor life cycle management
- 1. 2008 2010 2011 2012 2013 2014 20152006 2007 2009 Accelerated Approval Subependymal Giant Cell Astrocytoma With Tuberous Sclerosis Complex • Phase I/II study (28 patients) • Open-label, single-arm study • Received Afinitor at a dose of 3 mg/m2 Advanced Pancreatic Neuroendocrine Tumors • Phase III (410 subjects) • Randomized, double-blind, multi-center trial • Subjects received either Afinitor (10 mg/day) or placebo Advanced Renal Cancer • Phase III (416 subjects) • Multicenter, randomized, double-blind study • Subjects received Afinitor (10 mg/day) or placebo Advanced Hormone Receptor+, HER2- Breast Cancer • Phase III (724 women) • Randomized, double-blind, multicenter study • Subjects were treated with Afinitor (10 mg/day) plus exemestane or placebo plus exemestane Renal Angiomyolipoma With Tuberous Sclerosis Complex • Phase III (113 adults) • Double-blind, placebo-controlled trial • Subjects were treated with Afinitor (10 mg/day) or matching placebo Approved March 2009 Phase III Aug 2009 (118 patients) Approved May 2011 Phase III April 2009 (118 patients) Approved April 2012 Phase I Feb 2007 (60 patients) Approved July 2012 Phase III Nov 2006 (416 patients) Approved October 2010 Phase III Dec 2006 (429 patients) Phase III Jul 2007 (410 patients) Phase I July 2007 (88 patients) Phase III Jun/Sept/Oct 2009 (724/721/570 patients) Phase II May 2009 (40 patients) Phase I/II Jan 2007 (28 patients) Afinitor: FDA Approval in Five Indications Since 2009
- 2. Afinitor’s Multiple Approvals Have Boosted Revenues - LCM Well Executed 0 200 400 600 800 1,000 1,200 1,400 1,600 1,800 2009 2010 2011 2012 2013 2014 Afinitor Revenues & FDA Approvals (2009 - 2014) Advanced Renal Cancer (March 2009) Advanced Pancreatic Neuroendocrine Tumors (May 2011) Renal Angiomyolipoma With Tuberous Sclerosis Complex (April 2012) Advanced Hormone Receptor+, HER2- Breast Cancer (July 2012) Subependymal Giant Cell Astrocytoma With Tuberous Sclerosis Complex (October 2010) YEAR REVENUE GROWTH (From Previous Year) 2010 $ 173 M 2011 $ 200 M 2012 $ 354 M 2013 $ 512 M 2014 $ 266 M Millions