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Current Bills on U.S. Capitol Hill Waxman Schumer Kennedy Eschoo HR1427 S.726 HR1548 Data Exclusivity: 5 years 12 years New Indication Extension: 6 months.

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Presentation on theme: "Current Bills on U.S. Capitol Hill Waxman Schumer Kennedy Eschoo HR1427 S.726 HR1548 Data Exclusivity: 5 years 12 years New Indication Extension: 6 months."— Presentation transcript:

1 Current Bills on U.S. Capitol Hill Waxman Schumer Kennedy Eschoo HR1427 S.726 HR1548 Data Exclusivity: 5 years 12 years New Indication Extension: 6 months 2 years Similarity Standard: no clinically meaningful differences high degree of similarity/per indication Clinical Studies: FDA discretion1+ clinical studies/HHS secretary can waive Guidance Documents: FDA discretion required Patent Notification: applicant can request patent info challenges OK 3 years before expiration no link between approval & litigation no approval before patent expiry/invalidity Naming:same as innovator unique name Interchangeability:FDA to determine only if HHS secretary has issued guidance Exclusivity for 1 st product: 6 months 2 years Pediatric Exclusivity Extension: 6 months 6 months

2 ProductBrandApprovedUS ExpiryPatent Protection (Years) 2008 Sales ($B) InfliximabRemicade8/24/19982018206.5 RituximabRituxan11/26/19972018215.6 TrastuzumabHerceptin9/25/19982016184.8 BevacizumabAvastin2/26/20042018144.7 AdalimumabHumira12/31/20022017154.4 EtanerceptEnbrel11/2/19982014163.6 CetuximabErbitux2/12/20042019152.0 PalivizumabSynagis6/19/19982015171.2 OmalizumabXolair6/20/20032014110.85 NatalizumabTysabri11/23/2004??0.6 AlemtuzumabCampath5/7/20012015140.12 US Patent Expiry vs. Data Exclusivity Most marketed MAbs have patent coverage beyond even longest contemplated data exclusivity period

3 6 5 4 3 2 1 0 -2 5x Return 3x Return Breakeven Development Cost Erbitux – Payback Curve ($700M Cost Model) 2004 2005 2006 2007 2008 2009 2010 2011 2012 Revenues COGS + SG&A Profit (before tax) Cumulative Profit (before tax) $Billion 1 2 3 4 5 6 7 8 9

4 6 5 4 3 2 1 0 -2 5x Return 3x Return Breakeven Development Cost Erbitux – Payback Curve ($1.2B Cost Model) 2004 2005 2006 2007 2008 2009 2010 2011 2012 Revenues COGS + SG&A Profit (before tax) Cumulative Profit (before tax) $Billion 1 2 3 4 5 6 7 8 9

5 6 5 4 3 2 1 0 -2 5x Return 3x Return Breakeven Development Cost 2004 2005 2006 2007 2008 2009 2010 2011 2012 Revenues COGS + SG&A Profit (before tax) Cumulative Profit (before tax) $Billion 1 2 3 4 5 6 7 8 9 Xolair – Payback Curve ($700M Cost Model)

6 6 5 4 3 2 1 0 -2 5x Return 3x Return Breakeven Development Cost 2004 2005 2006 2007 2008 2009 2010 2011 2012 Revenues COGS + SG&A Profit (before tax) Cumulative Profit (before tax) $Billion 1 2 3 4 5 6 7 8 9 Xolair – Payback Curve ($1.2B Cost Model)


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