The Orphan Drug Act Jeff W. Bailey MS Senior Regional Business Manager Shire Human Genetic Therapies June 2009
Findings: Total Orphan Designations and Approvals 68 79 67 55 60 56 58 65 56 80 89 75 73 59 33 48 41 1 D E S I G N A T E 14 20 20 19 23 11 11 13 13 12 12 12 11 9 6 7 3 2 A P P R O V A L S 00 99 98 97 96 95 94 93 92 91 90 89 88 87 86 85 84 83 Y E A R