June, 2006 Clinical Studies – Geographic Distribution • In the world: + 15.000 clinical studies in progress – Applied Clinical Trials, April 2003 • Number of global studies increased 11.7% from March 2004 to March 2005 - Applied Clinical Trials, June 2006 Clinical Studies in U.S.A. • 32.240 clinical studies are listed in the ClinicalTrials.gov • 20.463 clinical studies in U.S.A. are, at this moment, in planning or in opening phase • 9.594 clinical studies in U.S.A. are, at this moment, enrolling patients • 491clinical studies in South America are enrolling patients ClinicalTrials.gov 16 August 2006 Increasing Demand • More than 600 new drugs for treatment of cancer are in development this year. • More than 650 clinical studies are in progress for breast, lung and prostate cancer • 238.000 patients are necessary to complete those studies Clinical Trials for Cancer Running Out of Volunteers, CenterWatch, July 2006 ANVISA Special communication (CEs) 767 1000 900 767 800 846 880 819 881 940 394 430 700 600 500 180 394 400 30 300 200 30 100 430 80 180 80 0 1 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 ! " # ! " # $% & ( + # $ ' && ) * + ( ' & , - (./ & ) 0 & ! " (. 1 ! " 32 - ( & " + ) * + 0 (0 .6 ) 02 - "! 2 ! 41 , + ( , 1 0 0 + ! & + ( 1 8 + )0 0 ) 0 • • • • ( +"' 51 ! " 0 / & 71 ! + , " & & ( . . & 1 0 + 0$ 8 8 ! ! 6 . ) ( "´ ( ) ! "9 ' 1. Central feasibility and enrollment projections 2. Central study initiation services 3. Contracts and proposals 4. Regulatory documents 5. Drug importation and distribution 6. Harmonized IBPC SOPs and training (SOP and protocolspecific) 7. Common technology platform and study management systems 8. Patient data base ! "9! ( ) * % & 1 ! ": ! , 51 ! ": , + 1 " % + 1 ' 1 # (& 51 71 1 & ;++ (1 ' && ( " ! ' ( 1 ' • " • ! ( & + • & ! 8 ' ;' ( • - ( ( • 8 ) * " ( , 0 ! 1 1 <=81 & . ' ( ,.' ! ' + ) 0 0 1 & 1 -' ' )$ - (." PRIMARY LOCATION Estimated New Cases per year NEOPLASIAS Male Female Total - 48,930 48,930 Lung 17,850 9,320 27,170 Stomach 14,970 8,230 23,200 - 19,260 19,260 Prostate 47,280 - 47,280 Colorectal 11,390 13,970 25,360 Esophagus 7,970 2,610 10,580 Leukemia 5,330 4,220 9,550 Oral Cavity 10,060 3,410 13,470 Melanoma 2,710 3,050 5,760 Other Locations 61,530 63,320 124,850 179,090 176,320 355,410 55,480 61,160 116,640 234,570 237,480 472,050 Breast Cervix Subtotal Skin ALL NEOPLASIAS $! > "? –" ; 3. 5 4@ 0 &$ )))1 1( '1, A ! 1 51 "9- - & & $# ' & , 0 . +/ & 09B )0 / 0! ! 3. ") & 5 4@ 0 &$ & 1 1 1( ' , A ! " & ( "!%!; !%; !> %!%C%!-> > / E " ( 8 " - / ' & D 8 ! ( ( & 7 - C ' / / & ( E & D " ( & 8 ( # & / # , " I / ( ( F " / - H I ; # /" C ! G , 8 ( D " 8 / & / & & J " # 8 " ' 0 " 5 , ! K! " ": ' 0 , ( & 8 ( & &0 G ( ! "9 & # + 3 ' / ,4 Multicentric Phase III 13 Phase II 8 Phase I/II 2 Phase II/III 1 Phase IV 3 Multicentric Phase III 3 Phase II 2 Phase IV 3 Multicentric Phase III 7 Phase II/III 1 Phase I 1 * 3E % 3 4 ) / 4 ! "9; . & + !: "J , * $ C ' # $ # - # 8 & E !>"8 9 ! (. " " 9 > "? + $ - ( " 8 & .+ * $ $ # " # C ' (. / + 8 # C ' / . + (. - - # (. & ( 0 + .' ! .' (.9 C 8 $ - ( " 8 (. - E " "M ( . +" ; # L . +" "M ( - (. # ! " 0 & : ' Gastrointestinal and Other malignances Incidence of new cases by site in 2005 CID-1O 2nd. editionCity New cancer cases per site by topography Total Salvador Fortaleza BH1 BH2 P. Alegre Ja 1 1 1 1 1 1 C15Esophagus C16Stomach C18Colon C20Rectum C22Hepatocarcinoma C25Pancreas C28Anal Canal 8 70 245 40 55 140 1 23 13 18 34 2 1 15 225 156 145 121 108 64 49 59 8 9 15 190 131 112 92 108 260 174 98 13 57 4 Other malignances C34Bronchial tubes and Lungs C43Melanoma C44Skin C50Breast C53Cervix C56Ovary C61Prostate 139 22 30 417 32 69 317 159 105 75 24 139 226 57 # of Sites S‹o Paulo Piracicaba Limeira 1 1 1 9 6 24 42 24 2 8 4 8 8 36 24 872 2,592 5,226 1,593 392 408 287 86 10 44 142 18 28 106 12 182 30 6 88 GI malignances 564 302 25 131 27 14 908 217 62 115 83 481 93 40 166 20 12 196 1,866 4,405 1,101 312 140 220 270 6 2 822 1,124 5,344 504 6,070 102 342 210 21 58 732 1,525 612 836 1,104 1,030 1,293 14,612 1,346 1,041 3,896 - ( ( +! " ! ! E 8 ' " . > 3 ! + " 0 > ) * 4 0B ";- <=8 !% && " -++ ! 0 B ( & , - ( ( +! " - & - ! ! E 8 ' % " . > 3 ! + " 0 > ) * 4 0B ";- <=8 !% && " -++ ! 0 B ( & , ! "9 0 / ++ 0 D ( D / 8 + " I " , N# , ( 0 / ' 0 " & / & / & D D "1 D "; -> ;. 8 N" 8 N# " D ( 8 ( 8 ( ( ? ( / / / # / 8 > ( 8 E H& C>!E; 9/ & I I C>!E; 9/ & I I ! 8 9/ J & / ! " "M " 0 E C" - E#C # N & ( 8 ( E " * - " E % ( , C ' #E I - >' ( ! I D / / * F " # > D, ! DE , M " D ( - & , & ( F 8 " ' 0 I I " & ' ' 0 G ! " 1 ! 8 ' "0 • $ 0B B 51 # • + , / #!% $ 0B + 0. #!% > , 0& 0 ( #1B1 D E + • # • " • / • ";- 1 ! 71 . * 0 + + ";- + " 0 , + 0 0 - ( / & í D, F ! " 9 <8 - 1 • • # D' 51 - ( • • 71 1 1 ' .+ ++ ' ( , & ' ) + & 0 ( ! ' & & 0# ( ) 0 & ( + (+ & - & EB8 >"! ! "9 ( . , 1 8 0 ' 51 %) 1 & ) & ' 51 71 " 1 # 1 ; ! + + (! 7 + 0 +& & ,. . ' ) && ' 4 . ) , 0. ' ) 3+ + + ,."->; 8>J! 8 ( ( )0 ' . ! " B ( 1 " , , 51 % 71 ) 0 + 5& ( + • + ' 1 B ' 1 8>J! 8 . + (& (. 1 ( • + $ 3 1 -& , & ' 8( ( 5 , O0 6 .4 + 1 . 1 (. + +! "" , 1. Accelerated study initiation and enrollment 2. Consistent research excellence, quality and compliance (international standards; pivotal programs) 3. Sponsor performance and accountability 4. Patient and site management time and expense savings 5. Real time information and communication 6. Comprehensive and cost effective Latin American CRO services 7. Contribution to national and international oncology research capacity, expertise and patient care June, 2006