La ricerca clinica farmacologica nel paziente anziano: un costo inutile o un dato assente?

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1 La ricerca clinica farmacologica nel paziente anziano: un costo inutile o un dato assente? 57 Congresso Nazionale SIGG Società Italiana di Gerontologia e Geriatria Dr. Marco Scatigna Direttore Medico e Direttore Scientifico Sanofi Italia Direttore Generale Fondazione Sanofi-Aventis

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5 Product Development A Risky and Expensive Proposition 5

6 Ranking by ethical drug sales 1981 Vs HOECHST BAYER MERCK & Co CIBA-GEIGY PFIZER AHP ROCHE SANDOZ LILLY ABBOTT WARNER LAMBERT UPJOHN BRISTOL SQUIBB 2009 PFIZER SANOFI-AVENTIS GLAXO SMITH KLINE NOVARTIS ROCHE ASTRAZENECA MERCK & Co JOHNSON & JOHNSON LILLY BOEHRINGER INGELHEIM ABBOTT BRISTOL-MYERS-SQUIBB TAKEDA BAYER 6

7 $ (in years) External Estimates of COST/NME Year of Estimate Sources: Tufts Center for Drug, Development, Boston Consulting Group, Lehman Brothers 7

8 Mean percentage TRENDS IN BREAKDOWN OF R&D EXPENDITURE BY ACTIVITY FOR MAJOR COMPANIES Discovery Non-clinical Total clinical Regulatory Other Source: IMS Health, Market Prognosis

9 Probability of being launched Attrition data (probability of success) All respondents (=29) Major (n=9) Medium (n=8) Other (n=12) Decision to start preclinical development Start of Phase I Start of Phase II Latest stage reached Start of Phase III Submission of dossier Source: CMR International 9

10 The Patient dilemma 10

11 The randomized controlled clinical trial

12 Historical barriers to the inclusion of elderly subjects in clinical trials Heterogeneity of health status (multiple comorbidities) Polypharmacy Pathophysiologic differences Cognitive function status (compliance, accettable informed consent, greater toxicity*) Logistic N.K.Wenger. Am J, Ger. Card Vol 15, N 6 *M. Markman. Oncology 2007, 72,

13 The imperfection 13

14 Excessive drop out 14

15 Only 22 to 36% of patients 65 years of age or older participate in trials for cancer therapy, even though they represent nearly 60% of the population with cancer Hutchins LF at al. New England Journal of Medicine 1999; 341:

16 Analysis of data from cancer patients in 55 trials between 1995 and 2002 found an enrolment rate of 9% among the over 75s, despite this age group represents 31% of the US cancer population Talarico L, Chen G, Pardur R. Journal of Clinical Oncology 2004;22:

17 Barrier Solution Participation Quality and calibre of the person doing the recruiting Informed consent Simple, short and comprehensive Access Issues Ethnic barriers Provide transportation, engage family members Bicultural approaches, engage family members Subject fear/concern Clear comunication of trials rules Gate keeper Influence Enlisting his cooperation good comunicator Comorbidity and Mortality Sample size adjusted for these different effects stratification 17

18 The HYpertension in the Very Elderly Trial ClinicalTrials.gov: NCT

19 Work Package 1. Literature review Andrew Beswick, Margaret Burke, Yoav Ben Shlomo and Paul Dieppe Medical Research Council Department of Social Medicine, University of Bristol Nuffield Department of Orthopaedic Surgery, University of Oxford November 2008 Increasing the participation of elderly in clinical trials Supported by the European Union, FP7 health research, grant number HEALTH-F

20 The leading pharmaceutical companies are losing between 14% and 41% of their existing revenues as a result of patent expires Company Share of Revenues (%) AstraZeneca Arimidex ($2.2bn)* Seroquel ($4.7bn) Symbicort ($3.7bn) BMS US Plavix ($4.8bn) Abilify ($2.1bn) Avapro ($1.3bn) GSK Advair ($3.8bn)* Avandia ($2.5bn) Eli Lilly Zyprexa ($4.8bn) Merck Cozaar/ ($3.2bn) Singulair ($4.5bn) Hyzaar Novartis Femara ($1.1bn)* Diovan ($6.0bn) Pfizer Aricept ($800m) Lipitor ($12.1bn) Viagra ($4.5bn) Xalatan ($1.6bn) Detrol ($860m) Geodon ($1.1bn) Sanofiaventis Taxotere ($2bn) US Plavix Avapro ($3.8bn) ($2.1bn) US Lovenox ($3.1bn) 38** Source: AXA Framlington 20

21 21

22 FDA Action to increase the number of clinical trials performed in children 1997 Modernization act 2002 BPCA (Best Pharmaceuticals for Children Act) 2003 PRIA (Pediatric Research Improvement Act) 2007 Amendments Act 22

23 As of March 2001, 181 drugs have received pediaric exclusivity under BPCA* pediatric studies have been completed involving patients**. *FDA. Pediatric Esclusivity Granted. March 2011 ** FDA. Breakdown of FDAAA Compleed Pediatric Studies 23

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