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Prospettive della Ricerca Clinica in Italia Catania, 9 Marzo 2005 Prospettive della Ricerca Clinica in Italia Angela Capriati, Corporate Clinical Research-

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Presentation on theme: "Prospettive della Ricerca Clinica in Italia Catania, 9 Marzo 2005 Prospettive della Ricerca Clinica in Italia Angela Capriati, Corporate Clinical Research-"— Presentation transcript:

1 Prospettive della Ricerca Clinica in Italia Catania, 9 Marzo 2005 Prospettive della Ricerca Clinica in Italia Angela Capriati, Corporate Clinical Research- Menarini Group

2 I tempi dello sviluppo clinico registrativo impongono di definire oggi le strategie che condizioneranno le prospettive a medio-lungo termine della ricerca clinica

3 Le prospettive della ricerca clinica italiana dipendono strettamente dalla qualità ed investimenti in ricerca

4 Research and Development of a new Drug DISCOVERY PRECLINICAL CLINICAL REGULATORY MARKETING DEVELOPMENT DEVELOPMENT SUBMISSION AUTHORIZ. Florence, Pomezia Pomezia, Berlin, Pisa, Lomagna Florence, Berlin, Barcelona Molecol. Biol Drug Design Chemistry Pharmacology Kinetics & Metabolism Toxicology Chemical Development Galenics Biotechnological Development Phase I Phase II Phase III

5 Berlin Barcelona Rome Florence Pisa Menarini R&D Sites 11 employees in year 1978 736 employees in year 2003 Milano

6 Clinical Research Mission INNOVATIVITA INTERNAZIONALIZZAZIONE

7 Internazionalizzazione La ricerca clinica in Italia è di fatto una ricerca clinica in Europa

8 Barcelona Florence Berlin Menarini Clinical Research

9 Nazionali, EMEA, FDA La ricerca clinica italiana deve mirare ad uno sviluppo clinico non solo europeo ma mondiale Scientific Advice Advisory Board Accademici Normative EU, ICH guidelines

10 Medical and Social Need Risk benefit ratio SELEZIONE Aree terapeutiche Prodotti Innovatività

11 INNOVATIVITA Nuovi prodotti e nuove strategie terapeutiche Nuove indicazioni Nuove popolazioni target

12 1. Nuovi prodotti e nuove strategie terapeutiche

13 MEN 2234 Project Status: Clinical Phase III Therapeutic vaccine: it acts as a murine monoclonal anti-idiotype antibody mimicking the structure of CA 125, the Tumor Associated Antigen (TAA) over-expressed on epithelial ovarian cancer

14 Phase I-II Results : Immunization induced by MEN 2234 toward ovarian TAA favours survival in 3rd line therapy of ovarian cancer MEN 2234 Survival Benefit

15 Debulking Surgery Chemotherapy Progressive disease Second Line Therapy Tumor Response or Stabilisation Watch-full Waiting Period Progressive disease + Manteinance of Response Epithelial Ovarian Cancer Medical Need (85%)

16 Total number of patients to be randomised: 1164 (n=582 per arm) 2 year recruitment + 2 year min follow up >150 Investigational Sites to be activated in EU and USA MEN 2234 Phase III study

17 2. Nuove indicazioni

18 potential better risk/benefit ratio than conventional anthracyclines SABARUBICIN Preclinical Evidence broader antitumoral activity favourable pharmacokinetics lower cardiotoxicity potential

19 rare disease (year prevalence < 5 cases / 10,000) first line chemotherapy used always as combination regimens (EP, CAV, CEV) 1 with limited impact on survival but significant toxicity very poor prognosis (median survival <12 months despite of its high chemosensitivity) High medical need for new chemotherapy with improved efficacy and/or improved safety 1 EP= etoposide-cisplatin; CAV/CEV=Cyclophosphamide+adriamicine/epirubicine+vincristine Sabarubicin Small Cell Lung Cancer

20 Sabarubicin Phase II Clinical evidence Most promising antitumoral activity (response rate, survival) as single agent in phase II clinical trial recruiting patients with SCLC-ED; Incidence and severity of toxicity (including class- related myelotoxicity and cardiotoxicity) in the overall six phase II studies lower than expected for anthracyclines.

21 Sabarubicin Orphan Medicinal Product Designation According to Regulation (EC) No 141/2000 of the European Parliament and of the Council of the European Union the designation of orphan medicinal product for the indication of SCLC was sought as treatment of a disease affecting not more than 5 in 10,000 persons in the Community [Art. 3 (1) (a)] and as a medicinal product which will be of significant benefit to those affected by that condition [Art. 3 (1) (b)]

22 Sabarubicin Orphan Medicinal Product Designation

23 3. Nuove popolazioni target

24 Study of Effects of Nebivolol Intervention on Outcomes and Rehospitalisation in Seniors with Heart Failure SENIORS

25 61 2647 BisoprololCIBIS-II 643991 Metoprolol CR/XLMERIT-HF 581094 CarvedilolUS Carvedilol 61 Mean 632289 CarvedilolCOPERNICUS 60 2708 BucindololBEST Mean ageN ß-blockerTrial Age and Sex of Patients in Major Placebo- Controlled Trials of ß-Blockers in CHF % Males 77 78 80 78 79 SENIORS

26 Prevalence of Congestive Heart Failure by Age and Sex in NHANES Source:CDC/NCHS. 0 1 2 3 4 5 6 7 8 91020-2425-3435-4445-5455-6465-74>74 MenWomen Percentage (%) Study population in BB trials SENIORS

27 27.52647BisoprololCIBIS-II 28.03991Metoprolol CR/XLMERIT-HF 22.6 1094 Carvedilol US Carvedilol 24.9Mean 19.82289CarvedilolCOPERNICUS 23.02708BucindololBEST EF%Nß-blockerTrial Ejection Fraction (%) of Patients in Major Placebo- Controlled Trials of ß-Blockers in CHF SENIORS

28 Age >70 years A clinical diagnosis of chronic heart failure (HF) and either of: a) documented LVEF < 35% within previous 6 months or b) hospital admission within previous 1 year for congestive HF Written consent prior to enrolment into the study SENIORS Inclusion Criteria

29 Study Protocol SENIORS

30 0 25 50 75 100 125 150 175 200 225 Age (years) Number of patients 707580859095 Median age = 75.2 years SENIORS Baseline Characteristics - Age

31 0 100 200 300 400 500 600 10 - 1415 - 1920 - 2425 - 2930 - 3435 - 3940 - 4445 - 4950 - 5455 - 5960 - 6465 - 6970 - 7475 - 80 Left ventricular ejection fraction (%) Number of patients LVEF < 35%: mean value = 28.7%LVEF > 35%: mean value = 49.2% Baseline characteristics - LVEFSENIORS

32 0.400.500.600.700.800.901.001.101.20 Hazard ratio and 95% CI Benefit of Nebivolol vs other beta-blockers Favours Nebivolol Favours Placebo Primary outcome SENIORS- Overall population - Age < 75 y & LVEF < 35% All cause mortality SENIORS - Overall population - Age < 75 y & LVEF < 35% CIBIS II MERIT COPERNICUS SENIORS

33 Fast Track SENIORS

34 > 25.000 Expected Patients in Clinical Trials in 2006 0 4000 8000 12000 16000 20000 24000 1992199520002006


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