PREVIEW Egypt, Israel, Lebanon & Saudi Arabia: Clinical Development Profile [email protected] ©2014 Industry Standard Research www.ISRreports.com act with confidence Report Overview Finding patients to participate in clinical trials is a constant struggle in the pharmaceutical industry. The challenging nature of recruitment leads both sponsors and service providers to consistently explore new geographies to find appropriate patient populations. The largest CROs have made several recent acquisitions and agreements in the Middle East and North Africa region which may indicate that clinical trial activity in the area is poised to increase. In this report, ISR provides insight into the clinical trial regulation and development environment, sponsor and service provider activities, and population “health status” for Egypt, Israel, Lebanon, and Saudi Arabia. Consider this report a “primer” for learning about clinical trials in the region. Methodologies: ISR gathered content for this report via an exhaustive secondary research effort and from company profile questionnaires that were distributed to CROs profiled in this report. 46 Report Structure: Charts and Graphs 1. Introduction 2. Health Statistics Q3, 2014 3. Clinical Trial Overview and Trial Metrics Publication Date 4. Domestic CROs capabilities 62 5. Profile of Domestic Clinical Service Providers Pages 6. Domestic Service Provider Contact List What you will learn in this report: • How population health status, regulations, organizations on conducting clinical trials clinical trial activity, and international and in Egypt, Israel, Lebanon and Saudi Arabia domestic company partnerships make Egypt, • Clinical trial operational metrics for country- Israel, Lebanon, and Saudi Arabia some of the specific clinical studies top emerging global pharmaceutical markets • Compiled lists and contact details for domestic • Insights from domestic service provider and international service providers How you can use this report: • Understand how Egypt, Israel, Lebanon, and • Understand the legal, logistical, and regulatory Saudi Arabi compare to other countries on details for conducting clinicals trials, and a variety of health condition scales so the illustrate the benefits and drawbacks of reader can consider the areas in which they conducting trials in Egypt, Israel, Lebanon, and may be beneficial as trial sites Saudi Arabia NEXT: Table of contents and sample pages www.ISRreports.com ©2014 | Preview of: Egypt, Israel, Lebanon & Saudi Arabia: Clinical Development Profile 2 act with confidence Table of Contents Copyright and Usage Guidelines Company profile responses Methodology and Sources Geographic reach Introduction Therapeutic expertise Egypt Experience by Phase Israel Triumpharma Lebanon Background / History Saudi Arabia IPRC Health Statistics Background / History Clinical Trial Activity Acdima BioCenter Egypt Background / History Clinical trials, by Phase Pharmaceutical Research Unit Study type distribution Background / History Industry-funded study type distribution Molecule CRO Average trial length, by Phase Background / History Average enrollment, by Phase MEK Consulting Israel Background / History Clinical trials, by Phase Therapeutic experience Study type distribution Therapeutic experience by Phase Industry-funded study type distribution Regional experience Average trial length, by Phase Organizational structure Average enrollment, by Phase Clients and studies Lebanon CRA education Clinical trials, by Phase CRA experience Study type distribution ClinServ Industry-funded study type distribution Background / History Average trial length, by Phase Nagy Research Average enrollment, by Phase Background / History Saudi Arabia Examples of clients Clinical trials, by Phase SCIDRE Co. Study type distribution (i.e. interventional) Background / History Industry-funded study type distribution Clinart MENA Average trial length, by Phase Background / History Average enrollment, by Phase Company progress Domestic CROs capabilities chart Interventional studies Domestic Clinical Service Providers Observational studies Atlas Medical Services Domestic Service Provider Contact List Background / History About Industry Standard Research Jordan Center for Pharmaceutical Research Background / History MCT Background / History www.ISRreports.com ©2014 | Preview of: Egypt, Israel, Lebanon & Saudi Arabia: Clinical Development Profile 3 act with confidence Sample Page Introduction act with confidence Introduction Finding patients to participate in clinical trials is a constant struggle in the pharmaceutical industry� The challenging nature of recruitment leads both sponsors and service providers to consistently explore new geographies to find appropriate patient populations� The largest CROs have made several recent acquisitions and agreements in the Middle East and North Africa region which may indicate that clinical trial activity in the area is poised to increase� • PAREXEL acquired Istanbul-based service provider Atlas Medical Services in July 2014 with the goal of serving clients who see increasing importance in the region and who are seeking broad range of patient populations and market access� • In March 2014, INC Research expanded its presence in the region by purchasing MEK Consulting, a clinical-monitoring focused CRO based in Lebanon� • Quintiles formed an agreement in February 2012 with Dayarn Pharma, a company specializing in pharmaceutical sales, marketing, regulatory services� The partnership allowed Quintiles and its partners to supply contract sales forces and sales promotion outsourcing services in the region� Quintiles cited growing healthcare spend and demand for services in the region as the primary reasons for forming the partnership� Industry Standard Research has compiled secondary research and statistics in this new report Egypt, Israel, Lebanon & Saudi Arabia: Clinical Development Profile to provide readers with a primer on clinical trial activity in the aforementioned countries� A high-level overview of current clinical trial figures is provided below: TrialsTrials conductedconducted TrialsTrials conductedconducted TrialsTrials conductedconducted TrialsTrials conductedconducted only in only in only in onlyonly inin only in only in only in EgyptEgypt IsraelIsrael LebanonLebanon SaudiSaudi ArabiaArabia # of Ongoing TrialsTrials 8585 1,2191,219 1313 6969 # of Ongoing Trials by Phase Phase 0: 4 Phase 0: 7 Phase 0: 0 Phase 0: 2 Phase I: 3 Phase I: 47 Phase I: 0 Phase I: 2 # of Ongoing Industry- Data available in full report Phase II: 13 Phase II: 168 Phase II: 2 Phase II: 11 # of OngoingFunded Trials Trials by Phase Phase III: 16 Phase III: 83 Phase III: 2 Phase III: 12 # of Patients Currently Phase IV: 13 Phase IV: 92 Phase IV: 4 Phase IV: 4 Enrolled in Trials No Phase: 36 No Phase: 822 No Phase: 5 No Phase: 38 # of Ongoing Industry- 9 150 2 1 Funded Trials # of Patients Currently ~30,000 ~208,000 ~1,900 ~16,000 Enrolled in Trials © Industry Standard Research www.ISRreports.com ©2014 | Egypt, Israel, Lebanon & Saudi Arabia: Clinical Development Profile 7 www.ISRreports.com ©2014 | Preview of: Egypt, Israel, Lebanon & Saudi Arabia: Clinical Development Profile 4 act with confidence Sample Page Clinical Trial Activity act with confidence Egypt Clinical trials, by Phase Percentages are based on the number of ongoing and recently completed (past two years) trials conducted only in Egypt (N=203)� How to read the table: 3 (4%) of the 85 ongoing trials conducted only in Egypt are Phase I trials� Egypt Ongoing Recently Total Completed Trials (past two years) Total 85 118 203 Phase 0 4 (5%) 3 (3%) 7 (3%) Phase I 3 (4%) 5 (4%) 8 (4%) Phase II 13 (15%) 20 (17%) 33 (16%) Phase III 16 (19%) 26 (22%) 42 (21%) Phase IV 13 (15%) 14 (12%) 27 (13%) No Phase 36 (42%) 50 (42%) 86 (42%) © Industry Standard Research Study type distribution The table represents the number of ongoing and recently completed (past two years) trials conducted only in Egypt by the type of study type listed in ClinicalTrials�gov� How to read the table: 70 (82%) of the 85 ongoing trials are classified in ClinicalTrials�gov as “interventional” trials� Egypt Ongoing Recently Total Completed Trials (past two years) Total 85 118 203 Interventional 70 (82%) 92 (78%) 162 (80%) Observational 15 (18%) 26 (22%) 41 (20%) Expanded Access - - - © Industry Standard Research www.ISRreports.com ©2014 | Egypt, Israel, Lebanon & Saudi Arabia: Clinical Development Profile 19 www.ISRreports.com ©2014 | Preview of: Egypt, Israel, Lebanon & Saudi Arabia: Clinical Development Profile 5 act with confidence Sample Page Domestic CROs capabilities act with confidence Domestic CROs capabilities Atlas Medical Atlas Pharmac Research for Center Jordan PharmaquestJo Pharma Poseidon MCT Triumpharma IPRC BioCenter Acdima Unit Research Pharmaceutical CRO Molecule MEK Consulting ClinServ Ergomed Research Nagy Scidreco Clinart MENA Atlas Medical Atlas Research Pharmac for Center Jordan PharmaquestJo Poseidon Pharma MCT Triumpharma IPRC Acdima BioCenter Unit Pharmaceutical Research Molecule CRO MEK Consulting ClinServ Ergomed Nagy Research Scidreco Clinart MENA RegionRegion AustraliaAustralia MENAMENA EuropeEurope N.N �Americas Americas RestRest of of Asia Asia JapanJapan RussiaRussia S.S �America America WorldwideWorldwide PhasePhase PreclinicalPreclinical PhasePhase I I PhasePhase II II Phase III Data available in full report Phase III Phase IV Phase IV Post launch Post launch No mention No mention Services Bio Analysis Services Bio Analysis Biostatistics Biostatistics