Gleaning_Competitive.. - Pharma CI Conference

Gleaning competitiveinsights from clinicaltrial informationPharma CI ConferenceSeptember 13-14, 2011

Prudent Strategic Analysis• Prudent strategic analysis requires a comprehensive view of thecompetitive landscapeAssess the Past• Analysis of published resultsAssess the Present• Analysis of conference abstractsAssess the Future• Analysis of ongoing clinical trialsWolters Kluwer ConfidentialSeptember 19, 2011 - USA 2

Public InformationThe Good News …• Publicly available information can provide a wealth of competitive intelligence.The Problem …• How to collect, assess and analyze all of the available clinical trial knowledge tomake an informed strategic decision?Wolters Kluwer Confidential September 19, 2011 - USA 3

Uses of Trial Information• Monitor competitor progress through clinical development• Measure a drugs strengths and weaknesses against another• Uncover key study messages and claims being presented by competitors• Assess publication strategies competitors are pursuing• Determine the evidence needed for brand protection• Assist in planning for the optimal Target Product Profile• Evaluate the clinical evidence for a particular MOA/drug for BDassessments• Discover life-cycle opportunities for productsSeptember 19, 2011 - USA 4

Who are my future competitors?RHEUMATOID ARTHRITIS CASE STUDYSeptember 19, 2011 - USA 5

Rheumatoid Arthritis Case StudyWho are my future competitors?• Locate all clinical trials studying RA posted on clinical trial registries• Read all the trials details for each RA trial• De-duplicate the list of trials• Identify how many trials each company is conductingWolters Kluwer ConfidentialSeptember 19, 2011 - USA 6

Rheumatoid Arthritis Case StudyWho are my future competitors?• 110 companies are currently studying drugs for RAAdisInsight Clinical Trials Insight VisualizationWolters Kluwer ConfidentialSeptember 19, 2011 - USA 7

Rheumatoid Arthritis Case StudyWho are my future competitors?• Top 20 : How many trials do future competitors have in clinical development?AdisInsight Clinical Trials Insight VisualizationWolters Kluwer ConfidentialSeptember 19, 2011 - USA 8

How are future competitors progressing through clinical development?RHEUMATOID ARTHRITIS CASE STUDYSeptember 19, 2011 - USA 9

Rheumatoid Arthritis Case StudyHow are future competitors progressing through clinical development?• Search all clinical trial registries to locate all the drugs being studied• Read and analyze each study• De-duplicate• Remove all trials that are not in Phase I, II, or III• Remove those trials that are completed or discontinued• Break these trials out by phase of development• Determine the current status for all ongoing trials• Determine time until completion for each trialWolters Kluwer ConfidentialSeptember 19, 2011 - USA 10

Rheumatoid Arthritis Case StudyHow are future competitors progressing through clinical development?• Over 200 drugs currently being studied in 383 clinical trials in RA (phase I, II, III)AdisInsight Clinical Trials Insight VisualizationWolters Kluwer ConfidentialSeptember 19, 2011 - USA 11

Rheumatoid Arthritis Case StudyHow are future competitors progressing through clinical development?• Broken out by Top-25 drugsAdisInsight Clinical Trials Insight VisualizationWolters Kluwer ConfidentialSeptember 19, 2011 - USA 12

Rheumatoid Arthritis Case StudyHow are future competitors progressing through clinical development?• What phase of development is Tofacitinib being studied in RA?AdisInsight Clinical Trials Insight VisualizationWolters Kluwer ConfidentialSeptember 19, 2011 - USA 13

Rheumatoid Arthritis Case StudyHow are future competitors progressing through clinical development?• What is the current status of Tofacitinib studies in RA?AdisInsight Clinical Trials Insight VisualizationWolters Kluwer ConfidentialSeptember 19, 2011 - USA 14

Rheumatoid Arthritis Case StudyHow are future competitors progressing through clinical development?• How soon will Tofacitinib complete current studies in RA?AdisInsight Clinical Trials Insight VisualizationWolters Kluwer ConfidentialSeptember 19, 2011 - USA 15

Rheumatoid Arthritis Case StudyHow are future competitors progressing through clinical development?• Trial status chart for Tofacitinib in RAAdis Clinical Trials Database: Trial Profiles - Status TrackingDrug(s) Study Phase Adis CTI Trial Record Study Status End DateTofacitinib Pfizer IIIIII700048545 Completed 01 Jan 2010 (actual)700057019 Completed 01 Aug 2010 (actual)700058869 Completed 01 Sep 2010 (actual)700058870 Completed 01 Aug 2010 (actual)700051532 Completed 01 Mar 2010 (actual)700193655 Completed 01 Mar 2011 (actual)700058888 Completed 01 Sep 2010 (actual)700196350 Recruiting 01 Feb 2012 (planned)700055398 Active, no longer recruiting 01 Oct 2010 (planned)700034705 Completed 01 Jul 2010 (actual)700012007 Completed700020671 Active, no longer recruiting 01 Feb 2012 (planned)700042414 Completed 05 Mar 2011 (actual)700040242 Completed 01 Jun 2010 (actual)700048110 Completed 06 Apr 2011 (actual)700033479 Recruiting 01 Dec 2013 (planned)700041878 Recruiting 01 Feb 2012 (planned)Wolters Kluwer ConfidentialSeptember 19, 2011 - USA 16

What are competitors studying in clinical development?RHEUMATOID ARTHRITIS CASE STUDYSeptember 19, 2011 - USA 17

Rheumatoid Arthritis Case StudyWhat are competitors studying in clinical development?• 39 endpoints are being studied for RAAdisInsight Clinical Trials Insight VisualizationWolters Kluwer ConfidentialSeptember 19, 2011 - USA 19

Rheumatoid Arthritis Case StudyWhat are competitors studying in clinical development?• 20 mechanisms of action are being studied for RAAdisInsight Clinical Trials Insight VisualizationWolters Kluwer ConfidentialSeptember 19, 2011 - USA 20

Rheumatoid Arthritis Case StudyWhat are competitors studying in clinical development?• Cell Modulators: Endpoints being studied for RAAdisInsight Clinical Trials Insight VisualizationWolters Kluwer ConfidentialSeptember 19, 2011 - USA 21

Where is clinical development taking place?RHEUMATOID ARTHRITIS CASE STUDYSeptember 19, 2011 - USA 22

Rheumatoid Arthritis Case StudyWhere is clinical development taking place?• Identify all the clinical trials for RA posted on clinical trial registries• Read and analyze each study• De-duplicate• Remove all trials that are not in Phase I, II, or III• Remove those trials that are completed or discontinued• Identify where the studies are being conductedWolters Kluwer ConfidentialSeptember 19, 2011 - USA 23

Rheumatoid Arthritis Case StudyWhere is clinical development taking place?• Phase I, II, and III clinical trials in RA are taking place in 89 countriesAdisInsight Clinical Trials Insight VisualizationWolters Kluwer ConfidentialSeptember 19, 2011 - USA 24

Rheumatoid Arthritis Case StudyWhere is clinical development taking place?• Broken out by Top-50 countriesAdisInsight Clinical Trials Insight VisualizationWolters Kluwer ConfidentialSeptember 19, 2011 - USA 25

What key study messages and claims are being presented by competitors?RHEUMATOID ARTHRITIS CASE STUDYSeptember 19, 2011 - USA 26

Rheumatoid Arthritis Case StudyWhat key study messages and claims are being presented by competitors?• Collect all RA trial results presented at major conferences• Scan each trial results• Identify which trial results are significant• Read and analyze the significant trial results• Break out trial results by drug• Identify key efficacy, tolerability, pharmacoeconomic, and other claims• Identify messages for combination therapiesWolters Kluwer ConfidentialSeptember 19, 2011 - USA 27

Rheumatoid Arthritis Case StudyWhat key study messages and claims are being presented by competitors?• Claims for Tofacitinib in RAAdis Clinical Trials Database: Trials Results - ConferencesMeeting NameStudy NameStudyPhaseEfficacyClaimsTolerabilityClaimsPECClaimsCombinationClaims2011 Annual Congress of the European League Against Rheumatism ORAL-Solo III x2011 Annual Congress of the European League Against Rheumatism II x x2011 Annual Congress of the European League Against Rheumatism ORAL Sync III x x2011 Annual Congress of the European League Against Rheumatism ORAL-Solo III x x2010 Annual Scientific Meeting of the American College of Rheumatology ORAL-Sequel II/III x x2010 Annual Scientific Meeting of the American College of Rheumatology ORAL-Sequel II/III x x2010 Annual Scientific Meeting of the American College of Rheumatology ORAL-Solo III x x2009 Annual Scientific Meeting of the American College of Rheumatology II x2009 Annual Scientific Meeting of the American College of Rheumatology II x2009 Annual Scientific Meeting of the American College of Rheumatology II x x2009 Annual Scientific Meeting of the American College of Rheumatology II x x x2009 Annual Congress of the European League Against Rheumatism II x2009 Annual Congress of the European League Against Rheumatism II x2009 Annual Congress of the European League Against Rheumatism II x x2009 Annual Congress of the European League Against Rheumatism II x x x2008 Annual Scientific Meeting of the American College of Rheumatology II x2007 Annual European Congress of Rheumatology II x2007 Annual European Congress of Rheumatology II x2006 Annual Scientific Meeting of the American College of Rheumatology II x xWolters Kluwer ConfidentialSeptember 19, 2011 - USA 28

Rheumatoid Arthritis Case StudyWhat key study messages and claims are being presented by competitors?• Efficacy messages for Tofacitinib in RAAdis Clinical Trials Database: Trials Results - Efficacy MessagesMeeting Name Study Name Study Phase Treatment Details Efficacy Study Messages2011 Annual Congress of the EuropeanLeague Against Rheumatism2011 Annual Congress of the EuropeanLeague Against Rheumatism2011 Annual Congress of the EuropeanLeague Against Rheumatism2010 Annual Scientific Meeting of theAmerican College of RheumatologyORAL-Solo III 10mg/day and 20mg/day Monotherapy more effective than placebo on ACR 20 at 3 months regardless ofserological (rheumatoid factor or anti-cyclic citrullinated peptide) status, age, weight andsexORAL Sync III 10mg/day and 20mg/day More effective on ACR 20 than placebo in patients on background disease-modifyingantirheumatic drugs. Health assessment questionnaire scores decreased to a greaterextent from baseline.ORAL-Solo III 10mg/day and 20mg/day Significant improvement over placebo (Visual Visual Analogue Scale pain scores;p

Rheumatoid Arthritis Case StudyWhat key study messages and claims are being presented by competitors?• Tolerability messages for Tofacitinib in RAAdis Clinical Trials Database: Trials Results - Tolerability MessagesMeeting Name Study Name Study Phase Treatment Details Tolerability Study Messages2011 Annual Congress of the EuropeanLeague Against Rheumatism2010 Annual Scientific Meeting of theAmerican College of Rheumatology2010 Annual Scientific Meeting of theAmerican College of Rheumatology2010 Annual Scientific Meeting of theAmerican College of Rheumatology2009 Annual Scientific Meeting of theAmerican College of Rheumatology2009 Annual Congress of the EuropeanLeague Against Rheumatism2006 Annual Scientific Meeting of theAmerican College of RheumatologyORAL Sync III 10mg/day and 20mg/day Associated with infections and infestations in patients with active rheumatoid arthritison background disease-modifying antirheumatic drugs. The majority of adverseevents were mild in severity.ORAL-Sequel II/III 10mg/day and 20mg/day Monotherapy or in combination with methotrexate was generally well tolerated over aperiod of 24 months.ORAL-Sequel II/III 10mg/day and 20mg/day Monotherapy or in combination with methotrexate was generally well tolerated over a24-month period.ORAL-Solo III 10mg/day and 20mg/day Well tolerated with rates of adverse events overall, treatment discontinuations, andserious adverse events similar to placebo. No opportunistic infections occurred.II 10mg/day, 20mg/day, and 30mg/day Acceptable toxicity over 24 weeks with the proportion of patients who experiencedserious adverse events similar to placeboII 6 - 30 mg/day Generally well tolerated in patients with inadequate response to disease-modifyingantirheumatic drugs. Rates of discontinuation due to adverse events were observedII 10 - 60 mg/day Generally well tolerated in patients with active rheumatoid arthritis. The mostcommonly reported adverse events were headache and nausea.Wolters Kluwer ConfidentialSeptember 19, 2011 - USA 30

Rheumatoid Arthritis Case StudyWhat key study messages and claims are being presented by competitors?• Efficacy & Tolerability messages for Tofacitinib combination studiesAdis Clinical Trials Database: Trials Results - Efficacy MessagesMeeting Name Study Name Study Phase Treatment Details Efficacy Study Messages2011 Annual Congress of the EuropeanLeague Against Rheumatism2009 Annual Scientific Meeting of theAmerican College of Rheumatology2009 Annual Congress of the EuropeanLeague Against RheumatismII 20mg/day + Atorvastatin 10mg/day Combination with atorvastatin was somewhat moreeffective than tofacitinib alone (ACR 20% and 50%response rates) at 12 weeksII 5-30mg/day + methotrexate Combination with methotrexate more effective than placeboon ACR20 at 24 weeks. Scores were 59%, 66%, 65%, and54% for CP 5, 10, 15, 20 mg/day respectively versus 35%for placebo.II 2 - 20 mg/day + methotrexate More effective than placebo on ACR20 in Japanese patientstreated with stable, background methotrexate.Adis Clinical Trials Database: Trials Results - Tolerability MessagesMeeting Name Study Name Study Phase Treatment Details Tolerability Study Messages2010 Annual Scientific Meeting of theAmerican College of RheumatologyORAL-Sequel II/III 10mg/day and 20mg/day + methotrexate Monotherapy or in combination with methotrexate wasgenerally well tolerated over a period of 24 months.2010 Annual Scientific Meeting of theAmerican College of RheumatologyORAL-Sequel II/III 10mg/day and 20mg/day + methotrexate Monotherapy or in combination with methotrexate wasgenerally well tolerated over a 24-month period.2009 Annual Scientific Meeting of theAmerican College of RheumatologyII 5-30mg/day + methotrexate Acceptable toxicity over 24 weeks in patients receivingmethotrexate. The most frequently reported events wereurinary tract infections, headache, diarrhoea,nasopharyngitis and nausea.2009 Annual Congress of the EuropeanLeague Against RheumatismII 2 - 20 mg/day + methotrexate Generally well tolerated in Japanese patients receivingstable, background methotrexate. Most treatment-emergentadverse events were mild or moderate in intensity; the mostcommonly observed were nasopharyngitis, stomachdiscomfort and increased levels of liver transaminases andblood cholesterol. Serious adverse events were observedin five patients.Wolters Kluwer ConfidentialSeptember 19, 2011 - USA 31

Rheumatoid Arthritis Case StudyWhat key study messages and claims are being presented by competitors?• PK/PD study messages for Tofacitinib in RAAdis Clinical Trials Database: Trials Results - Other Study MessagesMeeting Name Study Name Study Phase Treatment Details Other Study Messages2011 Annual Congress of the EuropeanLeague Against RheumatismII 20mg/day + Atorvastatin 10mg/day PK/PD: : After switching from tofacitinib monotherapy totofacitinib + atorvastatin, total cholesterol, low densitylipoprotein cholesterol, apolipoprotein B and triglyceridelevels decreased significantly in patients with rheumatoidarthritis.• PharmacoEconomic messages for Tofacitinib in RAAdis Clinical Trials Database: Trials Results - PharmacoEconomic MessagesMeeting Name Study Name Study Phase Treatment Details Economic Study Messages2011 Annual Congress of the EuropeanLeague Against RheumatismORAL-Solo III 10mg/day and 20mg/day Significant improvement in Medical Outcomes Survey ShortForm 36 physical and mental. Significant improvement inFunctional Assessment of Chronic Illness Therapy-Fatiguein patients with inadequate response to at least oneDMARD. 20mg/day showed significant improvement in theMedical Outcomes Survey Sleep Scale in comparison withplacebo.Wolters Kluwer ConfidentialSeptember 19, 2011 - USA 32

Measure product strengths and weaknesses against the competitionRHEUMATOID ARTHRITIS CASE STUDYSeptember 19, 2011 - USA 33

Rheumatoid Arthritis Case StudyMeasure product strengths and weaknesses against the competition• Collect all RA clinical trial results published in the literature• Locate all drug comparison studies• Read and analyze each article and abstract• Identify claimed advantages in efficacy and/or tolerabilityWolters Kluwer ConfidentialSeptember 19, 2011 - USA 34

Rheumatoid Arthritis Case StudyMeasure product strengths and weaknesses against the competition• Drug comparisons studies for Tofacitinib vs Adalimumab (Humira) in RAAdis Clinical Trials Database: Trials Results - Drug Comparisons TrialsDrug(s) Article Title Study Results - Efficacy Study Results - TolerabilityAdalimumab Tofacitinib Results of two phaseIIB studies of the oralJAK inhibitor CP-690,550 and its effectson pain, physicalfunctioning, and healthrelatedquality of life.efficacy: : CP 690550 was effective, and improved quality of life, in patientswith rheumatoid arthritis and an inadequate response to methotrexate.After 12 weeks, pain and Health Assessment Questionnaire scores hadimproved from baseline to a greater extent in recipients of CP 690550 (10,20 and 30 mg/day), but not adalimumab recipients, compared with placebo(all p

Gleaning competitive insights from clinical trial informationCONCLUSIONSeptember 19, 2011 - USA 36

ConclusionGleaning competitive insights from clinical trial information• Prudent strategic analysis requires a comprehensive view of thecompetitive landscape from the past, present, and future• Publicly available clinical trial information can provide a wealth ofintelligence but it is difficult to collect, assess, and analyze it all• Tools are available to help develop insights and make an informedstrategic decisionWolters Kluwer ConfidentialSeptember 19, 2011 - USA 37

ConclusionGleaning competitive insights from clinical trial informationThank YouStop by booth 6• Learn more about how Adis Clinical Trials Insight• Signup for a free trial• Enter to win an iPadWolters Kluwer Confidential September 19, 2011 - USA 38