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Clinical Competitive Intelligence in 
BIOPHARMACEUTICALS 
DEPICTED 
Therapy Area Competitive Insights and Intelligence 
Uploaded: December 5, 2014
Uploaded: 
December 5, 2014 
Identifying and Elucidating the Clinical Landscape and Prospective 
MARKET OPPORTUNITIES 
Identifying and elucidating clinical landscapes and market opportunities is critical to biopharmaceutical players’ success and 
sustainability in the highly competitive in-market and developmental pipeline sandbox. 
›› Sustainable clinical development programs and lifecycle management via brand and franchise evergreening are 
critical to ethical biopharmaceutical players success among mainstream market opportunities. 
›› Comprehensively understanding the clinical competitive landscape in which an asset sits drives a 360º 
understanding of the “how’s,” “why’s,” “where’s” and “when’s” of competitor actions, movements and initiatives. 
›› Contextualizing the sum total of a clinical competitive landscape enables biopharmceutical players a robust 
and synthetic comprehension of how to win and to competitively maneuver and outmanuever versus the 
competition. 
ALIGNED INTELLIGENCE. FOCUSED RESULTS. 2
Uploaded: 
December 5, 2014 
Illustrative Examples of Clinical Competitive Intelligence – The 2014 In-Market Anticoagulant 
LANDSCAPE OVERVIEW PERSPECTIVE 
CONTEMPORARY 
ANTICOAGULANTS 
Parenteral 
• Unfractionated 
heparin (HMWH) 
• Low molecular 
weight heparin 
(LMWX) 
Oral 
• Warfarin 
NEWER ANTICOAGULANTS 
Parenteral 
• Fondaparinux 
• Argatroban 
• Bivalirudin 
Oral 
• Rivaroxaban 
• Apixaban 
• Dabigatran 
THROMBIN INHIBITORS 
Indirect 
Contemporary 
• HMWH 
• LMWH 
Newer 
• None 
Direct 
Parenteral 
• Argatroban 
• Bivaluridin 
Oral 
• Dabigatran 
FACTOR Xa INHIBITORS 
Contemporary 
• HMWH 
• LMWH 
Newer 
Anticoagulants 
Indirect 
• Fondaparinux 
Direct 
• Rivaroxaban 
• Apixaban 
PARENTERAL ANTICOAGULANTS 
Contemporary 
• Unfractionated 
heparin (HMWH) 
• Low molecular 
weight heparin 
(LMWX) 
Newer 
• Fondaparinux 
• Argatroban 
• Bivalirudin 
ALIGNED INTELLIGENCE. FOCUSED RESULTS. 3
Uploaded: 
December 5, 2014 
Illustrative Examples of Clinical Competitive Intelligence – Competitive Developmental 
PIPELINE IN PSORIASIS (“PsO”) 
INJECTABLES ORAL TREATMENTS TOPICAL TREATMENTS 
CNTO1959 ACT-128800 AN2728 
BT-061 AEB071 CT 327 
Cimzia Alitretinoin E6201 
Ustekinumab ASP015K INCB18424 (ruxolintinib) 
Brodalumab (AMG 827) Apo805K1 LAS41004 
Ixekizumab (LY2439821) BMS-582949 LEO 80185 (Taclonex) 
Secukinumab (AIN457) FP187 LEO 90100 
MK-3222/SCH 900222 Hectoral (Doxercalciferol) PH-10 
LEO 22811 WBI-1001 
Ly3009104 (INCB28050) Ruxolitinib 
SRT2104 Calcipotriene foam (STF 115469) 
VB-201 Tofacitinib (CP-690,550) 
IDP-118 M518101 
Apremilast (CC-10004) CycloPsorb™ 
Apremilast (CC-10004) 
CF101 
Tofacitinib (CP-690,550) 
Voclosporin (ISA247) 
Pre-Clinical Phase 1 Phase 2 Phase 3 Marketed 
ALIGNED INTELLIGENCE. FOCUSED RESULTS. 4
Uploaded: 
December 5, 2014 
Illustrative Examples of Clinical Competitive Intelligence – 
RHEUMATOID ARTHRITIS U.S. PIPELINE 
PHASE 
1 
Antimunocel (Wibi+Works) 
RPI-78 (ReceptoPharm) 
AMP-110 (Medimmune) 
CHR-5154 (Chroma/GSK) 
PRTX-100 (Protalex) 
VGX-1027 (VGX) 
SDP-051 (Adheron) 
ARG-301 (ArGentis) 
Blisibimod (Amgen) 
MK-8457 (Merck) 
CFZ-533 (Novartis) 
Panzema (Entremed) 
OTHERS 
TNF-ALPHA ANTAGONISTS 
Cerdulatinib (Portola) 
AC-430 (Ambit) 
CT-1578 (S*BIO) 
PLX-5622 
(Plexxikon) 
Namilumab 
(Amgen) 
PRT-062607 
(Biogen) 
Peficitinib (Astellas) 
GS-9973 
(CGI Pharma) 
ANTI-CD 
JAK INHIBITORS 
CSF ANTAGONISTS 
SYK INHIBITORS 
PHASE 
2 
PHASE 
3 
LY-3090106 (Eli Lilly) 
REGN-1154 (Regeneron) 
RX-10001 (Resolvyx) 
CF-101 
(Can-Fite) 
Tranilast 
(Kissei) 
MPCs 
(Mesoblast) 
JNJ-38518168 
(J&J) 
MRC-375 
(MRC) 
San-300 
(Salix) 
Oralgam 
(Latona) 
BMS-817399 
(Bristol-Myers) 
CC-292 (Celgene) 
Pro-515 (Proprius) 
Duvelisib 
(Intellikine) 
Fosdagrocorat 
(Pfizer) 
MX-1094* 
(Medinox) 
IR-501* 
(Immune Response) 
Sirukumab 
(J&J) 
Secukinumab 
(Novartis) 
Pateclizumab 
(Roche) 
Ozoralizumab 
(Ablynx) 
ABT-494 (AbbVie) 
INCB-039110 (Incyte) 
Decernotinib 
(Vertex) 
Baricitinib 
(Incyte) 
Sarilumab 
(Regeneron) 
Guselkumab 
(J&J/MorphoSys) 
Ofatumumab 
(Genmab) 
Ustekinumab 
(J&J) 
Ocaratuzumab 
(MENTRIK) 
BIIB-023 
(Biogen) 
INCB-47986 
(Incyte) 
KB-003 
(KaloBios) 
Clazakizumab 
(Alder) 
SBI-087 (Trubion) 
XmAb-5871 
(Xencor) 
Olokizumab 
(R-Pharm) NN-8226 (Novo Nordisk) 
PMI-001 
(Phytomedics) 
MK-8457 (Merck) 
Triolex (Harbor) 
ABT-122 
(AbbVie) 
OPR-003* 
(Vaccinex) 
PF-4236921 
(Pfizer) 
Tregalizumab 
(Biotest/AbbVie) 
INTERLEUKIN 
ANTAGONISTS 
Trial has been put on hold, discontinued, or is inactive 
* Not listed in clinicaltrials.gov or clinicaltrialsregister.eu 
ALIGNED INTELLIGENCE. FOCUSED RESULTS. 5
Uploaded: 
December 5, 2014 
Illustrative Examples of Clinical Competitive Intelligence – 
RHEUMATOID ARTHRITIS LAUNCH TIMELINE 
2014 
U.S. 
EU 
2015 
BMS-817399 
BMS-817399 
Cerdulatinib 
Sarilumab 
Tregalizumab 
rituximab 
adalimumab 
MRC-375 
SBI-087 
INCB-039110 
Sirukumab 
Guselkumab 
Ustekinumab 
Fosdagrocorat 
abatacept 
CC-292 
FC-101 
Filgotinib 
Baricitinib 
Clazakizumab 
MPCS 
Theralizumab 
Duvelisib 
JNJ-38518168 
infliximab 
Decernotinib 
Mavrilimumab 
Olokizumab 
JNJ-527 
2016 2017 2018 2019 
CC-292 
Mavrilimumab 
Olokizumab 
JNJ-38518168 
Decernotinib 
INCB-47986 
TNF-Kinoid 
adalimumab 
abatacept 
Tregalizumab 
Sarilumab 
Theralizumab 
Duvelisib Filgotinib 
FC-101 Baricitinib 
Clazakizumab 
infliximab infliximab 
etanercept 
rituximab 
INCB-039110 
MRC-375 
Fosdagrocorat 
REGN-1154 
Sirukumab 
Others JAK Inhibitor Anti-IL Anti- CD Biosimilars CSF Antagonist Anti-TNF 
ALIGNED INTELLIGENCE. FOCUSED RESULTS. 6
Uploaded: 
December 5, 2014 
The Comprehensive 
COMPETITOR MINDSET 
The comprehensive competitor mindset – a glance into the historical, current and forward-looking perspectives of competitive 
insight and intelligence. 
PAST PERSPECTIVES CURRENT PERSPECTIVES FUTURE PERSPECTIVES 
CLASS OF CI 
ENGAGEMENTS 
››Retrospective analyses 
››Case studies/best practice studies 
››Trend analyses 
››Analogue assessments 
››Comprehensive competitive 
monitoring 
››Conference coverage 
››Competitive technical assessments 
››Competitive gaming exercises 
››Proactive/prospective competitive 
analyses 
››Manufacturing scalability 
assessments 
››Comprehensive landscape 
monitoring 
››Conference coverage 
ROIs CONFERRED 
Gains insight into what the 
competition has done historically; 
depicts competitor key best practices 
and critical failures. 
Demonstrates “real time” analysis of 
what competitors are doing – enables 
PharmaCos to react in “delayed 
real time.” (i.e.- there is a time lag 
between the receipt of intelligence 
and a concerted response.) 
Elucidates forward-looking strategic 
intent and tactical implementation of 
competitors; enables PharmaCos to 
plan in advance targeted responses 
to competitor actions. 
ALIGNED INTELLIGENCE. FOCUSED RESULTS. 7
Uploaded: 
December 5, 2014 
Molekule Consulting’s Three-Step 
COMPETITIVE INTELLIGENCE FILTER 
Competitive data alone in a vaccuum are not intelligence...competitive intelligence is derived for robust contextualization, 
analysis and synthesis. 
FILTER #1 
Multiple disparate pieces of 
competitive data 
CONTEXTUALIZATION 
Actionable 
Competitive Intelligence 
FILTER #2 FILTER #3 
ANALYSIS SYNTHESIS 
ALIGNED INTELLIGENCE. FOCUSED RESULTS. 8
Uploaded: 
December 5, 2014 
Clinical Competitive Intelligence 
IN REVIEW 
›› Clinical competitive intelligence is critical to ethical biopharmaceutical players’ strategic and tactical toolkits, as 
it enables them to identify and elucidate competitive threats, weaknesses and market opportunities 
›› Analyzing clinical competitive intelligence from a past, present and forward-looking perspective provides a 
holistic perspective of the clinical landscape and competitive sandbox from past performance to current market 
trends and future competitive opportunities 
›› The application of three (3) key filters – #1 contextualization, #2 analysis and #3 synthesis to competitive data 
yields actionable and leverageable clinical competitive intelligence 
ALIGNED INTELLIGENCE. FOCUSED RESULTS. 9
DAVID ALDERMAN 
President 
CL +1 305 504 3030 
EM dalderman@molekuleconsulting.com 
Basel, CH 
PH +41 61 588 04 77 
Boston, MA 
PH +1 617 752 3420 
FX +1 617 463 9340 
Brussels, BE 
PH +32 7 848 03 80 
Chicago, IL 
PH +1 312 585 6040 
FX +1 312 585 6780 
London, UK 
PH +44 20 3318 4750 
New York, NY 
PH +1 646 568 5400 
FX +1 646 568 5170 
Prague, CZ 
PH +420 576 880 005 
San Francisco, CA 
PH +1 650 449 7680 
FX +1 650 449 7447 
São Paulo, BS 
PH +55 11 32301580 
FX +55 11 32301680 
Tel Aviv, IL 
PH +972 3 7208759 
Tokyo, JP 
PH +81 345 789470 
1395 Brickell Avenue 
Suite 800 
Miami, FL 33131 
TF +1 877 778 5110 
PH +1 786 600 2410 
FX +1 786 600 3140 
EM info@molekuleconsulting.com 
www.molekuleconsulting.com

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MolekuleConsulting_ClinicalCompetitiveIntelligence_12.5.14

  • 1. Clinical Competitive Intelligence in BIOPHARMACEUTICALS DEPICTED Therapy Area Competitive Insights and Intelligence Uploaded: December 5, 2014
  • 2. Uploaded: December 5, 2014 Identifying and Elucidating the Clinical Landscape and Prospective MARKET OPPORTUNITIES Identifying and elucidating clinical landscapes and market opportunities is critical to biopharmaceutical players’ success and sustainability in the highly competitive in-market and developmental pipeline sandbox. ›› Sustainable clinical development programs and lifecycle management via brand and franchise evergreening are critical to ethical biopharmaceutical players success among mainstream market opportunities. ›› Comprehensively understanding the clinical competitive landscape in which an asset sits drives a 360º understanding of the “how’s,” “why’s,” “where’s” and “when’s” of competitor actions, movements and initiatives. ›› Contextualizing the sum total of a clinical competitive landscape enables biopharmceutical players a robust and synthetic comprehension of how to win and to competitively maneuver and outmanuever versus the competition. ALIGNED INTELLIGENCE. FOCUSED RESULTS. 2
  • 3. Uploaded: December 5, 2014 Illustrative Examples of Clinical Competitive Intelligence – The 2014 In-Market Anticoagulant LANDSCAPE OVERVIEW PERSPECTIVE CONTEMPORARY ANTICOAGULANTS Parenteral • Unfractionated heparin (HMWH) • Low molecular weight heparin (LMWX) Oral • Warfarin NEWER ANTICOAGULANTS Parenteral • Fondaparinux • Argatroban • Bivalirudin Oral • Rivaroxaban • Apixaban • Dabigatran THROMBIN INHIBITORS Indirect Contemporary • HMWH • LMWH Newer • None Direct Parenteral • Argatroban • Bivaluridin Oral • Dabigatran FACTOR Xa INHIBITORS Contemporary • HMWH • LMWH Newer Anticoagulants Indirect • Fondaparinux Direct • Rivaroxaban • Apixaban PARENTERAL ANTICOAGULANTS Contemporary • Unfractionated heparin (HMWH) • Low molecular weight heparin (LMWX) Newer • Fondaparinux • Argatroban • Bivalirudin ALIGNED INTELLIGENCE. FOCUSED RESULTS. 3
  • 4. Uploaded: December 5, 2014 Illustrative Examples of Clinical Competitive Intelligence – Competitive Developmental PIPELINE IN PSORIASIS (“PsO”) INJECTABLES ORAL TREATMENTS TOPICAL TREATMENTS CNTO1959 ACT-128800 AN2728 BT-061 AEB071 CT 327 Cimzia Alitretinoin E6201 Ustekinumab ASP015K INCB18424 (ruxolintinib) Brodalumab (AMG 827) Apo805K1 LAS41004 Ixekizumab (LY2439821) BMS-582949 LEO 80185 (Taclonex) Secukinumab (AIN457) FP187 LEO 90100 MK-3222/SCH 900222 Hectoral (Doxercalciferol) PH-10 LEO 22811 WBI-1001 Ly3009104 (INCB28050) Ruxolitinib SRT2104 Calcipotriene foam (STF 115469) VB-201 Tofacitinib (CP-690,550) IDP-118 M518101 Apremilast (CC-10004) CycloPsorb™ Apremilast (CC-10004) CF101 Tofacitinib (CP-690,550) Voclosporin (ISA247) Pre-Clinical Phase 1 Phase 2 Phase 3 Marketed ALIGNED INTELLIGENCE. FOCUSED RESULTS. 4
  • 5. Uploaded: December 5, 2014 Illustrative Examples of Clinical Competitive Intelligence – RHEUMATOID ARTHRITIS U.S. PIPELINE PHASE 1 Antimunocel (Wibi+Works) RPI-78 (ReceptoPharm) AMP-110 (Medimmune) CHR-5154 (Chroma/GSK) PRTX-100 (Protalex) VGX-1027 (VGX) SDP-051 (Adheron) ARG-301 (ArGentis) Blisibimod (Amgen) MK-8457 (Merck) CFZ-533 (Novartis) Panzema (Entremed) OTHERS TNF-ALPHA ANTAGONISTS Cerdulatinib (Portola) AC-430 (Ambit) CT-1578 (S*BIO) PLX-5622 (Plexxikon) Namilumab (Amgen) PRT-062607 (Biogen) Peficitinib (Astellas) GS-9973 (CGI Pharma) ANTI-CD JAK INHIBITORS CSF ANTAGONISTS SYK INHIBITORS PHASE 2 PHASE 3 LY-3090106 (Eli Lilly) REGN-1154 (Regeneron) RX-10001 (Resolvyx) CF-101 (Can-Fite) Tranilast (Kissei) MPCs (Mesoblast) JNJ-38518168 (J&J) MRC-375 (MRC) San-300 (Salix) Oralgam (Latona) BMS-817399 (Bristol-Myers) CC-292 (Celgene) Pro-515 (Proprius) Duvelisib (Intellikine) Fosdagrocorat (Pfizer) MX-1094* (Medinox) IR-501* (Immune Response) Sirukumab (J&J) Secukinumab (Novartis) Pateclizumab (Roche) Ozoralizumab (Ablynx) ABT-494 (AbbVie) INCB-039110 (Incyte) Decernotinib (Vertex) Baricitinib (Incyte) Sarilumab (Regeneron) Guselkumab (J&J/MorphoSys) Ofatumumab (Genmab) Ustekinumab (J&J) Ocaratuzumab (MENTRIK) BIIB-023 (Biogen) INCB-47986 (Incyte) KB-003 (KaloBios) Clazakizumab (Alder) SBI-087 (Trubion) XmAb-5871 (Xencor) Olokizumab (R-Pharm) NN-8226 (Novo Nordisk) PMI-001 (Phytomedics) MK-8457 (Merck) Triolex (Harbor) ABT-122 (AbbVie) OPR-003* (Vaccinex) PF-4236921 (Pfizer) Tregalizumab (Biotest/AbbVie) INTERLEUKIN ANTAGONISTS Trial has been put on hold, discontinued, or is inactive * Not listed in clinicaltrials.gov or clinicaltrialsregister.eu ALIGNED INTELLIGENCE. FOCUSED RESULTS. 5
  • 6. Uploaded: December 5, 2014 Illustrative Examples of Clinical Competitive Intelligence – RHEUMATOID ARTHRITIS LAUNCH TIMELINE 2014 U.S. EU 2015 BMS-817399 BMS-817399 Cerdulatinib Sarilumab Tregalizumab rituximab adalimumab MRC-375 SBI-087 INCB-039110 Sirukumab Guselkumab Ustekinumab Fosdagrocorat abatacept CC-292 FC-101 Filgotinib Baricitinib Clazakizumab MPCS Theralizumab Duvelisib JNJ-38518168 infliximab Decernotinib Mavrilimumab Olokizumab JNJ-527 2016 2017 2018 2019 CC-292 Mavrilimumab Olokizumab JNJ-38518168 Decernotinib INCB-47986 TNF-Kinoid adalimumab abatacept Tregalizumab Sarilumab Theralizumab Duvelisib Filgotinib FC-101 Baricitinib Clazakizumab infliximab infliximab etanercept rituximab INCB-039110 MRC-375 Fosdagrocorat REGN-1154 Sirukumab Others JAK Inhibitor Anti-IL Anti- CD Biosimilars CSF Antagonist Anti-TNF ALIGNED INTELLIGENCE. FOCUSED RESULTS. 6
  • 7. Uploaded: December 5, 2014 The Comprehensive COMPETITOR MINDSET The comprehensive competitor mindset – a glance into the historical, current and forward-looking perspectives of competitive insight and intelligence. PAST PERSPECTIVES CURRENT PERSPECTIVES FUTURE PERSPECTIVES CLASS OF CI ENGAGEMENTS ››Retrospective analyses ››Case studies/best practice studies ››Trend analyses ››Analogue assessments ››Comprehensive competitive monitoring ››Conference coverage ››Competitive technical assessments ››Competitive gaming exercises ››Proactive/prospective competitive analyses ››Manufacturing scalability assessments ››Comprehensive landscape monitoring ››Conference coverage ROIs CONFERRED Gains insight into what the competition has done historically; depicts competitor key best practices and critical failures. Demonstrates “real time” analysis of what competitors are doing – enables PharmaCos to react in “delayed real time.” (i.e.- there is a time lag between the receipt of intelligence and a concerted response.) Elucidates forward-looking strategic intent and tactical implementation of competitors; enables PharmaCos to plan in advance targeted responses to competitor actions. ALIGNED INTELLIGENCE. FOCUSED RESULTS. 7
  • 8. Uploaded: December 5, 2014 Molekule Consulting’s Three-Step COMPETITIVE INTELLIGENCE FILTER Competitive data alone in a vaccuum are not intelligence...competitive intelligence is derived for robust contextualization, analysis and synthesis. FILTER #1 Multiple disparate pieces of competitive data CONTEXTUALIZATION Actionable Competitive Intelligence FILTER #2 FILTER #3 ANALYSIS SYNTHESIS ALIGNED INTELLIGENCE. FOCUSED RESULTS. 8
  • 9. Uploaded: December 5, 2014 Clinical Competitive Intelligence IN REVIEW ›› Clinical competitive intelligence is critical to ethical biopharmaceutical players’ strategic and tactical toolkits, as it enables them to identify and elucidate competitive threats, weaknesses and market opportunities ›› Analyzing clinical competitive intelligence from a past, present and forward-looking perspective provides a holistic perspective of the clinical landscape and competitive sandbox from past performance to current market trends and future competitive opportunities ›› The application of three (3) key filters – #1 contextualization, #2 analysis and #3 synthesis to competitive data yields actionable and leverageable clinical competitive intelligence ALIGNED INTELLIGENCE. FOCUSED RESULTS. 9
  • 10. DAVID ALDERMAN President CL +1 305 504 3030 EM dalderman@molekuleconsulting.com Basel, CH PH +41 61 588 04 77 Boston, MA PH +1 617 752 3420 FX +1 617 463 9340 Brussels, BE PH +32 7 848 03 80 Chicago, IL PH +1 312 585 6040 FX +1 312 585 6780 London, UK PH +44 20 3318 4750 New York, NY PH +1 646 568 5400 FX +1 646 568 5170 Prague, CZ PH +420 576 880 005 San Francisco, CA PH +1 650 449 7680 FX +1 650 449 7447 São Paulo, BS PH +55 11 32301580 FX +55 11 32301680 Tel Aviv, IL PH +972 3 7208759 Tokyo, JP PH +81 345 789470 1395 Brickell Avenue Suite 800 Miami, FL 33131 TF +1 877 778 5110 PH +1 786 600 2410 FX +1 786 600 3140 EM info@molekuleconsulting.com www.molekuleconsulting.com