High Affinity Nerve Growth Factor Receptor (Neurotrophic Tyrosine Kinase Receptor Type 1 or TRK1 Transforming Tyrosine Kinase Protein or Tropomyosin Related Kinase A or Tyrosine Kinase Receptor or gp140trk or p140 TrkA or NTRK1 or EC 2.7.10.1) – Pipeline Review, H2 2016

Global Markets Direct’s, ‘High Affinity Nerve Growth Factor Receptor (Neurotrophic Tyrosine Kinase Receptor Type 1 or TRK1 Transforming Tyrosine Kinase Protein or Tropomyosin Related Kinase A or Tyrosine Kinase Receptor or gp140trk or p140 TrkA or NTRK1 or EC 2.7.10.1) – Pipeline Review, H2 2016’, provides in depth analysis on High Affinity Nerve Growth Factor Receptor (Neurotrophic Tyrosine Kinase Receptor Type 1 or TRK1 Transforming Tyrosine Kinase Protein or Tropomyosin Related Kinase A or Tyrosine Kinase Receptor or gp140trk or p140 TrkA or NTRK1 or EC 2.7.10.1) targeted pipeline therapeutics.

The report provides comprehensive information on the High Affinity Nerve Growth Factor Receptor (Neurotrophic Tyrosine Kinase Receptor Type 1 or TRK1 Transforming Tyrosine Kinase Protein or Tropomyosin Related Kinase A or Tyrosine Kinase Receptor or gp140trk or p140 TrkA or NTRK1 or EC 2.7.10.1), targeted therapeutics, complete with analysis by indications, stage of development, mechanism of action (MoA), route of administration (RoA) and molecule type. The report also covers the descriptive pharmacological action of the therapeutics, its complete research and development history and latest news and press releases. Additionally, the report provides an overview of key players involved in High Affinity Nerve Growth Factor Receptor (Neurotrophic Tyrosine Kinase Receptor Type 1 or TRK1 Transforming Tyrosine Kinase Protein or Tropomyosin Related Kinase A or Tyrosine Kinase Receptor or gp140trk or p140 TrkA or NTRK1 or EC 2.7.10.1) targeted therapeutics development and features dormant and discontinued projects.

Global Markets Direct’s report features investigational drugs from across globe covering over 20 therapy areas and nearly 3,000 indications. The report is built using data and information sourced from Global Markets Direct’s proprietary databases, company/university websites, clinical trial registries, conferences, SEC filings, investor presentations and featured press releases from company/university sites and industry-specific third party sources. Drug profiles featured in the report undergoes periodic review following a stringent set of processes to ensure that all the profiles are updated with the latest set of information. Additionally, various dynamic tracking processes ensure that the most recent developments are captured on a real time basis.

The report helps in identifying and tracking emerging players in the market and their portfolios, enhances decision making capabilities and helps to create effective counter strategies to gain competitive advantage.

Note: Certain sections in the report may be removed or altered based on the availability and relevance of data.

Scope

The report provides a snapshot of the global therapeutic landscape for High Affinity Nerve Growth Factor Receptor (Neurotrophic Tyrosine Kinase Receptor Type 1 or TRK1 Transforming Tyrosine Kinase Protein or Tropomyosin Related Kinase A or Tyrosine Kinase Receptor or gp140trk or p140 TrkA or NTRK1 or EC 2.7.10.1)

The report reviews High Affinity Nerve Growth Factor Receptor (Neurotrophic Tyrosine Kinase Receptor Type 1 or TRK1 Transforming Tyrosine Kinase Protein or Tropomyosin Related Kinase A or Tyrosine Kinase Receptor or gp140trk or p140 TrkA or NTRK1 or EC 2.7.10.1) targeted therapeutics under development by companies and universities/research institutes based on information derived from company and industry-specific sources

The report covers pipeline products based on various stages of development ranging from pre-registration till discovery and undisclosed stages

The report features descriptive drug profiles for the pipeline products which includes, product description, descriptive MoA, R&D brief, licensing and collaboration details & other developmental activities

The report reviews key players involved in High Affinity Nerve Growth Factor Receptor (Neurotrophic Tyrosine Kinase Receptor Type 1 or TRK1 Transforming Tyrosine Kinase Protein or Tropomyosin Related Kinase A or Tyrosine Kinase Receptor or gp140trk or p140 TrkA or NTRK1 or EC 2.7.10.1) targeted therapeutics and enlists all their major and minor projects

The report assesses High Affinity Nerve Growth Factor Receptor (Neurotrophic Tyrosine Kinase Receptor Type 1 or TRK1 Transforming Tyrosine Kinase Protein or Tropomyosin Related Kinase A or Tyrosine Kinase Receptor or gp140trk or p140 TrkA or NTRK1 or EC 2.7.10.1) targeted therapeutics based on mechanism of action (MoA), route of administration (RoA) and molecule type

The report summarizes all the dormant and discontinued pipeline projects

The report reviews latest news and deals related to High Affinity Nerve Growth Factor Receptor (Neurotrophic Tyrosine Kinase Receptor Type 1 or TRK1 Transforming Tyrosine Kinase Protein or Tropomyosin Related Kinase A or Tyrosine Kinase Receptor or gp140trk or p140 TrkA or NTRK1 or EC 2.7.10.1) targeted therapeutics

Reasons to buy

Gain strategically significant competitor information, analysis, and insights to formulate effective R&D strategies

Identify emerging players with potentially strong product portfolio and create effective counter-strategies to gain competitive advantage

Identify and understand the targeted therapy areas and indications for High Affinity Nerve Growth Factor Receptor (Neurotrophic Tyrosine Kinase Receptor Type 1 or TRK1 Transforming Tyrosine Kinase Protein or Tropomyosin Related Kinase A or Tyrosine Kinase Receptor or gp140trk or p140 TrkA or NTRK1 or EC 2.7.10.1)

Identify the use of drugs for target identification and drug repurposing

Identify potential new clients or partners in the target demographic

Develop strategic initiatives by understanding the focus areas of leading companies

Plan mergers and acquisitions effectively by identifying key players and it’s most promising pipeline therapeutics

Devise corrective measures for pipeline projects by understanding High Affinity Nerve Growth Factor Receptor (Neurotrophic Tyrosine Kinase Receptor Type 1 or TRK1 Transforming Tyrosine Kinase Protein or Tropomyosin Related Kinase A or Tyrosine Kinase Receptor or gp140trk or p140 TrkA or NTRK1 or EC 2.7.10.1) development landscape

Develop and design in-licensing and out-licensing strategies by identifying prospective partners with the most attractive projects to enhance and expand business potential and scope

Companies mentioned

Array BioPharma Inc.

Astellas Pharma Inc.

AstraZeneca Plc

Creabilis SA

Daiichi Sankyo Company, Limited

Dompe Farmaceutici S.p.A.

Genzyme Corporation

Glenmark Pharmaceuticals Ltd.

Ignyta, Inc.

Loxo Oncology, Inc.

Mimetogen Pharmaceuticals Inc.

Nerviano Medical Sciences S.r.l.

Purdue Pharma L.P.

SOM Innovation Biotech SL

Tiziana Life Sciences Plc

Table of Contents

Table of Contents

Table of Contents 2

List of Tables 6

List of Figures 7

Introduction 8

Global Markets Direct Report Coverage 8

High Affinity Nerve Growth Factor Receptor (Neurotrophic Tyrosine Kinase Receptor Type 1 or TRK1 Transforming Tyrosine Kinase Protein or Tropomyosin Related Kinase A or Tyrosine Kinase Receptor or gp140trk or p140 TrkA or NTRK1 or EC

2.7.10.1) Overview 9

Therapeutics Development 10

High Affinity Nerve Growth Factor Receptor (Neurotrophic Tyrosine Kinase Receptor Type 1 or TRK1 Transforming Tyrosine Kinase Protein or Tropomyosin Related Kinase A or Tyrosine Kinase Receptor or gp140trk or p140 TrkA or NTRK1 or EC

2.7.10.1) - Products under Development by Stage of Development 10

High Affinity Nerve Growth Factor Receptor (Neurotrophic Tyrosine Kinase Receptor Type 1 or TRK1 Transforming Tyrosine Kinase Protein or Tropomyosin Related Kinase A or Tyrosine Kinase Receptor or gp140trk or p140 TrkA or NTRK1 or EC

2.7.10.1) - Products under Development by Therapy Area 11

High Affinity Nerve Growth Factor Receptor (Neurotrophic Tyrosine Kinase Receptor Type 1 or TRK1 Transforming Tyrosine Kinase Protein or Tropomyosin Related Kinase A or Tyrosine Kinase Receptor or gp140trk or p140 TrkA or NTRK1 or EC

2.7.10.1) - Products under Development by Indication 12

High Affinity Nerve Growth Factor Receptor (Neurotrophic Tyrosine Kinase Receptor Type 1 or TRK1 Transforming Tyrosine Kinase Protein or Tropomyosin Related Kinase A or Tyrosine Kinase Receptor or gp140trk or p140 TrkA or NTRK1 or EC

2.7.10.1) - Pipeline Products Glance 14

Late Stage Products 14

Early Stage Products 15

High Affinity Nerve Growth Factor Receptor (Neurotrophic Tyrosine Kinase Receptor Type 1 or TRK1 Transforming Tyrosine Kinase Protein or Tropomyosin Related Kinase A or Tyrosine Kinase Receptor or gp140trk or p140 TrkA or NTRK1 or EC

2.7.10.1) - Products under Development by Companies 16

High Affinity Nerve Growth Factor Receptor (Neurotrophic Tyrosine Kinase Receptor Type 1 or TRK1 Transforming Tyrosine Kinase Protein or Tropomyosin Related Kinase A or Tyrosine Kinase Receptor or gp140trk or p140 TrkA or NTRK1 or EC

2.7.10.1) - Products under Development by Universities/Institutes 21

High Affinity Nerve Growth Factor Receptor (Neurotrophic Tyrosine Kinase Receptor Type 1 or TRK1 Transforming Tyrosine Kinase Protein or Tropomyosin Related Kinase A or Tyrosine Kinase Receptor or gp140trk or p140 TrkA or NTRK1 or EC

2.7.10.1) - Therapeutics Assessment 23

Assessment by Monotherapy/Combination Products 23

Assessment by Mechanism of Action 24

Assessment by Route of Administration 26

Assessment by Molecule Type 28

High Affinity Nerve Growth Factor Receptor (Neurotrophic Tyrosine Kinase Receptor Type 1 or TRK1 Transforming Tyrosine Kinase Protein or Tropomyosin Related Kinase A or Tyrosine Kinase Receptor or gp140trk or p140 TrkA or NTRK1 or EC

2.7.10.1) - Companies Involved in Therapeutics Development 30

Array BioPharma Inc. 30

Astellas Pharma Inc. 31

AstraZeneca Plc 32

Creabilis SA 33

Daiichi Sankyo Company, Limited 34

Dompe Farmaceutici S.p.A. 35

Genzyme Corporation 36

Glenmark Pharmaceuticals Ltd. 37

Ignyta, Inc. 38

Loxo Oncology, Inc. 39

Mimetogen Pharmaceuticals Inc. 40

Nerviano Medical Sciences S.r.l. 41

Purdue Pharma L.P. 42

SOM Innovation Biotech SL 43

Tiziana Life Sciences Plc 44

High Affinity Nerve Growth Factor Receptor (Neurotrophic Tyrosine Kinase Receptor Type 1 or TRK1 Transforming Tyrosine Kinase Protein or Tropomyosin Related Kinase A or Tyrosine Kinase Receptor or gp140trk or p140 TrkA or NTRK1 or EC

2.7.10.1) - Drug Profiles 45

AR-523 - Drug Profile 45

Product Description 45

Mechanism Of Action 45

R&D Progress 45

AR-786 - Drug Profile 46

Product Description 46

Mechanism Of Action 46

R&D Progress 46

ARRY-954 - Drug Profile 47

Product Description 47

Mechanism Of Action 47

R&D Progress 47

ASP-7962 - Drug Profile 48

Product Description 48

Mechanism Of Action 48

R&D Progress 48

AZ-64 - Drug Profile 49

Product Description 49

Mechanism Of Action 49

R&D Progress 49

AZD-7451 - Drug Profile 50

Product Description 50

Mechanism Of Action 50

R&D Progress 50

CRB-0089 - Drug Profile 51

Product Description 51

Mechanism Of Action 51

R&D Progress 51

CT-327 - Drug Profile 52

Product Description 52

Mechanism Of Action 52

R&D Progress 52

CT-340 - Drug Profile 55

Product Description 55

Mechanism Of Action 55

R&D Progress 55

entrectinib - Drug Profile 56

Product Description 56

Mechanism Of Action 56

R&D Progress 56

GBR-900 - Drug Profile 62

Product Description 62

Mechanism Of Action 62

R&D Progress 62

GZ-389988 - Drug Profile 63

Product Description 63

Mechanism Of Action 63

R&D Progress 63

lestaurtinib - Drug Profile 64

Product Description 64

Mechanism Of Action 64

R&D Progress 64

LOXO-101 - Drug Profile 65

Product Description 65

Mechanism Of Action 65

R&D Progress 65

milciclib - Drug Profile 70

Product Description 70

Mechanism Of Action 70

R&D Progress 70

Monoclonal Antibody to Inhibit TrkA for Central Nervous System Disorders - Drug Profile 72

Product Description 72

Mechanism Of Action 72

R&D Progress 72

NMSP-626 - Drug Profile 73

Product Description 73

Mechanism Of Action 73

R&D Progress 73

PLX-7486 - Drug Profile 74

Product Description 74

Mechanism Of Action 74

R&D Progress 74

Recombinant Protein to Agonize p75NTR and Trk for Ophthalmology - Drug Profile 75

Product Description 75

Mechanism Of Action 75

R&D Progress 75

Synthetic Peptide for Neurology - Drug Profile 77

Product Description 77

Mechanism Of Action 77

R&D Progress 77

tavilermide hydrochloride - Drug Profile 78

Product Description 78

Mechanism Of Action 78

R&D Progress 78

VM-902A - Drug Profile 80

Product Description 80

Mechanism Of Action 80

R&D Progress 80

High Affinity Nerve Growth Factor Receptor (Neurotrophic Tyrosine Kinase Receptor Type 1 or TRK1 Transforming Tyrosine Kinase Protein or Tropomyosin Related Kinase A or Tyrosine Kinase Receptor or gp140trk or p140 TrkA or NTRK1 or EC

2.7.10.1) - Dormant Projects 81

High Affinity Nerve Growth Factor Receptor (Neurotrophic Tyrosine Kinase Receptor Type 1 or TRK1 Transforming Tyrosine Kinase Protein or Tropomyosin Related Kinase A or Tyrosine Kinase Receptor or gp140trk or p140 TrkA or NTRK1 or EC

2.7.10.1) - Discontinued Products 86

High Affinity Nerve Growth Factor Receptor (Neurotrophic Tyrosine Kinase Receptor Type 1 or TRK1 Transforming Tyrosine Kinase Protein or Tropomyosin Related Kinase A or Tyrosine Kinase Receptor or gp140trk or p140 TrkA or NTRK1 or EC

2.7.10.1) - Featured News & Press Releases 89

Jul 13, 2016: Loxo Oncology Receives Breakthrough Therapy Designation from U.S. Food and Drug Administration for LOXO-101 89

Jun 15, 2016: Loxo Oncology Accepts Invitation to Present LOXO-101 to the FDA's Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee 89

Apr 19, 2016: Loxo Oncology Announces First Pediatric Response to LOXO-101 90

Apr 17, 2016: Loxo Oncology TRK Inhibitor LOXO-101 Shows Durable Anti-Tumor Activity Across TRK Fusion Cancers in AACR Phase 1 Update 91

Apr 17, 2016: Ignyta Announces Updated Data from Entrectinib Phase 1 Clinical Trials at the 2016 AACR Annual Meeting 94

Apr 11, 2016: Loxo Oncology to Present Updated LOXO-101 Phase 1 Data at the 2016 AACR Annual Meeting 96

Apr 07, 2016: Ignyta Announces Oral Plenary Presentation and Poster Presentations at the 2016 AACR Annual Meeting 97

Jan 15, 2016: Loxo Oncology Announces EMA Orphan Drug Designation Granted to LOXO-101 for Treatment of Soft Tissue Sarcoma 98

Dec 22, 2015: Loxo Oncology Announces First Patient Enrolled in Phase 1 Trial of LOXO-101 in Pediatric Cancer Patients 98

Dec 09, 2015: Ignyta Announces Initiation of STARTRK "Next Generation" Phase 1/1b Pediatric Clinical Trial of Entrectinib 99

Dec 08, 2015: Ignyta Receives Orphan Drug Designation in the European Union for Entrectinib for the Treatment of Neuroblastoma 100

Dec 02, 2015: rhNGF, the Dompe Biotech Molecule for the Treatment of Neurotrophic Keratitis, Receives Orphan Drug Designation from the European Medicines Agency 100

Nov 30, 2015: Ignyta and EORTC Announce Entrectinib Selected as First Investigational Cancer Agent to be Included in EORTC SPECTA Precision Medicine Clinical Trial Program 101

Nov 08, 2015: Loxo Oncology TRK Inhibitor LOXO-101 Demonstrates Promising Clinical Activity and Safety in Phase 1 Trial 102

Oct 28, 2015: Loxo Oncology Announces Selection of LOXO-101 for NCI-MATCH Precision Medicine Clinical Trial 103

Appendix 105

Methodology 105

Coverage 105

Secondary Research 105

Primary Research 105

Expert Panel Validation 105

Contact Us 105

Disclaimer 106

List of Tables

List of Tables

Number of Products under Development for, H2 2016 10

Number of Products under Development by Therapy Area, H2 2016 11

Number of Products under Development by Indication, H2 2016 12

Comparative Analysis by Late Stage Development, H2 2016 14

Comparative Analysis by Early Stage Products, H2 2016 15

Number of Products under Development by Companies, H2 2016 16

Products under Development by Companies, H2 2016 17

Products under Development by Companies, H2 2016 (Contd..1) 18

Products under Development by Companies, H2 2016 (Contd..2) 19

Products under Development by Companies, H2 2016 (Contd..3) 20

Number of Products under Investigation by Universities/Institutes, H2 2016 21

Products under Investigation by Universities/Institutes, H2 2016 22

Assessment by Monotherapy/Combination Products, H2 2016 23

Number of Products by Stage and Mechanism of Action, H2 2016 25

Number of Products by Stage and Route of Administration, H2 2016 27

Number of Products by Stage and Molecule Type, H2 2016 29

Pipeline by Array BioPharma Inc., H2 2016 30

Pipeline by Astellas Pharma Inc., H2 2016 31

Pipeline by AstraZeneca Plc, H2 2016 32

Pipeline by Creabilis SA, H2 2016 33

Pipeline by Daiichi Sankyo Company, Limited, H2 2016 34

Pipeline by Dompe Farmaceutici S.p.A., H2 2016 35

Pipeline by Genzyme Corporation, H2 2016 36

Pipeline by Glenmark Pharmaceuticals Ltd., H2 2016 37

Pipeline by Ignyta, Inc., H2 2016 38

Pipeline by Loxo Oncology, Inc., H2 2016 39

Pipeline by Mimetogen Pharmaceuticals Inc., H2 2016 40

Pipeline by Nerviano Medical Sciences S.r.l., H2 2016 41

Pipeline by Purdue Pharma L.P., H2 2016 42

Pipeline by SOM Innovation Biotech SL, H2 2016 43

Pipeline by Tiziana Life Sciences Plc, H2 2016 44

Dormant Projects, H2 2016 81

Dormant Projects (Contd..1), H2 2016 82

Dormant Projects (Contd..2), H2 2016 83

Dormant Projects (Contd..3), H2 2016 84

Dormant Projects (Contd..4), H2 2016 85

Discontinued Products, H2 2016 86

Discontinued Products (Contd..1), H2 2016 87

Discontinued Products (Contd..2), H2 2016 88

List of Figures

List of Figures

Number of Products under Development for, H2 2016 10

Number of Products under Development by Therapy Area, H2 2016 11

Number of Products under Development by Top 10 Indication, H2 2016 12

Comparative Analysis by Late Stage Development, H2 2016 14

Comparative Analysis by Early Stage Products, H2 2016 15

Assessment by Monotherapy/Combination Products, H2 2016 23

Number of Products by Mechanism of Actions, H2 2016 24

Number of Products by Stage and Mechanism of Actions, H2 2016 24

Number of Products by Routes of Administration, H2 2016 26

Number of Products by Stage and Routes of Administration, H2 2016 26

Number of Products by Molecule Types, H2 2016 28

Number of Products by Stage and Molecule Type, H2 2016 28

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