Fibroblast Growth Factor Receptor 4 (CD334 or FGFR4 or EC 2.7.10.1) – Pipeline Review, H2 2016

Global Markets Direct’s, ‘Fibroblast Growth Factor Receptor 4 (CD334 or FGFR4 or EC 2.7.10.1) – Pipeline Review, H2 2016’, provides in depth analysis on Fibroblast Growth Factor Receptor 4 (CD334 or FGFR4 or EC 2.7.10.1) targeted pipeline therapeutics.

The report provides comprehensive information on the Fibroblast Growth Factor Receptor 4 (CD334 or FGFR4 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 Fibroblast Growth Factor Receptor 4 (CD334 or FGFR4 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 Fibroblast Growth Factor Receptor 4 (CD334 or FGFR4 or EC 2.7.10.1)

The report reviews Fibroblast Growth Factor Receptor 4 (CD334 or FGFR4 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 Fibroblast Growth Factor Receptor 4 (CD334 or FGFR4 or EC 2.7.10.1) targeted therapeutics and enlists all their major and minor projects

The report assesses Fibroblast Growth Factor Receptor 4 (CD334 or FGFR4 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 Fibroblast Growth Factor Receptor 4 (CD334 or FGFR4 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 Fibroblast Growth Factor Receptor 4 (CD334 or FGFR4 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 Fibroblast Growth Factor Receptor 4 (CD334 or FGFR4 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

Amgen Inc.

ArQule, Inc.

Astellas Pharma Inc.

AstraZeneca Plc

AVEO Pharmaceuticals, Inc.

Blueprint Medicines Corporation

Bristol-Myers Squibb Company

Daiichi Sankyo Company, Limited

Eddingpharm

Eisai Co., Ltd.

Eli Lilly and Company

Genosco

H3 Biomedicine Inc.

Ionis Pharmaceuticals, Inc.

Johnson & Johnson

NGM Biopharmaceuticals, Inc.

Novartis AG

Principia Biopharma Inc.

Vichem Chemie Research Ltd.

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

Fibroblast Growth Factor Receptor 4 (CD334 or FGFR4 or EC

2.7.10.1) Overview 9

Therapeutics Development 10

Fibroblast Growth Factor Receptor 4 (CD334 or FGFR4 or EC

2.7.10.1) - Products under Development by Stage of Development 10

Fibroblast Growth Factor Receptor 4 (CD334 or FGFR4 or EC

2.7.10.1) - Products under Development by Therapy Area 11

Fibroblast Growth Factor Receptor 4 (CD334 or FGFR4 or EC

2.7.10.1) - Products under Development by Indication 12

Fibroblast Growth Factor Receptor 4 (CD334 or FGFR4 or EC

2.7.10.1) - Pipeline Products Glance 14

Late Stage Products 14

Early Stage Products 15

Fibroblast Growth Factor Receptor 4 (CD334 or FGFR4 or EC

2.7.10.1) - Products under Development by Companies 16

Fibroblast Growth Factor Receptor 4 (CD334 or FGFR4 or EC

2.7.10.1) - Products under Development by Universities/Institutes 21

Fibroblast Growth Factor Receptor 4 (CD334 or FGFR4 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

Fibroblast Growth Factor Receptor 4 (CD334 or FGFR4 or EC

2.7.10.1) - Companies Involved in Therapeutics Development 30

Amgen Inc. 30

ArQule, Inc. 31

Astellas Pharma Inc. 32

AstraZeneca Plc 33

AVEO Pharmaceuticals, Inc. 34

Blueprint Medicines Corporation 35

Bristol-Myers Squibb Company 36

Daiichi Sankyo Company, Limited 37

Eddingpharm 38

Eisai Co., Ltd. 39

Eli Lilly and Company 41

Genosco 42

H3 Biomedicine Inc. 43

Ionis Pharmaceuticals, Inc. 44

Johnson & Johnson 45

NGM Biopharmaceuticals, Inc. 46

Novartis AG 47

Principia Biopharma Inc. 48

Vichem Chemie Research Ltd. 49

Fibroblast Growth Factor Receptor 4 (CD334 or FGFR4 or EC

2.7.10.1) - Drug Profiles 50

ARQ-087 - Drug Profile 50

Product Description 50

Mechanism Of Action 50

R&D Progress 50

ASP-5878 - Drug Profile 52

Product Description 52

Mechanism Of Action 52

R&D Progress 52

AZ-709 - Drug Profile 53

Product Description 53

Mechanism Of Action 53

R&D Progress 53

BLU-554 - Drug Profile 54

Product Description 54

Mechanism Of Action 54

R&D Progress 54

BLU-9931 - Drug Profile 56

Product Description 56

Mechanism Of Action 56

R&D Progress 56

BMS-986036 - Drug Profile 57

Product Description 57

Mechanism Of Action 57

R&D Progress 57

EDP-317 - Drug Profile 58

Product Description 58

Mechanism Of Action 58

R&D Progress 58

erdafitinib - Drug Profile 59

Product Description 59

Mechanism Of Action 59

R&D Progress 59

FGF-401 - Drug Profile 61

Product Description 61

Mechanism Of Action 61

R&D Progress 61

H-3B6527 - Drug Profile 62

Product Description 62

Mechanism Of Action 62

R&D Progress 62

infigratinib - Drug Profile 63

Product Description 63

Mechanism Of Action 63

R&D Progress 63

IONIS-463588 - Drug Profile 65

Product Description 65

Mechanism Of Action 65

R&D Progress 65

lenvatinib mesylate - Drug Profile 66

Product Description 66

Mechanism Of Action 66

R&D Progress 66

LQN-725 - Drug Profile 77

Product Description 77

Mechanism Of Action 77

R&D Progress 77

LY-2874455 - Drug Profile 78

Product Description 78

Mechanism Of Action 78

R&D Progress 78

Monoclonal Antibody to Antagonize FGFR4 for Cancer - Drug Profile 79

Product Description 79

Mechanism Of Action 79

R&D Progress 79

NGM-282 - Drug Profile 80

Product Description 80

Mechanism Of Action 80

R&D Progress 80

PRN-1371 - Drug Profile 82

Product Description 82

Mechanism Of Action 82

R&D Progress 82

Recombinant Protein to Agonize FGFR for Type 2 Diabetes - Drug Profile 83

Product Description 83

Mechanism Of Action 83

R&D Progress 83

Recombinant Proteins to Agonize FGFR for Metabolic Disorders - Drug Profile 84

Product Description 84

Mechanism Of Action 84

R&D Progress 84

Small Molecule to Antagonize FGFR4 for Hepatocellular Carcinoma - Drug Profile 85

Product Description 85

Mechanism Of Action 85

R&D Progress 85

Small Molecules to Antagonize Pan FGFR for Oncology - Drug Profile 86

Product Description 86

Mechanism Of Action 86

R&D Progress 86

U3-1784 - Drug Profile 87

Product Description 87

Mechanism Of Action 87

R&D Progress 87

Fibroblast Growth Factor Receptor 4 (CD334 or FGFR4 or EC

2.7.10.1) - Dormant Projects 88

Fibroblast Growth Factor Receptor 4 (CD334 or FGFR4 or EC

2.7.10.1) - Discontinued Products 89

Fibroblast Growth Factor Receptor 4 (CD334 or FGFR4 or EC

2.7.10.1) - Featured News & Press Releases 90

Jul 04, 2016: Eisai Launches In-House Developed Novel Anticancer Agent Lenvima In Mexico 90

Jun 30, 2016: ArQule Presents Preliminary Clinical Data for ARQ 087 Demonstrating Evidence of Anticancer Activity in Intrahepatic Cholangiocarcinoma at the ESMO 18th World Congress on Gastrointestinal Cancer 90

Jun 23, 2016: ArQule to Present Preliminary Phase 1/2 Data for FGFR Inhibitor, ARQ 087, in Intrahepatic Cholangiocarcinoma at the ESMO 18th World Congress on Gastrointestinal Cancer 91

Jun 06, 2016: Principia Biopharma Announces Presentation of Initial Clinical Data on PRN1371 at 2016 American Society of Clinical Oncology Annual Meeting 91

May 31, 2016: City Of Hope researchers present data on BGJ398 at the American Society of Clinical Oncology’s Annual Meeting 92

May 24, 2016: Eisai To Present on Lenvima at 52nd Annual Meeting of the American Society of Clinical Oncology 92

May 16, 2016: U.S. FDA Approves additional indication for Eisai anti cancer agent LENVIMA in Combination with Everolimus as Treatment for Advanced Renal Cell Carcinoma 93

Apr 20, 2016: Eisai Announces Non-Clinical Research Findings At Aacr 107Th Annual Meeting Regarding Combination Of Anticancer Agent Lenvatinib With Everolimus 94

Apr 12, 2016: Highly Anticipated New Treatment Option Now Available for Canadians with Select Type of Thyroid Cancer 95

Mar 09, 2016: Lenvima (lenvatinib) Now Available in Israel as Important New Treatment for People with Advanced Thyroid Cancer 96

Feb 25, 2016: Eisai Slams the New Cancer Drug Fund that Further Delays Patient Access to New Cancer Drug 97

Jan 18, 2016: U.S. FDA Accepts for Priority Review sNDA for Eisai’S Anticancer Agent Lenvatinib Seeking Approval for Renal Cell Carcinoma 98

Jan 12, 2016: Eisai Submits New Application In Europe For In-House Developed Anticancer Agent Lenvatinib Seeking Approval For Indication Covering Renal Cell Carcinoma 98

Dec 16, 2015: Lenvima (lenvatinib) Now Reimbursed for Advanced Thyroid Cancer in Sweden 100

Dec 15, 2015: ArQule Announces Orphan Drug Designation in Cholangiocarcinoma and Clinical Update for ARQ 087 100

Appendix 102

Methodology 102

Coverage 102

Secondary Research 102

Primary Research 102

Expert Panel Validation 102

Contact Us 102

Disclaimer 103

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 Amgen Inc., H2 2016 30

Pipeline by ArQule, Inc., H2 2016 31

Pipeline by Astellas Pharma Inc., H2 2016 32

Pipeline by AstraZeneca Plc, H2 2016 33

Pipeline by AVEO Pharmaceuticals, Inc., H2 2016 34

Pipeline by Blueprint Medicines Corporation, H2 2016 35

Pipeline by Bristol-Myers Squibb Company, H2 2016 36

Pipeline by Daiichi Sankyo Company, Limited, H2 2016 37

Pipeline by Eddingpharm, H2 2016 38

Pipeline by Eisai Co., Ltd., H2 2016 39

Pipeline by Eli Lilly and Company, H2 2016 41

Pipeline by Genosco, H2 2016 42

Pipeline by H3 Biomedicine Inc., H2 2016 43

Pipeline by Ionis Pharmaceuticals, Inc., H2 2016 44

Pipeline by Johnson & Johnson, H2 2016 45

Pipeline by NGM Biopharmaceuticals, Inc., H2 2016 46

Pipeline by Novartis AG, H2 2016 47

Pipeline by Principia Biopharma Inc., H2 2016 48

Pipeline by Vichem Chemie Research Ltd., H2 2016 49

Dormant Projects, H2 2016 88

Discontinued Products, H2 2016 89

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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