Dual Specificity Mitogen Activated Protein Kinase Kinase 1 (ERK Activator Kinase 1 or MAPK/ERK Kinase 1 or MAP2K1 or EC 2.7.12.2) - Pipeline Review, H2 2016

Global Markets Direct’s, ‘Dual Specificity Mitogen Activated Protein Kinase Kinase 1 (ERK Activator Kinase 1 or MAPK/ERK Kinase 1 or MAP2K1 or EC 2.7.12.2) - Pipeline Review, H2 2016’, provides in depth analysis on Dual Specificity Mitogen Activated Protein Kinase Kinase 1 (ERK Activator Kinase 1 or MAPK/ERK Kinase 1 or MAP2K1 or EC 2.7.12.2) targeted pipeline therapeutics.

The report provides comprehensive information on the Dual Specificity Mitogen Activated Protein Kinase Kinase 1 (ERK Activator Kinase 1 or MAPK/ERK Kinase 1 or MAP2K1 or EC 2.7.12.2) , 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 Dual Specificity Mitogen Activated Protein Kinase Kinase 1 (ERK Activator Kinase 1 or MAPK/ERK Kinase 1 or MAP2K1 or EC 2.7.12.2) 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 Dual Specificity Mitogen Activated Protein Kinase Kinase 1 (ERK Activator Kinase 1 or MAPK/ERK Kinase 1 or MAP2K1 or EC 2.7.12.2)

The report reviews Dual Specificity Mitogen Activated Protein Kinase Kinase 1 (ERK Activator Kinase 1 or MAPK/ERK Kinase 1 or MAP2K1 or EC 2.7.12.2) 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 Dual Specificity Mitogen Activated Protein Kinase Kinase 1 (ERK Activator Kinase 1 or MAPK/ERK Kinase 1 or MAP2K1 or EC 2.7.12.2) targeted therapeutics and enlists all their major and minor projects

The report assesses Dual Specificity Mitogen Activated Protein Kinase Kinase 1 (ERK Activator Kinase 1 or MAPK/ERK Kinase 1 or MAP2K1 or EC 2.7.12.2) 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 Dual Specificity Mitogen Activated Protein Kinase Kinase 1 (ERK Activator Kinase 1 or MAPK/ERK Kinase 1 or MAP2K1 or EC 2.7.12.2) 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 Dual Specificity Mitogen Activated Protein Kinase Kinase 1 (ERK Activator Kinase 1 or MAPK/ERK Kinase 1 or MAP2K1 or EC 2.7.12.2)

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 Dual Specificity Mitogen Activated Protein Kinase Kinase 1 (ERK Activator Kinase 1 or MAPK/ERK Kinase 1 or MAP2K1 or EC 2.7.12.2) 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.

AstraZeneca Plc

Eisai Co., Ltd.

F. Hoffmann-La Roche Ltd.

GlaxoSmithKline Plc

Merck & Co., Inc.

Merck KGaA

Novartis AG

Array BioPharma Inc.

AstraZeneca Plc

Eisai Co., Ltd.

F. Hoffmann-La Roche Ltd.

GlaxoSmithKline Plc

Merck & Co., Inc.

Merck KGaA

Novartis AG

Table of Contents

Table of Contents

Table of Contents 2

List of Tables 5

List of Figures 6

Introduction 7

Global Markets Direct Report Coverage 7

Dual Specificity ...

Table of Contents

Table of Contents 2

List of Tables 5

List of Figures 6

Introduction 7

Global Markets Direct Report Coverage 7

Dual Specificity Mitogen Activated Protein Kinase Kinase 1 (ERK Activator Kinase 1 or MAPK/ERK Kinase 1 or MAP2K1 or EC 2.7.12.2) Overview 8

Therapeutics Development 9

Dual Specificity Mitogen Activated Protein Kinase Kinase 1 (ERK Activator Kinase 1 or MAPK/ERK Kinase 1 or MAP2K1 or EC 2.7.12.2) - Products under Development by Stage of Development 9

Dual Specificity Mitogen Activated Protein Kinase Kinase 1 (ERK Activator Kinase 1 or MAPK/ERK Kinase 1 or MAP2K1 or EC 2.7.12.2) - Products under Development by Therapy Area 10

Dual Specificity Mitogen Activated Protein Kinase Kinase 1 (ERK Activator Kinase 1 or MAPK/ERK Kinase 1 or MAP2K1 or EC 2.7.12.2) - Products under Development by Indication 11

Dual Specificity Mitogen Activated Protein Kinase Kinase 1 (ERK Activator Kinase 1 or MAPK/ERK Kinase 1 or MAP2K1 or EC 2.7.12.2) - Pipeline Products Glance 13

Late Stage Products 13

Early Stage Products 14

Dual Specificity Mitogen Activated Protein Kinase Kinase 1 (ERK Activator Kinase 1 or MAPK/ERK Kinase 1 or MAP2K1 or EC 2.7.12.2) - Products under Development by Companies 15

Dual Specificity Mitogen Activated Protein Kinase Kinase 1 (ERK Activator Kinase 1 or MAPK/ERK Kinase 1 or MAP2K1 or EC 2.7.12.2) - Therapeutics Assessment 21

Assessment by Monotherapy/Combination Products 21

Assessment by Mechanism of Action 22

Assessment by Route of Administration 23

Assessment by Molecule Type 25

Dual Specificity Mitogen Activated Protein Kinase Kinase 1 (ERK Activator Kinase 1 or MAPK/ERK Kinase 1 or MAP2K1 or EC 2.7.12.2) - Companies Involved in Therapeutics Development 27

Array BioPharma Inc. 27

AstraZeneca Plc 28

Eisai Co., Ltd. 29

F. Hoffmann-La Roche Ltd. 30

GlaxoSmithKline Plc 31

Merck & Co., Inc. 32

Merck KGaA 33

Novartis AG 34

Dual Specificity Mitogen Activated Protein Kinase Kinase 1 (ERK Activator Kinase 1 or MAPK/ERK Kinase 1 or MAP2K1 or EC 2.7.12.2) - Drug Profiles 36

binimetinib - Drug Profile 36

Product Description 36

Mechanism Of Action 36

R&D Progress 36

binimetinib + encorafenib - Drug Profile 43

Product Description 43

Mechanism Of Action 43

R&D Progress 43

CIP-137401 - Drug Profile 45

Product Description 45

Mechanism Of Action 45

R&D Progress 45

cobimetinib fumarate - Drug Profile 46

Product Description 46

Mechanism Of Action 46

R&D Progress 46

dabrafenib mesylate + durvalumab + trametinib dimethyl sulfoxide - Drug Profile 52

Product Description 52

Mechanism Of Action 52

R&D Progress 52

dabrafenib mesylate + panitumumab + trametinib dimethyl sulfoxide - Drug Profile 53

Product Description 53

Mechanism Of Action 53

R&D Progress 53

dabrafenib mesylate + trametinib dimethyl sulfoxide - Drug Profile 54

Product Description 54

Mechanism Of Action 54

R&D Progress 54

E-6201 - Drug Profile 61

Product Description 61

Mechanism Of Action 61

R&D Progress 61

EBI-1051 - Drug Profile 63

Product Description 63

Mechanism Of Action 63

R&D Progress 63

MK-2206 + selumetinib sulfate - Drug Profile 64

Product Description 64

Mechanism Of Action 64

R&D Progress 64

pimasertib hydrochloride - Drug Profile 65

Product Description 65

Mechanism Of Action 65

R&D Progress 65

pimasertib hydrochloride + voxtalisib - Drug Profile 68

Product Description 68

Mechanism Of Action 68

R&D Progress 68

RG-7304 - Drug Profile 70

Product Description 70

Mechanism Of Action 70

R&D Progress 70

selumetinib sulfate - Drug Profile 71

Product Description 71

Mechanism Of Action 71

R&D Progress 71

trametinib dimethyl sulfoxide - Drug Profile 76

Product Description 76

Mechanism Of Action 76

R&D Progress 76

trametinib dimethyl sulfoxide + uprosertib - Drug Profile 81

Product Description 81

Mechanism Of Action 81

R&D Progress 81

Dual Specificity Mitogen Activated Protein Kinase Kinase 1 (ERK Activator Kinase 1 or MAPK/ERK Kinase 1 or MAP2K1 or EC 2.7.12.2) - Dormant Projects 83

Dual Specificity Mitogen Activated Protein Kinase Kinase 1 (ERK Activator Kinase 1 or MAPK/ERK Kinase 1 or MAP2K1 or EC 2.7.12.2) - Discontinued Products 91

Dual Specificity Mitogen Activated Protein Kinase Kinase 1 (ERK Activator Kinase 1 or MAPK/ERK Kinase 1 or MAP2K1 or EC 2.7.12.2) - Featured News & Press Releases 93

Jun 30, 2016: Array BioPharma Submits Binimetinib New Drug Application to U.S. FDA 93

Jun 06, 2016: Array Presents Full Results from Phase 3 NEMO Study 94

Jun 06, 2016: Novartis combination therapy Tafinlar + Mekinist demonstrates overall survival benefit at three-year follow-up in patients with advanced melanoma 95

Jun 06, 2016: Novartis pivotal data for Tafinlar + Mekinist demonstrated a 63 percent overall response rate in treating rare form of lung cancer 96

Jun 05, 2016: Exelixis Announces Genentech Presentation of Preliminary Phase 1B Trial Results for the Combination of Cobimetinib and Atezolizumab at ASCO 2016 Annual Meeting 97

Jun 03, 2016: Cobimetinib in advanced melanoma with BRAF V600 mutation: Added benefit now considerable 98

May 18, 2016: Array BioPharma Announces Key Data from NRAS-mutant Melanoma at ASCO 2016 99

May 12, 2016: Selumetinib granted Orphan Drug Designation in the US for adjuvant treatment of differentiated thyroid cancer 100

Apr 29, 2016: NICE recommends combined drug therapy proven to extend life for skin cancer 101

Apr 20, 2016: Exelixis Announces Presentation On Cobimetinib At 2016 ASCO Annual Meeting 101

Apr 01, 2016: Array BioPharma Announces Decision To Discontinue MILO Study In Ovarian Cancer 103

Mar 22, 2016: Many Targeted Cancer Therapies Suppress T Cell Immune Responses 103

Feb 25, 2016: New targeted therapy for treatment of serious form of skin cancer approved in Canada 104

Jan 13, 2016: Dabrafenib/trametinib in advanced BRAF V600 mutated melanoma: Indication of added benefit 106

Dec 16, 2015: Array BioPharma Announces Phase 3 Binimetinib Trial Meets Primary Endpoint For NRAS-Mutant Melanoma 107

Appendix 109

Methodology 109

Coverage 109

Secondary Research 109

Primary Research 109

Expert Panel Validation 109

Contact Us 109

Disclaimer 110

List of Tables

List of Tables

Number of Products under Development for, H2 2016 9

Number of Products under Development by Therapy Area, H2 2016 10

Number of ...

List of Tables

Number of Products under Development for, H2 2016 9

Number of Products under Development by Therapy Area, H2 2016 10

Number of Products under Development by Indication, H2 2016 11

Comparative Analysis by Late Stage Development, H2 2016 13

Comparative Analysis by Early Stage Products, H2 2016 14

Number of Products under Development by Companies, H2 2016 15

Products under Development by Companies, H2 2016 16

Products under Development by Companies, H2 2016 (Contd..1) 17

Products under Development by Companies, H2 2016 (Contd..2) 18

Products under Development by Companies, H2 2016 (Contd..3) 19

Products under Development by Companies, H2 2016 (Contd..4) 20

Assessment by Monotherapy/Combination Products, H2 2016 21

Number of Products by Stage and Mechanism of Action, H2 2016 22

Number of Products by Stage and Route of Administration, H2 2016 24

Number of Products by Stage and Molecule Type, H2 2016 26

Pipeline by Array BioPharma Inc., H2 2016 27

Pipeline by AstraZeneca Plc, H2 2016 28

Pipeline by Eisai Co., Ltd., H2 2016 29

Pipeline by F. Hoffmann-La Roche Ltd., H2 2016 30

Pipeline by GlaxoSmithKline Plc, H2 2016 31

Pipeline by Merck & Co., Inc., H2 2016 32

Pipeline by Merck KGaA, H2 2016 33

Pipeline by Novartis AG, H2 2016 34

Dormant Projects, H2 2016 83

Dormant Projects (Contd..1), H2 2016 84

Dormant Projects (Contd..2), H2 2016 85

Dormant Projects (Contd..3), H2 2016 86

Dormant Projects (Contd..4), H2 2016 87

Dormant Projects (Contd..5), H2 2016 88

Dormant Projects (Contd..6), H2 2016 89

Dormant Projects (Contd..7), H2 2016 90

Discontinued Products, H2 2016 91

Discontinued Products (Contd..1), H2 2016 92

List of Figures

List of Figures

Number of Products under Development for, H2 2016 9

Number of Products under Development by Therapy Area, H2 2016 10

Number of ...

List of Figures

Number of Products under Development for, H2 2016 9

Number of Products under Development by Therapy Area, H2 2016 10

Number of Products under Development by Top 10 Indication, H2 2016 11

Comparative Analysis by Late Stage Development, H2 2016 13

Comparative Analysis by Early Stage Products, H2 2016 14

Assessment by Monotherapy/Combination Products, H2 2016 21

Number of Products by Stage and Mechanism of Actions, H2 2016 22

Number of Products by Routes of Administration, H2 2016 23

Number of Products by Stage and Routes of Administration, H2 2016 23

Number of Products by Molecule Types, H2 2016 25

Number of Products by Stage and Molecule Type, H2 2016 25

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