Dual Specificity Mitogen Activated Protein Kinase Kinase 2 (ERK Activator Kinase 2 or MAPK/ERK Kinase 2 or MAP2K2 or EC 2.7.12.2) - Pipeline Review, H2 2016

Global Markets Direct’s, ‘Dual Specificity Mitogen Activated Protein Kinase Kinase 2 (ERK Activator Kinase 2 or MAPK/ERK Kinase 2 or MAP2K2 or EC 2.7.12.2) - Pipeline Review, H2 2016’, provides in depth analysis on Dual Specificity Mitogen Activated Protein Kinase Kinase 2 (ERK Activator Kinase 2 or MAPK/ERK Kinase 2 or MAP2K2 or EC 2.7.12.2) targeted pipeline therapeutics.

The report provides comprehensive information on the Dual Specificity Mitogen Activated Protein Kinase Kinase 2 (ERK Activator Kinase 2 or MAPK/ERK Kinase 2 or MAP2K2 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 2 (ERK Activator Kinase 2 or MAPK/ERK Kinase 2 or MAP2K2 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 2 (ERK Activator Kinase 2 or MAPK/ERK Kinase 2 or MAP2K2 or EC 2.7.12.2)

The report reviews Dual Specificity Mitogen Activated Protein Kinase Kinase 2 (ERK Activator Kinase 2 or MAPK/ERK Kinase 2 or MAP2K2 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 2 (ERK Activator Kinase 2 or MAPK/ERK Kinase 2 or MAP2K2 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 2 (ERK Activator Kinase 2 or MAPK/ERK Kinase 2 or MAP2K2 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 2 (ERK Activator Kinase 2 or MAPK/ERK Kinase 2 or MAP2K2 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 2 (ERK Activator Kinase 2 or MAPK/ERK Kinase 2 or MAP2K2 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 2 (ERK Activator Kinase 2 or MAPK/ERK Kinase 2 or MAP2K2 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

Confluence Life Sciences, Inc.

F. Hoffmann-La Roche Ltd.

GlaxoSmithKline Plc

Merck & Co., Inc.

Merck KGaA

Novartis AG

Array BioPharma Inc.

AstraZeneca Plc

Confluence Life Sciences, Inc.

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 2 (ERK Activator Kinase 2 or MAPK/ERK Kinase 2 or MAP2K2 or EC 2.7.12.2) Overview 8

Therapeutics Development 9

Dual Specificity Mitogen Activated Protein Kinase Kinase 2 (ERK Activator Kinase 2 or MAPK/ERK Kinase 2 or MAP2K2 or EC 2.7.12.2) - Products under Development by Stage of Development 9

Dual Specificity Mitogen Activated Protein Kinase Kinase 2 (ERK Activator Kinase 2 or MAPK/ERK Kinase 2 or MAP2K2 or EC 2.7.12.2) - Products under Development by Therapy Area 10

Dual Specificity Mitogen Activated Protein Kinase Kinase 2 (ERK Activator Kinase 2 or MAPK/ERK Kinase 2 or MAP2K2 or EC 2.7.12.2) - Products under Development by Indication 11

Dual Specificity Mitogen Activated Protein Kinase Kinase 2 (ERK Activator Kinase 2 or MAPK/ERK Kinase 2 or MAP2K2 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 2 (ERK Activator Kinase 2 or MAPK/ERK Kinase 2 or MAP2K2 or EC 2.7.12.2) - Products under Development by Companies 15

Dual Specificity Mitogen Activated Protein Kinase Kinase 2 (ERK Activator Kinase 2 or MAPK/ERK Kinase 2 or MAP2K2 or EC 2.7.12.2) - Therapeutics Assessment 20

Assessment by Monotherapy/Combination Products 20

Assessment by Mechanism of Action 21

Assessment by Route of Administration 22

Assessment by Molecule Type 24

Dual Specificity Mitogen Activated Protein Kinase Kinase 2 (ERK Activator Kinase 2 or MAPK/ERK Kinase 2 or MAP2K2 or EC 2.7.12.2) - Companies Involved in Therapeutics Development 26

Array BioPharma Inc. 26

AstraZeneca Plc 27

Confluence Life Sciences, Inc. 28

F. Hoffmann-La Roche Ltd. 29

GlaxoSmithKline Plc 30

Merck & Co., Inc. 31

Merck KGaA 32

Novartis AG 33

Dual Specificity Mitogen Activated Protein Kinase Kinase 2 (ERK Activator Kinase 2 or MAPK/ERK Kinase 2 or MAP2K2 or EC 2.7.12.2) - Drug Profiles 35

binimetinib - Drug Profile 35

Product Description 35

Mechanism Of Action 35

R&D Progress 35

binimetinib + encorafenib - Drug Profile 42

Product Description 42

Mechanism Of Action 42

R&D Progress 42

CDD-450 - Drug Profile 44

Product Description 44

Mechanism Of Action 44

R&D Progress 44

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

MK-2206 + selumetinib sulfate - Drug Profile 61

Product Description 61

Mechanism Of Action 61

R&D Progress 61

pimasertib hydrochloride - Drug Profile 62

Product Description 62

Mechanism Of Action 62

R&D Progress 62

pimasertib hydrochloride + voxtalisib - Drug Profile 65

Product Description 65

Mechanism Of Action 65

R&D Progress 65

selumetinib sulfate - Drug Profile 67

Product Description 67

Mechanism Of Action 67

R&D Progress 67

trametinib dimethyl sulfoxide - Drug Profile 72

Product Description 72

Mechanism Of Action 72

R&D Progress 72

trametinib dimethyl sulfoxide + uprosertib - Drug Profile 77

Product Description 77

Mechanism Of Action 77

R&D Progress 77

Dual Specificity Mitogen Activated Protein Kinase Kinase 2 (ERK Activator Kinase 2 or MAPK/ERK Kinase 2 or MAP2K2 or EC 2.7.12.2) - Dormant Projects 79

Dual Specificity Mitogen Activated Protein Kinase Kinase 2 (ERK Activator Kinase 2 or MAPK/ERK Kinase 2 or MAP2K2 or EC 2.7.12.2) - Discontinued Products 87

Dual Specificity Mitogen Activated Protein Kinase Kinase 2 (ERK Activator Kinase 2 or MAPK/ERK Kinase 2 or MAP2K2 or EC 2.7.12.2) - Featured News & Press Releases 89

Jun 30, 2016: Array BioPharma Submits Binimetinib New Drug Application to U.S. FDA 89

Jun 06, 2016: Array Presents Full Results from Phase 3 NEMO Study 90

Jun 06, 2016: Novartis combination therapy Tafinlar + Mekinist demonstrates overall survival benefit at three-year follow-up in patients with advanced melanoma 91

Jun 06, 2016: Novartis pivotal data for Tafinlar + Mekinist demonstrated a 63 percent overall response rate in treating rare form of lung cancer 92

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 93

Jun 03, 2016: Cobimetinib in advanced melanoma with BRAF V600 mutation: Added benefit now considerable 94

May 18, 2016: Array BioPharma Announces Key Data from NRAS-mutant Melanoma at ASCO 2016 95

May 12, 2016: Selumetinib granted Orphan Drug Designation in the US for adjuvant treatment of differentiated thyroid cancer 96

Apr 29, 2016: NICE recommends combined drug therapy proven to extend life for skin cancer 97

Apr 20, 2016: Exelixis Announces Presentation On Cobimetinib At 2016 ASCO Annual Meeting 97

Apr 01, 2016: Array BioPharma Announces Decision To Discontinue MILO Study In Ovarian Cancer 99

Mar 22, 2016: Many Targeted Cancer Therapies Suppress T Cell Immune Responses 99

Feb 25, 2016: New targeted therapy for treatment of serious form of skin cancer approved in Canada 100

Jan 13, 2016: Dabrafenib/trametinib in advanced BRAF V600 mutated melanoma: Indication of added benefit 102

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

Assessment by Monotherapy/Combination Products, H2 2016 20

Number of Products by Stage and Mechanism of Action, H2 2016 21

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

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

Pipeline by Array BioPharma Inc., H2 2016 26

Pipeline by AstraZeneca Plc, H2 2016 27

Pipeline by Confluence Life Sciences, Inc., H2 2016 28

Pipeline by F. Hoffmann-La Roche Ltd., H2 2016 29

Pipeline by GlaxoSmithKline Plc, H2 2016 30

Pipeline by Merck & Co., Inc., H2 2016 31

Pipeline by Merck KGaA, H2 2016 32

Pipeline by Novartis AG, H2 2016 33

Dormant Projects, H2 2016 79

Dormant Projects (Contd..1), H2 2016 80

Dormant Projects (Contd..2), H2 2016 81

Dormant Projects (Contd..3), H2 2016 82

Dormant Projects (Contd..4), H2 2016 83

Dormant Projects (Contd..5), H2 2016 84

Dormant Projects (Contd..6), H2 2016 85

Dormant Projects (Contd..7), H2 2016 86

Discontinued Products, H2 2016 87

Discontinued Products (Contd..1), H2 2016 88

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 20

Number of Products by Stage and Mechanism of Actions, H2 2016 21

Number of Products by Routes of Administration, H2 2016 22

Number of Products by Stage and Routes of Administration, H2 2016 22

Number of Products by Molecule Types, H2 2016 24

Number of Products by Stage and Molecule Type, H2 2016 24

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