Systemic Mastocytosis – Pipeline Review, H2 2016

Global Markets Direct’s, ‘Systemic Mastocytosis – Pipeline Review, H2 2016’, provides an overview of the Systemic Mastocytosis pipeline landscape.

The report provides comprehensive information on the therapeutics under development for Systemic Mastocytosis, complete with analysis by stage of development, drug target, 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 therapeutic development for Systemic Mastocytosis 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 of Systemic Mastocytosis

The report reviews pipeline therapeutics for Systemic Mastocytosis 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 Systemic Mastocytosis therapeutics and enlists all their major and minor projects

The report assesses Systemic Mastocytosis therapeutics based on drug target, 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 related to pipeline therapeutics for Systemic Mastocytosis

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 important and diverse types of therapeutics under development for Systemic Mastocytosis

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 Systemic Mastocytosis pipeline depth and focus of Indication therapeutics

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

Modify the therapeutic portfolio by identifying discontinued projects and understanding the factors that drove them from pipeline

Companies mentioned

AB Science SA

AbbVie Inc

Allakos Inc.

Arog Pharmaceuticals, Inc.

Blueprint Medicines Corporation

Bristol-Myers Squibb Company

Deciphera Pharmaceuticals, LLC

Novartis AG

Patara Pharma Inc

Stemline Therapeutics, Inc.

Table of Contents

Table of Contents

Table of Contents 2

List of Tables 5

List of Figures 5

Introduction 6

Global Markets Direct Report Coverage 6

Systemic Mastocytosis Overview 7

Therapeutics Development 8

Pipeline Products for Systemic Mastocytosis - Overview 8

Systemic Mastocytosis - Therapeutics under Development by Companies 9

Systemic Mastocytosis - Pipeline Products Glance 10

Late Stage Products 10

Clinical Stage Products 11

Early Stage Products 12

Systemic Mastocytosis - Products under Development by Companies 13

Systemic Mastocytosis - Companies Involved in Therapeutics Development 14

AB Science SA 14

AbbVie Inc 15

Allakos Inc. 16

Arog Pharmaceuticals, Inc. 17

Blueprint Medicines Corporation 18

Bristol-Myers Squibb Company 19

Deciphera Pharmaceuticals, LLC 20

Novartis AG 21

Patara Pharma Inc 22

Stemline Therapeutics, Inc. 23

Systemic Mastocytosis - Therapeutics Assessment 24

Assessment by Monotherapy Products 24

Assessment by Target 25

Assessment by Mechanism of Action 27

Assessment by Route of Administration 29

Assessment by Molecule Type 31

Drug Profiles 33

AK-002 - Drug Profile 33

Product Description 33

Mechanism Of Action 33

R&D Progress 33

BLU-285 - Drug Profile 34

Product Description 34

Mechanism Of Action 34

R&D Progress 34

crenolanib besylate - Drug Profile 36

Product Description 36

Mechanism Of Action 36

R&D Progress 36

cromolyn sodium - Drug Profile 39

Product Description 39

Mechanism Of Action 39

R&D Progress 39

dasatinib - Drug Profile 40

Product Description 40

Mechanism Of Action 40

R&D Progress 40

DCC-2618 - Drug Profile 43

Product Description 43

Mechanism Of Action 43

R&D Progress 43

ibrutinib - Drug Profile 44

Product Description 44

Mechanism Of Action 44

R&D Progress 44

masitinib - Drug Profile 70

Product Description 70

Mechanism Of Action 70

R&D Progress 70

midostaurin - Drug Profile 84

Product Description 84

Mechanism Of Action 84

R&D Progress 84

SL-401 - Drug Profile 86

Product Description 86

Mechanism Of Action 86

R&D Progress 86

Systemic Mastocytosis - Discontinued Products 92

Systemic Mastocytosis - Product Development Milestones 93

Featured News & Press Releases 93

Nov 03, 2016: Blueprint Medicines to Present Preliminary Data from Ongoing Phase 1 Clinical Trial for BLU-285 in Advanced Systemic Mastocytosis at 2016 ASH Annual Meeting 93

Oct 31, 2016: Deciphera Pharmaceuticals to Present Clinical Data on DCC-2618 at 28th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics 93

Oct 28, 2016: Blueprint Medicines to Present Preclinical Data and Provide Enrollment Updates for Phase 1 Clinical Trial for BLU-285 in Advanced Systemic Mastocytosis at ECNM Annual Meeting 2016 94

Sep 15, 2016: Allakos Begins Clinical Trials of AK002 in Patients with Systemic Mastocytosis 95

Jun 29, 2016: Novartis PKC412 (midostaurin) pivotal data published in NEJM show 60% response rate in advanced systemic mastocytosis (SM) 95

May 30, 2016: AB Science will Present Phase 3 Data in Severe Systemic Mastocytosis at the International 21St Congress of the European Hematology Association 95

May 02, 2016: AB Science has submitted to EMA the marketing authorization application for Masitinib in the Treatment of Severe Systemic Mastocytosis 97

Feb 01, 2016: AB Science announces that Rapporteurs appointed by the EMA have recommended to file a marketing authorization application for full approval for masitinib in severe systemic mastocytosis 97

Dec 07, 2015: AB Science announces results from Phase 3 randomized placebo-controlled trial of masitinib in adults with severe systemic mastocytosis unresponsive to optimal symptomatic treatment 100

Nov 30, 2015: AB Science Announces Positive Top-Line Results from Phase 3 Trial of Masitinib in Adults with Severe Systemic Mastocytosis 102

Sep 10, 2015: Blueprint Medicines Receives FDA Authorization to Advance Novel Drug Candidate into Clinical Trial for Systemic Mastocytosis 103

Dec 08, 2014: Blueprint Medicines Debuts Comprehensive Preclinical Data Set on First Selective Drug for Patients with Systemic Mastocytosis at 2014 American Society of Hematology Annual Meeting 104

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 Systemic Mastocytosis, H2 2016 8

Number of Products under Development by Companies, H2 2016 9

Comparative Analysis by Late Stage Development, H2 2016 10

Comparative Analysis by Clinical Stage Development, H2 2016 11

Comparative Analysis by Early Stage Development, H2 2016 12

Products under Development by Companies, H2 2016 13

Systemic Mastocytosis – Pipeline by AB Science SA, H2 2016 14

Systemic Mastocytosis – Pipeline by AbbVie Inc, H2 2016 15

Systemic Mastocytosis – Pipeline by Allakos Inc., H2 2016 16

Systemic Mastocytosis – Pipeline by Arog Pharmaceuticals, Inc., H2 2016 17

Systemic Mastocytosis – Pipeline by Blueprint Medicines Corporation, H2 2016 18

Systemic Mastocytosis – Pipeline by Bristol-Myers Squibb Company, H2 2016 19

Systemic Mastocytosis – Pipeline by Deciphera Pharmaceuticals, LLC, H2 2016 20

Systemic Mastocytosis – Pipeline by Novartis AG, H2 2016 21

Systemic Mastocytosis – Pipeline by Patara Pharma Inc, H2 2016 22

Systemic Mastocytosis – Pipeline by Stemline Therapeutics, Inc., H2 2016 23

Assessment by Monotherapy Products, H2 2016 24

Number of Products by Stage and Target, H2 2016 26

Number of Products by Stage and Mechanism of Action, H2 2016 28

Number of Products by Stage and Route of Administration, H2 2016 30

Number of Products by Stage and Molecule Type, H2 2016 32

Systemic Mastocytosis – Discontinued Products, H2 2016 92

List of Figures

List of Figures

Number of Products under Development for Systemic Mastocytosis, H2 2016 8

Number of Products under Development by Companies, H2 2016 9

Comparative Analysis by Clinical Stage Development, H2 2016 11

Assessment by Monotherapy Products, H2 2016 24

Number of Products by Top 10 Targets, H2 2016 25

Number of Products by Stage and Top 10 Targets, H2 2016 25

Number of Products by Top 10 Mechanism of Actions, H2 2016 27

Number of Products by Stage and Top 10 Mechanism of Actions, H2 2016 27

Number of Products by Routes of Administration, H2 2016 29

Number of Products by Stage and Routes of Administration, H2 2016 29

Number of Products by Molecule Types, H2 2016 31

Number of Products by Stage and Molecule Types, H2 2016 31

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