Waldenstrom Macroglobulinemia-Pipeline Review, H1 2015

Waldenstrom Macroglobulinemia-Pipeline Review, H1 2015

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Executive Summary

Waldenstrom Macroglobulinemia-Pipeline Review, H1 2015


Global Markets Direct's, 'Waldenstrom Macroglobulinemia-Pipeline Review, H1 2015', provides an overview of the Waldenstrom Macroglobulinemia's therapeutic pipeline.

This report provides comprehensive information on the therapeutic development for Waldenstrom Macroglobulinemia, complete with comparative analysis at various stages, therapeutics assessment by drug target, mechanism of action (MoA), route of administration (RoA) and molecule type, along with latest updates, and featured news and press releases. It also reviews key players involved in the therapeutic development for Waldenstrom Macroglobulinemia and special features on late-stage 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, SEC filings, investor presentations and featured press releases from company/university sites and industry-specific third party sources, put together by Global Markets Direct's team. Drug profiles/records featured in the report undergoes periodic updation following a stringent set of processes that ensures that all the profiles are updated with the latest set of information. Additionally, processes including live news & deals tracking, browser based alert-box and clinical trials registries tracking ensure that the most recent developments are captured on a real time basis.

The report enhances decision making capabilities and help to create effective counter strategies to gain competitive advantage. It strengthens R&D pipelines by identifying new targets and MOAs to produce first-in-class and best-in-class products.

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


The report provides a snapshot of the global therapeutic landscape of Waldenstrom Macroglobulinemia

The report reviews key pipeline products under drug profile section which includes, product description, MoA and R&D brief, licensing and collaboration details & other developmental activities

The report reviews key players involved in the therapeutics development for Waldenstrom Macroglobulinemia and enlists all their major and minor projects

The report summarizes all the dormant and discontinued pipeline projects

A review of the Waldenstrom Macroglobulinemia products under development by companies and universities/research institutes based on information derived from company and industry-specific sources

Pipeline products coverage based on various stages of development ranging from pre-registration till discovery and undisclosed stages

A detailed assessment of monotherapy and combination therapy pipeline projects

Coverage of the Waldenstrom Macroglobulinemia pipeline on the basis of target, MoA, route of administration and molecule type

Latest news and deals relating related to pipeline products

Reasons To Buy

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

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

Develop strategic initiatives by understanding the focus areas of leading companies

Identify and understand important and diverse types of therapeutics under development for Waldenstrom Macroglobulinemia

Plan mergers and acquisitions effectively by identifying key players of the most promising pipeline

Devise corrective measures for pipeline projects by understanding Waldenstrom Macroglobulinemia 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

Read More

Contact Us:
Ken Research
Ankur Gupta, Head Marketing & Communications


Table of Contents

Table of Contents 2

List of Tables 6

List of Figures 7

Introduction 8

Global Markets Direct Report Coverage 8

Waldenstrom Macroglobulinemia Overview 9

Therapeutics Development 10

Pipeline Products for Waldenstrom Macroglobulinemia-Overview 10

Pipeline Products for Waldenstrom Macroglobulinemia-Comparative Analysis 11

Waldenstrom Macroglobulinemia-Therapeutics under Development by Companies 12

Waldenstrom Macroglobulinemia-Pipeline Products Glance 14

Late Stage Products 14

Clinical Stage Products 15

Early Stage Products 16

Waldenstrom Macroglobulinemia-Products under Development by Companies 17

Waldenstrom Macroglobulinemia-Companies Involved in Therapeutics Development 19

AbbVie Inc. 19

arGEN-X BV 20

Bayer AG 21

Calithera Biosciences, Inc. 22

Celgene Corporation 23

Genmab A/S 24

Gilead Sciences, Inc. 25

Idera Pharmaceuticals, Inc. 26

Immune System Therapeutics Ltd. 27

Incyte Corporation 28

Karyopharm Therapeutics, Inc. 29

Merck KGaA 30

Millennium Pharmaceuticals, Inc. 31

Nimbus Therapeutics, LLC 32

Nordic Nanovector AS 33

Novartis AG 34

Onyx Pharmaceuticals, Inc. 35

Pharmacyclics, Inc. 36

Waldenstrom Macroglobulinemia-Therapeutics Assessment 37

Assessment by Monotherapy Products 37

Assessment by Target 38

Assessment by Mechanism of Action 40

Assessment by Route of Administration 42

Assessment by Molecule Type 44

Drug Profiles 46

ACP-196-Drug Profile 46

Product Description 46

Mechanism of Action 46

R&D Progress 46

ARGX-110-Drug Profile 48

Product Description 48

Mechanism of Action 48

R&D Progress 48

Betalutin-Drug Profile 51

Product Description 51

Mechanism of Action 51

R&D Progress 51

carfilzomib-Drug Profile 53

Product Description 53

Mechanism of Action 53

R&D Progress 53

CB-839-Drug Profile 57

Product Description 57

Mechanism of Action 57

R&D Progress 57

copanlisib-Drug Profile 58

Product Description 58

Mechanism of Action 58

R&D Progress 58

DI-B4-Drug Profile 61

Product Description 61

Mechanism of Action 61

R&D Progress 61

everolimus-Drug Profile 62

Product Description 62

Mechanism of Action 62

R&D Progress 62

FV-162-Drug Profile 67

Product Description 67

Mechanism of Action 67

R&D Progress 67

FV-214-Drug Profile 68

Product Description 68

Mechanism of Action 68

R&D Progress 68

GS-9973-Drug Profile 69

Product Description 69

Mechanism of Action 69

R&D Progress 69

ibrutinib-Drug Profile 70

Product Description 70

Mechanism of Action 70

R&D Progress 70

idelalisib-Drug Profile 76

Product Description 76

Mechanism of Action 76

R&D Progress 76

IMO-8400-Drug Profile 79

Product Description 79

Mechanism of Action 79

R&D Progress 79

INCB-39110-Drug Profile 81

Product Description 81

Mechanism of Action 81

R&D Progress 81

INCB-40093-Drug Profile 83

Product Description 83

Mechanism of Action 83

R&D Progress 83

IST-1097-Drug Profile 84

Product Description 84

Mechanism of Action 84

R&D Progress 84

ixazomib citrate-Drug Profile 85

Product Description 85

Mechanism of Action 85

R&D Progress 85

lenalidomide-Drug Profile 89

Product Description 89

Mechanism of Action 89

R&D Progress 89

ofatumumab-Drug Profile 93

Product Description 93

Mechanism of Action 93

R&D Progress 93

oprozomib-Drug Profile 98

Product Description 98

Mechanism of Action 98

R&D Progress 98

pevonedistat hydrochloride-Drug Profile 100

Product Description 100

Mechanism of Action 100

R&D Progress 100

sapanisertib-Drug Profile 102

Product Description 102

Mechanism of Action 102

R&D Progress 102

selinexor-Drug Profile 104

Product Description 104

Mechanism of Action 104

R&D Progress 104

Small Molecules to Inhibit IRAK4 for Immunology and Oncology-Drug Profile 109

Product Description 109

Mechanism of Action 109

R&D Progress 109

spebrutinib besylate-Drug Profile 110

Product Description 110

Mechanism of Action 110

R&D Progress 110

venetoclax-Drug Profile 112

Product Description 112

Mechanism of Action 112

R&D Progress 112

Waldenstrom Macroglobulinemia-Recent Pipeline Updates 115

Waldenstrom Macroglobulinemia-Dormant Projects 188

Waldenstrom Macroglobulinemia-Dormant Projects 188

Waldenstrom Macroglobulinemia-Discontinued Products 189

Waldenstrom Macroglobulinemia-Product Development Milestones 190

Featured News & Press Releases 190

Apr 09, 2015: New Longer-Term IMBRUVICA (ibrutinib) Data Show High Response Rates in Patients with Waldenstrom's Macroglobulinemia 190

Jan 29, 2015: U.S. FDA Approves IMBRUVICA (ibrutinib) for the Treatment of Waldenstrom's Macroglobulinemia: First FDA-Approved Therapy for This Disease 191

Dec 22, 2014: Pharmacyclics Announces Update on IMBRUVICA (ibrutinib) Waldenstrom's macroglobulinemia Submission 192

Dec 01, 2014: New IMBRUVICA (ibrutinib) Application Accepted by European Medicines Agency for Waldenstrom's Macroglobulinemia 192

Nov 03, 2014: arGEN-X Submits Investigational New Drug Application to Evaluate ARGX-110 in Waldenstrm's Macroglobulinemia 193

Oct 20, 2014: IMBRUVICA (ibrutinib) Supplemental New Drug Application Submitted to the U.S. FDA for Waldenstrom's macroglobulinemia 193

Jun 10, 2014: arGEN-X and the Leukemia & Lymphoma Society Partner on the Development of ARGX-110 for the Treatment of Waldenstrm's Macroglobulinemia 194

Nov 07, 2013: Amgen and Onyx Pharmaceuticals Announce Upcoming Data Presentations On Oprozomib at 55th American Society of Hematology Annual Meeting 195

Jun 20, 2013: Pharmacyclics Presents Ibrutinib Monotherapy Clinical Trial Data In Patients With Waldenstrom's Macroglobulinemia At ICML 195

Apr 01, 2013: Onyx Pharma To Present Data On Oprozomib At 14th International Myeloma Workshop 196

Appendix 198

Methodology 198

Coverage 198

Secondary Research 198

Primary Research 198

Expert Panel Validation 198

Contact Us 198

Disclaimer 199

List of Tables

Number of Products under Development for Waldenstrom Macroglobulinemia, H1 2015 10

Number of Products under Development for Waldenstrom Macroglobulinemia-Comparative Analysis, H1 2015 11

Number of Products under Development by Companies, H1 2015 13

Comparative Analysis by Late Stage Development, H1 2015 14

Comparative Analysis by Clinical Stage Development, H1 2015 15

Comparative Analysis by Early Stage Development, H1 2015 16

Products under Development by Companies, H1 2015 17

Products under Development by Companies, H1 2015 (Contd..1) 18

Waldenstrom Macroglobulinemia-Pipeline by AbbVie Inc., H1 2015 19

Waldenstrom Macroglobulinemia-Pipeline by arGEN-X BV, H1 2015 20

Waldenstrom Macroglobulinemia-Pipeline by Bayer AG, H1 2015 21

Waldenstrom Macroglobulinemia-Pipeline by Calithera Biosciences, Inc., H1 2015 22

Waldenstrom Macroglobulinemia-Pipeline by Celgene Corporation, H1 2015 23

Waldenstrom Macroglobulinemia-Pipeline by Genmab A/S, H1 2015 24

Waldenstrom Macroglobulinemia-Pipeline by Gilead Sciences, Inc., H1 2015 25

Waldenstrom Macroglobulinemia-Pipeline by Idera Pharmaceuticals, Inc., H1 2015 26

Waldenstrom Macroglobulinemia-Pipeline by Immune System Therapeutics Ltd., H1 2015 27

Waldenstrom Macroglobulinemia-Pipeline by Incyte Corporation, H1 2015 28

Waldenstrom Macroglobulinemia-Pipeline by Karyopharm Therapeutics, Inc., H1 2015 29

Waldenstrom Macroglobulinemia-Pipeline by Merck KGaA, H1 2015 30

Waldenstrom Macroglobulinemia-Pipeline by Millennium Pharmaceuticals, Inc., H1 2015 31

Waldenstrom Macroglobulinemia-Pipeline by Nimbus Therapeutics, LLC, H1 2015 32

Waldenstrom Macroglobulinemia-Pipeline by Nordic Nanovector AS, H1 2015 33

Waldenstrom Macroglobulinemia-Pipeline by Novartis AG, H1 2015 34

Waldenstrom Macroglobulinemia-Pipeline by Onyx Pharmaceuticals, Inc., H1 2015 35

Waldenstrom Macroglobulinemia-Pipeline by Pharmacyclics, Inc., H1 2015 36

Assessment by Monotherapy Products, H1 2015 37

Number of Products by Stage and Target, H1 2015 39

Number of Products by Stage and Mechanism of Action, H1 2015 41

Number of Products by Stage and Route of Administration, H1 2015 43

Number of Products by Stage and Molecule Type, H1 2015 45

Waldenstrom Macroglobulinemia Therapeutics-Recent Pipeline Updates, H1 2015 115

Waldenstrom Macroglobulinemia-Dormant Projects, H1 2015 188

Waldenstrom Macroglobulinemia-Discontinued Products, H1 2015 189

List of Figures

Number of Products under Development for Waldenstrom Macroglobulinemia, H1 2015 10

Number of Products under Development for Waldenstrom Macroglobulinemia-Comparative Analysis, H1 2015 11

Number of Products under Development by Companies, H1 2015 12

Comparative Analysis by Late Stage Development, H1 2015 14

Comparative Analysis by Clinical Stage Development, H1 2015 15

Comparative Analysis by Early Stage Products, H1 2015 16

Assessment by Monotherapy Products, H1 2015 37

Number of Products by Top 10 Targets, H1 2015 38

Number of Products by Stage and Top 10 Targets, H1 2015 38

Number of Products by Top 10 Mechanism of Actions, H1 2015 40

Number of Products by Stage and Top 10 Mechanism of Actions, H1 2015 40

Number of Products by Top 10 Routes of Administration, H1 2015 42

Number of Products by Stage and Top 10 Routes of Administration, H1 2015 43

Number of Products by Top 10 Molecule Types, H1 2015 44

Number of Products by Stage and Top 10 Molecule Types, H1 2015 45

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AbbVie Inc.


Bayer AG

Calithera Biosciences, Inc.

Celgene Corporation

Genmab A/S

Gilead Sciences, Inc.

Idera Pharmaceuticals, Inc.

Immune System Therapeutics Ltd.

Incyte Corporation

Karyopharm Therapeutics, Inc.

Merck KGaA

Millennium Pharmaceuticals, Inc.

Nimbus Therapeutics, LLC

Nordic Nanovector AS

Novartis AG

Onyx Pharmaceuticals, Inc.

Pharmacyclics, Inc.

Waldenstrom Macroglobulinemia Therapeutic Products under Development, Key Players in Waldenstrom Macroglobulinemia Therapeutics, Waldenstrom Macroglobulinemia Pipeline Overview, Waldenstrom Macroglobulinemia Pipeline, Waldenstrom Macroglobulinemia Pipeline Assessment

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