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Relapsed Chronic Lymphocytic Leukemia (CLL)-Pipeline Review, H1 2015

Relapsed Chronic Lymphocytic Leukemia (CLL)-Pipeline Review, H1 2015


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Executive Summary

Relapsed Chronic Lymphocytic Leukemia (CLL)-Pipeline Review, H1 2015

Summary

Global Markets Direct's, 'Relapsed Chronic Lymphocytic Leukemia (CLL)-Pipeline Review, H1 2015', provides an overview of the Relapsed Chronic Lymphocytic Leukemia (CLL)'s therapeutic pipeline.

This report provides comprehensive information on the therapeutic development for Relapsed Chronic Lymphocytic Leukemia (CLL), 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 Relapsed Chronic Lymphocytic Leukemia (CLL) 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.

Scope

The report provides a snapshot of the global therapeutic landscape of Relapsed Chronic Lymphocytic Leukemia (CLL)

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 Relapsed Chronic Lymphocytic Leukemia (CLL) and enlists all their major and minor projects

The report summarizes all the dormant and discontinued pipeline projects

A review of the Relapsed Chronic Lymphocytic Leukemia (CLL) 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 Relapsed Chronic Lymphocytic Leukemia (CLL) 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 Relapsed Chronic Lymphocytic Leukemia (CLL)

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

Devise corrective measures for pipeline projects by understanding Relapsed Chronic Lymphocytic Leukemia (CLL) 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

Table of Contents

Table of Contents 2

List of Tables 8

List of Figures 9

Introduction 10

Global Markets Direct Report Coverage 10

Relapsed Chronic Lymphocytic Leukemia (CLL) Overview 11

Therapeutics Development 12

Pipeline Products for Relapsed Chronic Lymphocytic Leukemia (CLL)-Overview 12

Pipeline Products for Relapsed Chronic Lymphocytic Leukemia (CLL)-Comparative Analysis 13

Relapsed Chronic Lymphocytic Leukemia (CLL)-Therapeutics under Development by Companies 14

Relapsed Chronic Lymphocytic Leukemia (CLL)-Therapeutics under Investigation by Universities/Institutes 18

Relapsed Chronic Lymphocytic Leukemia (CLL)-Pipeline Products Glance 19

Late Stage Products 19

Clinical Stage Products 20

Relapsed Chronic Lymphocytic Leukemia (CLL)-Products under Development by Companies 21

Relapsed Chronic Lymphocytic Leukemia (CLL)-Products under Investigation by Universities/Institutes 24

Relapsed Chronic Lymphocytic Leukemia (CLL)-Companies Involved in Therapeutics Development 25

4SC AG 25

AbbVie Inc. 26

Astellas Pharma Inc. 27

Astex Pharmaceuticals, Inc. 28

AstraZeneca Plc 29

Boehringer Ingelheim GmbH 30

Bristol-Myers Squibb Company 31

Celgene Corporation 32

Emergent BioSolutions Inc. 33

F. Hoffmann-La Roche Ltd. 34

Genmab A/S 35

Gilead Sciences, Inc. 36

GlaxoSmithKline Plc 37

ImmunoGen, Inc. 38

Immunomedics, Inc. 39

Infinity Pharmaceuticals, Inc. 40

Innate Pharma SA 41

Juno Therapeutics Inc. 42

Karyopharm Therapeutics, Inc. 43

Les Laboratoires Servier SAS 44

LFB S.A. 45

MedImmune, LLC 46

Millennium Pharmaceuticals, Inc. 47

MorphoSys AG 48

Neopharm Ltd. 49

Novartis AG 50

Ono Pharmaceutical Co., Ltd. 51

Portola Pharmaceuticals, Inc. 52

Sanofi 53

TG Therapeutics, Inc. 54

Threshold Pharmaceuticals, Inc. 55

Relapsed Chronic Lymphocytic Leukemia (CLL)-Therapeutics Assessment 56

Assessment by Monotherapy Products 56

Assessment by Combination Products 57

Assessment by Target 58

Assessment by Mechanism of Action 61

Assessment by Route of Administration 63

Assessment by Molecule Type 65

Drug Profiles 67

4SC-202-Drug Profile 67

Product Description 67

Mechanism of Action 67

R&D Progress 67

ACP-196-Drug Profile 69

Product Description 69

Mechanism of Action 69

R&D Progress 69

afuresertib hydrochloride-Drug Profile 71

Product Description 71

Mechanism of Action 71

R&D Progress 71

AGS-67E-Drug Profile 73

Product Description 73

Mechanism of Action 73

R&D Progress 73

AT-7519-Drug Profile 74

Product Description 74

Mechanism of Action 74

R&D Progress 74

AZD-6738-Drug Profile 77

Product Description 77

Mechanism of Action 77

R&D Progress 77

BI-836826-Drug Profile 78

Product Description 78

Mechanism of Action 78

R&D Progress 78

BMS-986016-Drug Profile 79

Product Description 79

Mechanism of Action 79

R&D Progress 79

buparlisib hydrochloride-Drug Profile 80

Product Description 80

Mechanism of Action 80

R&D Progress 80

CC-122-Drug Profile 84

Product Description 84

Mechanism of Action 84

R&D Progress 84

Cell Therapy to Target Receptor Tyrosine Kinase-Like Orphan Receptor 1 for Chronic Lymphocytic Leukemia-Drug Profile 86

Product Description 86

Mechanism of Action 86

R&D Progress 86

cerdulatinib-Drug Profile 87

Product Description 87

Mechanism of Action 87

R&D Progress 87

duvelisib-Drug Profile 88

Product Description 88

Mechanism of Action 88

R&D Progress 88

evofosfamide-Drug Profile 90

Product Description 90

Mechanism of Action 90

R&D Progress 90

FBTA-05-Drug Profile 98

Product Description 98

Mechanism of Action 98

R&D Progress 98

GS-9901-Drug Profile 99

Product Description 99

Mechanism of Action 99

R&D Progress 99

IMGN-529-Drug Profile 100

Product Description 100

Mechanism of Action 100

R&D Progress 100

IMMU-114-Drug Profile 102

Product Description 102

Mechanism of Action 102

R&D Progress 102

IPH-2201-Drug Profile 103

Product Description 103

Mechanism of Action 103

R&D Progress 103

JCAR-014-Drug Profile 105

Product Description 105

Mechanism of Action 105

R&D Progress 105

JCAR-015-Drug Profile 106

Product Description 106

Mechanism of Action 106

R&D Progress 106

MEDI-551-Drug Profile 108

Product Description 108

Mechanism of Action 108

R&D Progress 108

MOR-208-Drug Profile 110

Product Description 110

Mechanism of Action 110

R&D Progress 110

moxetumomab pasudotox-Drug Profile 112

Product Description 112

Mechanism of Action 112

R&D Progress 112

nivolumab-Drug Profile 114

Product Description 114

Mechanism of Action 114

R&D Progress 114

obinutuzumab-Drug Profile 120

Product Description 120

Mechanism of Action 120

R&D Progress 120

ofatumumab-Drug Profile 123

Product Description 123

Mechanism of Action 123

R&D Progress 123

Oshadi D + Oshadi R-Drug Profile 128

Product Description 128

Mechanism of Action 128

R&D Progress 128

otlertuzumab-Drug Profile 129

Product Description 129

Mechanism of Action 129

R&D Progress 129

pilaralisib-Drug Profile 131

Product Description 131

Mechanism of Action 131

R&D Progress 131

S-055746-Drug Profile 134

Product Description 134

Mechanism of Action 134

R&D Progress 134

selinexor-Drug Profile 135

Product Description 135

Mechanism of Action 135

R&D Progress 135

spebrutinib besylate-Drug Profile 140

Product Description 140

Mechanism of Action 140

R&D Progress 140

TAK-659-Drug Profile 142

Product Description 142

Mechanism of Action 142

R&D Progress 142

TGR-1202-Drug Profile 143

Product Description 143

Mechanism of Action 143

R&D Progress 143

tisagenlecleucel-T-Drug Profile 145

Product Description 145

Mechanism of Action 145

R&D Progress 145

ublituximab-Drug Profile 147

Product Description 147

Mechanism of Action 147

R&D Progress 147

ublituximab [INN] + TGR-1202-Drug Profile 149

Product Description 149

Mechanism of Action 149

R&D Progress 149

UC-961-Drug Profile 150

Product Description 150

Mechanism of Action 150

R&D Progress 150

ulocuplumab-Drug Profile 151

Product Description 151

Mechanism of Action 151

R&D Progress 151

urelumab-Drug Profile 153

Product Description 153

Mechanism of Action 153

R&D Progress 153

venetoclax-Drug Profile 155

Product Description 155

Mechanism of Action 155

R&D Progress 155

Relapsed Chronic Lymphocytic Leukemia (CLL)-Recent Pipeline Updates 158

Relapsed Chronic Lymphocytic Leukemia (CLL)-Dormant Projects 233

Relapsed Chronic Lymphocytic Leukemia (CLL)-Discontinued Products 235

Relapsed Chronic Lymphocytic Leukemia (CLL)-Product Development Milestones 236

Featured News & Press Releases 236

May 31, 2015: TG Therapeutics Announces Presentations of Its Proprietary Combination of TG-1101 Plus TGR-1202 in Ongoing Phase I/Ib Dose Escalation Clinical Studies 236

May 21, 2015: Ofatumumab Data to Be Presented at 20th Congress of EHA 237

May 11, 2015: Abbvie To Present New Data From Studies Of Duvelisib Assets In Multiple Cancers At The 51st American Society Of Clinical Oncology Annual Meeting 239

May 06, 2015: Investigational Medicine Venetoclax Receives Breakthrough Therapy Designation In Relapsed Or Refractory Chronic Lymphocytic Leukemia In Previously Treated Patients With The 17P Deletion Genetic Mutation 240

Dec 05, 2014: Roche to present clinical data on obinutuzumab at ASH 240

Nov 06, 2014: Portola Pharmaceuticals Announces Upcoming Presentations on Cerdulatinib at the American Society of Hematology 2014 Annual Meeting 241

Nov 06, 2014: Infinity Announces Clinical and Preclincal Data for Duvelisib to Be Presented at ASH 2014 Annual Meeting 242

Nov 06, 2014: Genmab Announces Additional Data from Phase III Study of Ofatumumab as Maintenance Therapy for Relapsed CLL 243

Nov 06, 2014: Genmab Announces Ofatumumab Data to Be Presented at American Society of Hematology Annual Meeting (ASH) 244

Jul 31, 2014: GSK and Genmab announce positive interim result for phase III study of ofatumumab as maintenance therapy for relapsed CLL 245

Appendix 246

Methodology 246

Coverage 246

Secondary Research 246

Primary Research 246

Expert Panel Validation 246

Contact Us 246

Disclaimer 247

List of Tables

Number of Products under Development for Relapsed Chronic Lymphocytic Leukemia (CLL), H1 2015 12

Number of Products under Development for Relapsed Chronic Lymphocytic Leukemia (CLL)-Comparative Analysis, H1 2015 13

Number of Products under Development by Companies, H1 2015 15

Number of Products under Development by Companies, H1 2015 (Contd..1) 16

Number of Products under Development by Companies, H1 2015 (Contd..2) 17

Number of Products under Investigation by Universities/Institutes, H1 2015 18

Comparative Analysis by Late Stage Development, H1 2015 19

Comparative Analysis by Clinical Stage Development, H1 2015 20

Products under Development by Companies, H1 2015 21

Products under Development by Companies, H1 2015 (Contd..1) 22

Products under Development by Companies, H1 2015 (Contd..2) 23

Products under Investigation by Universities/Institutes, H1 2015 24

Relapsed Chronic Lymphocytic Leukemia (CLL)-Pipeline by 4SC AG, H1 2015 25

Relapsed Chronic Lymphocytic Leukemia (CLL)-Pipeline by AbbVie Inc., H1 2015 26

Relapsed Chronic Lymphocytic Leukemia (CLL)-Pipeline by Astellas Pharma Inc., H1 2015 27

Relapsed Chronic Lymphocytic Leukemia (CLL)-Pipeline by Astex Pharmaceuticals, Inc., H1 2015 28

Relapsed Chronic Lymphocytic Leukemia (CLL)-Pipeline by AstraZeneca Plc, H1 2015 29

Relapsed Chronic Lymphocytic Leukemia (CLL)-Pipeline by Boehringer Ingelheim GmbH, H1 2015 30

Relapsed Chronic Lymphocytic Leukemia (CLL)-Pipeline by Bristol-Myers Squibb Company, H1 2015 31

Relapsed Chronic Lymphocytic Leukemia (CLL)-Pipeline by Celgene Corporation, H1 2015 32

Relapsed Chronic Lymphocytic Leukemia (CLL)-Pipeline by Emergent BioSolutions Inc., H1 2015 33

Relapsed Chronic Lymphocytic Leukemia (CLL)-Pipeline by F. Hoffmann-La Roche Ltd., H1 2015 34

Relapsed Chronic Lymphocytic Leukemia (CLL)-Pipeline by Genmab A/S, H1 2015 35

Relapsed Chronic Lymphocytic Leukemia (CLL)-Pipeline by Gilead Sciences, Inc., H1 2015 36

Relapsed Chronic Lymphocytic Leukemia (CLL)-Pipeline by GlaxoSmithKline Plc, H1 2015 37

Relapsed Chronic Lymphocytic Leukemia (CLL)-Pipeline by ImmunoGen, Inc., H1 2015 38

Relapsed Chronic Lymphocytic Leukemia (CLL)-Pipeline by Immunomedics, Inc., H1 2015 39

Relapsed Chronic Lymphocytic Leukemia (CLL)-Pipeline by Infinity Pharmaceuticals, Inc., H1 2015 40

Relapsed Chronic Lymphocytic Leukemia (CLL)-Pipeline by Innate Pharma SA, H1 2015 41

Relapsed Chronic Lymphocytic Leukemia (CLL)-Pipeline by Juno Therapeutics Inc., H1 2015 42

Relapsed Chronic Lymphocytic Leukemia (CLL)-Pipeline by Karyopharm Therapeutics, Inc., H1 2015 43

Relapsed Chronic Lymphocytic Leukemia (CLL)-Pipeline by Les Laboratoires Servier SAS, H1 2015 44

Relapsed Chronic Lymphocytic Leukemia (CLL)-Pipeline by LFB S.A., H1 2015 45

Relapsed Chronic Lymphocytic Leukemia (CLL)-Pipeline by MedImmune, LLC, H1 2015 46

Relapsed Chronic Lymphocytic Leukemia (CLL)-Pipeline by Millennium Pharmaceuticals, Inc., H1 2015 47

Relapsed Chronic Lymphocytic Leukemia (CLL)-Pipeline by MorphoSys AG, H1 2015 48

Relapsed Chronic Lymphocytic Leukemia (CLL)-Pipeline by Neopharm Ltd., H1 2015 49

Relapsed Chronic Lymphocytic Leukemia (CLL)-Pipeline by Novartis AG, H1 2015 50

Relapsed Chronic Lymphocytic Leukemia (CLL)-Pipeline by Ono Pharmaceutical Co., Ltd., H1 2015 51

Relapsed Chronic Lymphocytic Leukemia (CLL)-Pipeline by Portola Pharmaceuticals, Inc., H1 2015 52

Relapsed Chronic Lymphocytic Leukemia (CLL)-Pipeline by Sanofi, H1 2015 53

Relapsed Chronic Lymphocytic Leukemia (CLL)-Pipeline by TG Therapeutics, Inc., H1 2015 54

Relapsed Chronic Lymphocytic Leukemia (CLL)-Pipeline by Threshold Pharmaceuticals, Inc., H1 2015 55

Assessment by Monotherapy Products, H1 2015 56

Assessment by Combination Products, H1 2015 57

Number of Products by Stage and Target, H1 2015 59

Number of Products by Stage and Mechanism of Action, H1 2015 62

Number of Products by Stage and Route of Administration, H1 2015 64

Number of Products by Stage and Molecule Type, H1 2015 66

Relapsed Chronic Lymphocytic Leukemia (CLL) Therapeutics-Recent Pipeline Updates, H1 2015 158

Relapsed Chronic Lymphocytic Leukemia (CLL)-Dormant Projects, H1 2015 233

Relapsed Chronic Lymphocytic Leukemia (CLL)-Dormant Projects (Contd..1), H1 2015 234

Relapsed Chronic Lymphocytic Leukemia (CLL)-Discontinued Products, H1 2015 235

List of Figures

Number of Products under Development for Relapsed Chronic Lymphocytic Leukemia (CLL), H1 2015 12

Number of Products under Development for Relapsed Chronic Lymphocytic Leukemia (CLL)-Comparative Analysis, H1 2015 13

Number of Products under Development by Companies, H1 2015 14

Comparative Analysis by Clinical Stage Development, H1 2015 20

Assessment by Monotherapy Products, H1 2015 56

Number of Products by Top 10 Targets, H1 2015 58

Number of Products by Stage and Top 10 Targets, H1 2015 58

Number of Products by Top 10 Mechanism of Actions, H1 2015 61

Number of Products by Stage and Top 10 Mechanism of Actions, H1 2015 61

Number of Products by Top 10 Routes of Administration, H1 2015 63

Number of Products by Stage and Top 10 Routes of Administration, H1 2015 63

Number of Products by Top 10 Molecule Types, H1 2015 65

Number of Products by Stage and Top 10 Molecule Types, H1 2015 65

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4SC AG

AbbVie Inc.

Astellas Pharma Inc.

Astex Pharmaceuticals, Inc.

AstraZeneca Plc

Boehringer Ingelheim GmbH

Bristol-Myers Squibb Company

Celgene Corporation

Emergent BioSolutions Inc.

F. Hoffmann-La Roche Ltd.

Genmab A/S

Gilead Sciences, Inc.

GlaxoSmithKline Plc

ImmunoGen, Inc.

Immunomedics, Inc.

Infinity Pharmaceuticals, Inc.

Innate Pharma SA

Juno Therapeutics Inc.

Karyopharm Therapeutics, Inc.

Les Laboratoires Servier SAS

LFB S.A.

MedImmune, LLC

Millennium Pharmaceuticals, Inc.

MorphoSys AG

Neopharm Ltd.

Novartis AG

Ono Pharmaceutical Co., Ltd.

Portola Pharmaceuticals, Inc.

Sanofi

TG Therapeutics, Inc.

Threshold Pharmaceuticals, Inc.

Relapsed Chronic Lymphocytic Leukemia (CLL) Therapeutic Products under Development, Key Players in Relapsed Chronic Lymphocytic Leukemia (CLL) Therapeutics, Relapsed Chronic Lymphocytic Leukemia (CLL) Pipeline Overview, Relapsed Chronic Lymphocytic Leukemia (CLL) Pipeline, Relapsed Chronic Lymphocytic Leukemia (CLL) Pipeline Assessment


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