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Peripheral T-Cell Lymphomas (PTCL)-Pipeline Review, H1 2015

Peripheral T-Cell Lymphomas (PTCL)-Pipeline Review, H1 2015


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Executive Summary

Peripheral T-Cell Lymphomas (PTCL)-Pipeline Review, H1 2015

Summary

Global Markets Direct's, 'Peripheral T-Cell Lymphomas (PTCL)-Pipeline Review, H1 2015', provides an overview of the Peripheral T-Cell Lymphomas (PTCL)'s therapeutic pipeline.

This report provides comprehensive information on the therapeutic development for Peripheral T-Cell Lymphomas (PTCL), 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 Peripheral T-Cell Lymphomas (PTCL) 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 Peripheral T-Cell Lymphomas (PTCL)

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 Peripheral T-Cell Lymphomas (PTCL) and enlists all their major and minor projects

The report summarizes all the dormant and discontinued pipeline projects

A review of the Peripheral T-Cell Lymphomas (PTCL) 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 Peripheral T-Cell Lymphomas (PTCL) 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 Peripheral T-Cell Lymphomas (PTCL)

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

Devise corrective measures for pipeline projects by understanding Peripheral T-Cell Lymphomas (PTCL) 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 5

List of Figures 6

Introduction 7

Global Markets Direct Report Coverage 7

Peripheral T-Cell Lymphomas (PTCL) Overview 8

Therapeutics Development 9

Pipeline Products for Peripheral T-Cell Lymphomas (PTCL)-Overview 9

Pipeline Products for Peripheral T-Cell Lymphomas (PTCL)-Comparative Analysis 10

Peripheral T-Cell Lymphomas (PTCL)-Therapeutics under Development by Companies 11

Peripheral T-Cell Lymphomas (PTCL)-Pipeline Products Glance 13

Late Stage Products 13

Clinical Stage Products 14

Early Stage Products 15

Peripheral T-Cell Lymphomas (PTCL)-Products under Development by Companies 16

Peripheral T-Cell Lymphomas (PTCL)-Companies Involved in Therapeutics Development 18

AB Science 18

Affimed Therapeutics AG 19

Bayer AG 20

Celgene Corporation 21

Eisai Co., Ltd. 22

Incyte Corporation 23

Karyopharm Therapeutics, Inc. 24

Kyowa Hakko Kirin Co., Ltd. 25

Millennium Pharmaceuticals, Inc. 26

Mundipharma International Limited 27

Onxeo SA 28

Sanofi 29

Solasia Pharma K.K. 30

Spectrum Pharmaceuticals, Inc. 31

TG Therapeutics, Inc. 32

Peripheral T-Cell Lymphomas (PTCL)-Therapeutics Assessment 33

Assessment by Monotherapy Products 33

Assessment by Target 34

Assessment by Mechanism of Action 36

Assessment by Route of Administration 39

Assessment by Molecule Type 41

Drug Profiles 43

AFM-13-Drug Profile 43

Product Description 43

Mechanism of Action 43

R&D Progress 43

alemtuzumab-Drug Profile 44

Product Description 44

Mechanism of Action 44

R&D Progress 44

alisertib-Drug Profile 47

Product Description 47

Mechanism of Action 47

R&D Progress 47

belinostat-Drug Profile 51

Product Description 51

Mechanism of Action 51

R&D Progress 51

copanlisib-Drug Profile 54

Product Description 54

Mechanism of Action 54

R&D Progress 54

darinaparsin-Drug Profile 57

Product Description 57

Mechanism of Action 57

R&D Progress 57

denileukin diftitox-Drug Profile 59

Product Description 59

Mechanism of Action 59

R&D Progress 59

forodesine hydrochloride-Drug Profile 61

Product Description 61

Mechanism of Action 61

R&D Progress 61

lenalidomide-Drug Profile 63

Product Description 63

Mechanism of Action 63

R&D Progress 63

masitinib-Drug Profile 67

Product Description 67

Mechanism of Action 67

R&D Progress 67

mogamulizumab-Drug Profile 70

Product Description 70

Mechanism of Action 70

R&D Progress 70

pralatrexate-Drug Profile 72

Product Description 72

Mechanism of Action 72

R&D Progress 72

romidepsin-Drug Profile 75

Product Description 75

Mechanism of Action 75

R&D Progress 75

ruxolitinib phosphate-Drug Profile 77

Product Description 77

Mechanism of Action 77

R&D Progress 77

selinexor-Drug Profile 82

Product Description 82

Mechanism of Action 82

R&D Progress 82

SH-7129-Drug Profile 86

Product Description 86

Mechanism of Action 86

R&D Progress 86

TGR-1202-Drug Profile 88

Product Description 88

Mechanism of Action 88

R&D Progress 88

Peripheral T-Cell Lymphomas (PTCL)-Recent Pipeline Updates 90

Peripheral T-Cell Lymphomas (PTCL)-Dormant Projects 142

Peripheral T-Cell Lymphomas (PTCL)-Discontinued Products 143

Peripheral T-Cell Lymphomas (PTCL)-Product Development Milestones 144

Featured News & Press Releases 144

Dec 09, 2014: Combination of ISTODAX (romidepsin) and Standard CHOP Demonstrates a Complete Response in 51% of Patients with Peripheral T-Cell Lymphoma 144

Dec 05, 2014: Spectrum Pharmaceuticals Highlights Abstracts on Beleodaq (belinostat) at the 56th Annual Meeting of the ASH in San Francisco 144

Nov 13, 2014: Onxeo Confirms Receipt of the $25M Milestone Payment on Beleodaq 145

Nov 06, 2014: Celgene To Present Phase II Trial Data On Romidepsin at American Society of Hematology Annual Meeting 146

Sep 16, 2014: Spectrum Pharmaceuticals Announces Issue of a New Patent for Beleodaq (belinostat) for Injection with Patent Term Adjustment till 2027 146

Aug 28, 2014: Onxeo Strengthens Beleodaq Patent Protection in the U.S. Until 2027 147

Jul 07, 2014: FDA Grants Spectrum Pharmaceuticals Accelerated Approval of Beleodaq (belinostat) for Injection 147

Jul 03, 2014: BioAlliance Pharma Receives FDA approval for Beleodaq 149

Mar 17, 2014: Approval for Additional Indication for PTCL and CTCL of Mogamulizumab 149

Feb 06, 2014: FDA Grants Acceptance To File And Priority Review For TopoTarget A/S's Beleodaq NDA In PTCL 149

Appendix 152

Methodology 152

Coverage 152

Secondary Research 152

Primary Research 152

Expert Panel Validation 152

Contact Us 152

Disclaimer 153

List of Tables

Number of Products under Development for Peripheral T-Cell Lymphomas (PTCL), H1 2015 9

Number of Products under Development for Peripheral T-Cell Lymphomas (PTCL)-Comparative Analysis, H1 2015 10

Number of Products under Development by Companies, H1 2015 12

Comparative Analysis by Late Stage Development, H1 2015 13

Comparative Analysis by Clinical Stage Development, H1 2015 14

Comparative Analysis by Early Stage Development, H1 2015 15

Products under Development by Companies, H1 2015 16

Products under Development by Companies, H1 2015 (Contd..1) 17

Peripheral T-Cell Lymphomas (PTCL)-Pipeline by AB Science, H1 2015 18

Peripheral T-Cell Lymphomas (PTCL)-Pipeline by Affimed Therapeutics AG, H1 2015 19

Peripheral T-Cell Lymphomas (PTCL)-Pipeline by Bayer AG, H1 2015 20

Peripheral T-Cell Lymphomas (PTCL)-Pipeline by Celgene Corporation, H1 2015 21

Peripheral T-Cell Lymphomas (PTCL)-Pipeline by Eisai Co., Ltd., H1 2015 22

Peripheral T-Cell Lymphomas (PTCL)-Pipeline by Incyte Corporation, H1 2015 23

Peripheral T-Cell Lymphomas (PTCL)-Pipeline by Karyopharm Therapeutics, Inc., H1 2015 24

Peripheral T-Cell Lymphomas (PTCL)-Pipeline by Kyowa Hakko Kirin Co., Ltd., H1 2015 25

Peripheral T-Cell Lymphomas (PTCL)-Pipeline by Millennium Pharmaceuticals, Inc., H1 2015 26

Peripheral T-Cell Lymphomas (PTCL)-Pipeline by Mundipharma International Limited, H1 2015 27

Peripheral T-Cell Lymphomas (PTCL)-Pipeline by Onxeo SA, H1 2015 28

Peripheral T-Cell Lymphomas (PTCL)-Pipeline by Sanofi, H1 2015 29

Peripheral T-Cell Lymphomas (PTCL)-Pipeline by Solasia Pharma K.K., H1 2015 30

Peripheral T-Cell Lymphomas (PTCL)-Pipeline by Spectrum Pharmaceuticals, Inc., H1 2015 31

Peripheral T-Cell Lymphomas (PTCL)-Pipeline by TG Therapeutics, Inc., H1 2015 32

Assessment by Monotherapy Products, H1 2015 33

Number of Products by Stage and Target, H1 2015 35

Number of Products by Stage and Mechanism of Action, H1 2015 38

Number of Products by Stage and Route of Administration, H1 2015 40

Number of Products by Stage and Molecule Type, H1 2015 42

Peripheral T-Cell Lymphomas (PTCL) Therapeutics-Recent Pipeline Updates, H1 2015 90

Peripheral T-Cell Lymphomas (PTCL)-Dormant Projects, H1 2015 142

Peripheral T-Cell Lymphomas (PTCL)-Discontinued Products, H1 2015 143

List of Figures

Number of Products under Development for Peripheral T-Cell Lymphomas (PTCL), H1 2015 9

Number of Products under Development for Peripheral T-Cell Lymphomas (PTCL)-Comparative Analysis, H1 2015 10

Number of Products under Development by Companies, H1 2015 11

Comparative Analysis by Clinical Stage Development, H1 2015 14

Comparative Analysis by Early Stage Products, H1 2015 15

Assessment by Monotherapy Products, H1 2015 33

Number of Products by Top 10 Targets, H1 2015 34

Number of Products by Stage and Top 10 Targets, H1 2015 34

Number of Products by Top 10 Mechanism of Actions, H1 2015 36

Number of Products by Stage and Top 10 Mechanism of Actions, H1 2015 37

Number of Products by Top 10 Routes of Administration, H1 2015 39

Number of Products by Stage and Top 10 Routes of Administration, H1 2015 40

Number of Products by Top 10 Molecule Types, H1 2015 41

Number of Products by Stage and Top 10 Molecule Types, H1 2015 42

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AB Science

Affimed Therapeutics AG

Bayer AG

Celgene Corporation

Eisai Co., Ltd.

Incyte Corporation

Karyopharm Therapeutics, Inc.

Kyowa Hakko Kirin Co., Ltd.

Millennium Pharmaceuticals, Inc.

Mundipharma International Limited

Onxeo SA

Sanofi

Solasia Pharma K.K.

Spectrum Pharmaceuticals, Inc.

TG Therapeutics, Inc.

Peripheral T-Cell Lymphomas (PTCL) Therapeutic Products under Development, Key Players in Peripheral T-Cell Lymphomas (PTCL) Therapeutics, Peripheral T-Cell Lymphomas (PTCL) Pipeline Overview, Peripheral T-Cell Lymphomas (PTCL) Pipeline, Peripheral T-Cell Lymphomas (PTCL) Pipeline Assessment


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