Neutropenia – Pipeline Review, H2 2016

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

The report provides comprehensive information on the therapeutics under development for Neutropenia, 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 Neutropenia 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 Neutropenia

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

The report assesses Neutropenia 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 Neutropenia

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 Neutropenia

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 Neutropenia 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

Apotex Inc.

BeyondSpring Pharmaceuticals, Inc.

Biogenomics Limited

Cellerant Therapeutics, Inc.

Cleveland BioLabs, Inc.

Coherus BioSciences, Inc.

Dr. Reddy's Laboratories Limited

Eurofarma Laboratorios S.A.

Ligand Pharmaceuticals, Inc.

NAL Pharmaceuticals Ltd.

Prolong Pharmaceuticals, LLC

Richter Gedeon Nyrt.

Sandoz International GmbH

Therapeutic Proteins International, LLC

Toko Pharmaceutical Industries Co., Ltd.

USV Pvt Ltd

Table of Contents

Table of Contents

Table of Contents 2

List of Tables 6

List of Figures 7

Introduction 8

Global Markets Direct Report Coverage 8

Neutropenia Overview 9

Therapeutics Development 10

Pipeline Products for Neutropenia - Overview 10

Neutropenia - Therapeutics under Development by Companies 11

Neutropenia - Pipeline Products Glance 14

Late Stage Products 14

Clinical Stage Products 15

Early Stage Products 16

Unknown Stage Products 17

Neutropenia - Products under Development by Companies 18

Neutropenia - Companies Involved in Therapeutics Development 19

Apotex Inc. 19

BeyondSpring Pharmaceuticals, Inc. 20

Biogenomics Limited 21

Cellerant Therapeutics, Inc. 22

Cleveland BioLabs, Inc. 23

Coherus BioSciences, Inc. 24

Dr. Reddy's Laboratories Limited 25

Eurofarma Laboratorios S.A. 26

Ligand Pharmaceuticals, Inc. 27

NAL Pharmaceuticals Ltd. 28

Prolong Pharmaceuticals, LLC 29

Richter Gedeon Nyrt. 30

Sandoz International GmbH 31

Therapeutic Proteins International, LLC 32

Toko Pharmaceutical Industries Co., Ltd. 33

USV Pvt Ltd 34

Neutropenia - Therapeutics Assessment 35

Assessment by Monotherapy Products 35

Assessment by Target 36

Assessment by Mechanism of Action 39

Assessment by Route of Administration 42

Assessment by Molecule Type 44

Drug Profiles 46

ACN-8337 - Drug Profile 46

Product Description 46

Mechanism Of Action 46

R&D Progress 46

CBLB-612 - Drug Profile 47

Product Description 47

Mechanism Of Action 47

R&D Progress 47

EC-18 - Drug Profile 49

Product Description 49

Mechanism Of Action 49

R&D Progress 49

filgrastim - Drug Profile 50

Product Description 50

Mechanism Of Action 50

R&D Progress 50

filgrastim - Drug Profile 51

Product Description 51

Mechanism Of Action 51

R&D Progress 51

filgrastim - Drug Profile 52

Product Description 52

Mechanism Of Action 52

R&D Progress 52

filgrastim - Drug Profile 53

Product Description 53

Mechanism Of Action 53

R&D Progress 53

filgrastim - Drug Profile 54

Product Description 54

Mechanism Of Action 54

R&D Progress 54

LG-7455 - Drug Profile 55

Product Description 55

Mechanism Of Action 55

R&D Progress 55

pegfilgrastim - Drug Profile 56

Product Description 56

Mechanism Of Action 56

R&D Progress 56

pegfilgrastim - Drug Profile 57

Product Description 57

Mechanism Of Action 57

R&D Progress 57

pegfilgrastim - Drug Profile 58

Product Description 58

Mechanism Of Action 58

R&D Progress 58

pegfilgrastim - Drug Profile 59

Product Description 59

Mechanism Of Action 59

R&D Progress 59

pegfilgrastim - Drug Profile 60

Product Description 60

Mechanism Of Action 60

R&D Progress 60

pegfilgrastim - Drug Profile 61

Product Description 61

Mechanism Of Action 61

R&D Progress 61

pegfilgrastim - Drug Profile 62

Product Description 62

Mechanism Of Action 62

R&D Progress 62

pegfilgrastim - Drug Profile 64

Product Description 64

Mechanism Of Action 64

R&D Progress 64

pegfilgrastim - Drug Profile 65

Product Description 65

Mechanism Of Action 65

R&D Progress 65

pegfilgrastim - Drug Profile 66

Product Description 66

Mechanism Of Action 66

R&D Progress 66

pegfilgrastim - Drug Profile 67

Product Description 67

Mechanism Of Action 67

R&D Progress 67

pegfilgrastim - Drug Profile 68

Product Description 68

Mechanism Of Action 68

R&D Progress 68

pegfilgrastim (recombinant) - Drug Profile 69

Product Description 69

Mechanism Of Action 69

R&D Progress 69

plinabulin - Drug Profile 70

Product Description 70

Mechanism Of Action 70

R&D Progress 70

romyelocel-L - Drug Profile 74

Product Description 74

Mechanism Of Action 74

R&D Progress 74

ST-7 - Drug Profile 77

Product Description 77

Mechanism Of Action 77

R&D Progress 77

tamibarotene - Drug Profile 78

Product Description 78

Mechanism Of Action 78

R&D Progress 78

Neutropenia - Dormant Projects 81

Neutropenia - Product Development Milestones 83

Featured News & Press Releases 83

Sep 09, 2016: Apobiologix Announces Victory Over Amgen in Biosimilar (filgrastim) Patent Case 83

Sep 09, 2016: Apobiologix Announces Victory Over Amgen in Biosimilar (pegfilgrastim) Patent Case 83

Jul 11, 2016: Coherus Announces Positive Topline Results For CHS-1701 (Pegfilgrastim Biosimilar Candidate) Pharmacokinetic And Pharmacodynamic Biosimilarity Study 84

May 26, 2016: American Society of Clinical Oncology Selects BeyondSpring Abstract on Neutropenia Mitigation with Plinabulin Use for Publication 85

Mar 31, 2016: Launch of Key Biosimilar Medicine To Help Save Healthcare Budgets 85

Feb 11, 2016: Sandoz advances its biosimilars program with EMA acceptance of regulatory submission for biosimilar pegfilgrastim 86

Feb 01, 2016: Coherus Announces CHS-1701 (Neulasta Biosimilar) Met Both Primary Endpoints in Registration-Enabling Immunogenicity Study 87

Dec 21, 2015: Coherus BioSciences Signs Strategic Manufacturing Agreement With KBI Biopharma for Commercial Supply of CHS-1701 87

Dec 08, 2015: Coherus BioSciences Reports Update to CHS-1701 Program 87

Dec 08, 2015: EMA started the evaluation of Richter’s marketing authorisation application for biosimilar pegfilgrastim 88

Dec 07, 2015: Phase III Data Shows Sandoz’ Proposed Biosimilar Pegfilgrastim has Similar Safety and Efficacy as the Reference Product 88

Nov 18, 2015: Regulatory submission for Sandoz' proposed biosimilar pegfilgrastim accepted by the FDA 89

Oct 01, 2015: Coherus Announces Topline Results of CHS-1701 Pharmacokinetic and Pharmacodynamic Biosimilarity Study 90

Mar 17, 2015: Coherus Finalizes CHS-1701 BLA Enabling Clinical Program and Initiates Pivotal Pharmacokinetic and Pharmacodynamic Study 91

Feb 17, 2015: Apotex Announces FDA Has Accepted For Filing its Biosimilar Application for Filgrastim (Grastofil) 91

Appendix 92

Methodology 92

Coverage 92

Secondary Research 92

Primary Research 92

Expert Panel Validation 92

Contact Us 92

Disclaimer 93

List of Tables

List of Tables

Number of Products under Development for Neutropenia, H2 2016 10

Number of Products under Development by Companies, H2 2016 12

Number of Products under Development by Companies, H2 2016 (Contd..1) 13

Comparative Analysis by Late Stage Development, H2 2016 14

Comparative Analysis by Clinical Stage Development, H2 2016 15

Comparative Analysis by Early Stage Development, H2 2016 16

Comparative Analysis by Unknown Stage Development, H2 2016 17

Products under Development by Companies, H2 2016 18

Neutropenia – Pipeline by Apotex Inc., H2 2016 19

Neutropenia – Pipeline by BeyondSpring Pharmaceuticals, Inc., H2 2016 20

Neutropenia – Pipeline by Biogenomics Limited, H2 2016 21

Neutropenia – Pipeline by Cellerant Therapeutics, Inc., H2 2016 22

Neutropenia – Pipeline by Cleveland BioLabs, Inc., H2 2016 23

Neutropenia – Pipeline by Coherus BioSciences, Inc., H2 2016 24

Neutropenia – Pipeline by Dr. Reddy's Laboratories Limited, H2 2016 25

Neutropenia – Pipeline by Eurofarma Laboratorios S.A., H2 2016 26

Neutropenia – Pipeline by Ligand Pharmaceuticals, Inc., H2 2016 27

Neutropenia – Pipeline by NAL Pharmaceuticals Ltd., H2 2016 28

Neutropenia – Pipeline by Prolong Pharmaceuticals, LLC, H2 2016 29

Neutropenia – Pipeline by Richter Gedeon Nyrt., H2 2016 30

Neutropenia – Pipeline by Sandoz International GmbH, H2 2016 31

Neutropenia – Pipeline by Therapeutic Proteins International, LLC, H2 2016 32

Neutropenia – Pipeline by Toko Pharmaceutical Industries Co., Ltd., H2 2016 33

Neutropenia – Pipeline by USV Pvt Ltd, H2 2016 34

Assessment by Monotherapy Products, H2 2016 35

Number of Products by Stage and Target, H2 2016 37

Number of Products by Stage and Mechanism of Action, H2 2016 40

Number of Products by Stage and Route of Administration, H2 2016 43

Number of Products by Stage and Molecule Type, H2 2016 45

Neutropenia – Dormant Projects, H2 2016 81

Neutropenia – Dormant Projects (Contd..1), H2 2016 82

List of Figures

List of Figures

Number of Products under Development for Neutropenia, H2 2016 10

Number of Products under Development by Companies, H2 2016 11

Comparative Analysis by Late Stage Development, H2 2016 14

Comparative Analysis by Clinical Stage Development, H2 2016 15

Comparative Analysis by Early Stage Products, H2 2016 16

Assessment by Monotherapy Products, H2 2016 35

Number of Products by Top 10 Targets, H2 2016 36

Number of Products by Stage and Top 10 Targets, H2 2016 36

Number of Products by Top 10 Mechanism of Actions, H2 2016 39

Number of Products by Stage and Top 10 Mechanism of Actions, H2 2016 39

Number of Products by Routes of Administration, H2 2016 42

Number of Products by Stage and Routes of Administration, H2 2016 42

Number of Products by Molecule Types, H2 2016 44

Number of Products by Stage and Molecule Types, H2 2016 44

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