Aplastic Anemia – Pipeline Review, H2 2016

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

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

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

The report assesses Aplastic Anemia 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 Aplastic Anemia

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 Aplastic Anemia

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 Aplastic Anemia 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

3SBio Inc

Acceleron Pharma Inc

Amgen Inc

BioLineRx Ltd

F. Hoffmann-La Roche Ltd

Gamida Cell Ltd

Pluristem Therapeutics Inc

Regen BioPharma 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

Aplastic Anemia Overview 7

Therapeutics Development 8

Pipeline Products for Aplastic Anemia - Overview 8

Aplastic Anemia - Therapeutics under Development by Companies 9

Aplastic Anemia - Pipeline Products Glance 10

Late Stage Products 10

Clinical Stage Products 11

Early Stage Products 12

Aplastic Anemia - Products under Development by Companies 13

Aplastic Anemia - Companies Involved in Therapeutics Development 14

3SBio Inc 14

Acceleron Pharma Inc 15

Amgen Inc 16

BioLineRx Ltd 17

F. Hoffmann-La Roche Ltd 18

Gamida Cell Ltd 19

Pluristem Therapeutics Inc 20

Regen BioPharma Inc 21

Aplastic Anemia - Therapeutics Assessment 22

Assessment by Monotherapy Products 22

Assessment by Target 23

Assessment by Mechanism of Action 25

Assessment by Route of Administration 27

Assessment by Molecule Type 29

Drug Profiles 31

Anemir - Drug Profile 31

Product Description 31

Mechanism Of Action 31

R&D Progress 31

BL-8040 - Drug Profile 32

Product Description 32

Mechanism Of Action 32

R&D Progress 32

Cell Therapy for Aplastic Anemia - Drug Profile 42

Product Description 42

Mechanism Of Action 42

R&D Progress 42

CordIn - Drug Profile 43

Product Description 43

Mechanism Of Action 43

R&D Progress 43

Gene Therapy to Activate Telomerase for Aplastic Anemia - Drug Profile 44

Product Description 44

Mechanism Of Action 44

R&D Progress 44

HemaXellerate - Drug Profile 45

Product Description 45

Mechanism Of Action 45

R&D Progress 45

PLXR-18 - Drug Profile 48

Product Description 48

Mechanism Of Action 48

R&D Progress 48

romiplostim - Drug Profile 54

Product Description 54

Mechanism Of Action 54

R&D Progress 54

sotatercept - Drug Profile 57

Product Description 57

Mechanism Of Action 57

R&D Progress 57

thrombopoietin - Drug Profile 61

Product Description 61

Mechanism Of Action 61

R&D Progress 61

Aplastic Anemia - Dormant Projects 62

Aplastic Anemia - Discontinued Products 63

Aplastic Anemia - Product Development Milestones 64

Featured News & Press Releases 64

Oct 24, 2016: Pan Am Cancer Treatment Center Provides Final HemaXellerate Clinical Data to Regen BioPharma, for treatment of Bone Marrow Suppression Study 64

Sep 22, 2016: Regen BioPharma Responds to FDA Comments on Its Application for Orphan Drug Designation on its Aplastic Anemia Therapy 64

May 11, 2016: Regen BioPharma Discusses Recent Developments in Aplastic Anemia Therapy and Future Potential Expansion of HemaXellerate 65

May 03, 2016: Regen BioPharma Receives Preliminary Clinical Data from Pan Am Cancer Center Regarding Their HemaXellerate Study in Cancer Patients 66

Jan 26, 2016: Regen BioPharma Submits Application to FDA for Orphan Drug Designation for its HemaXellerate Product 67

Dec 15, 2015: Regen BioPharma Receives FDA Clearance to Initiate Clinical Trial of HemaXellerate 67

Nov 23, 2015: BioLineRx Announces Initiation of Phase 1/2 Trial for Novel Treatment in Two Bone Marrow Failure Conditions 68

Nov 17, 2015: Regen BioPharma Submits Response to FDA Questions on HemaXellerate Investigational New Drug Application 69

Nov 17, 2015: Pluristem to Present New Data on PLX-R18 at American Society of Hematology’s Annual Meeting 69

Sep 25, 2015: Regen BioPharma Announces Positive Results from GLP Safety Study for HemaXellerate 70

Sep 10, 2015: BioLineRx Announces Regulatory Submission for Phase 2 Trial of BL-8040 as Novel Treatment for Hypoplastic Myelodysplastic Syndrome and Aplastic Anemia 71

Jul 21, 2015: Regen BioPharma Successfully Completes in Life Portion of Experiments Requested by FDA for HemaXellerate Pre-Clinical Study 71

Jul 09, 2015: Regen BioPharma Reports Successful Dosing of HemaXellerate in FDA-Requested GLP Animal Study 72

May 05, 2015: Regen BioPharma presents HemaXellerate at the 13th International Symposium on Myelodysplastic Syndromes Held April 29 to May 2, 2015 in Washington, DC 73

Apr 22, 2015: Regen BioPharma Engages Charles River Laboratories to Initiate FDA-Requested Study to Support Initiation of HemaXellerate Clinical Trial 73

Appendix 74

Methodology 74

Coverage 74

Secondary Research 74

Primary Research 74

Expert Panel Validation 74

Contact Us 74

Disclaimer 75

List of Tables

List of Tables

Number of Products under Development for Aplastic Anemia, 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

Aplastic Anemia – Pipeline by 3SBio Inc, H2 2016 14

Aplastic Anemia – Pipeline by Acceleron Pharma Inc, H2 2016 15

Aplastic Anemia – Pipeline by Amgen Inc, H2 2016 16

Aplastic Anemia – Pipeline by BioLineRx Ltd, H2 2016 17

Aplastic Anemia – Pipeline by F. Hoffmann-La Roche Ltd, H2 2016 18

Aplastic Anemia – Pipeline by Gamida Cell Ltd, H2 2016 19

Aplastic Anemia – Pipeline by Pluristem Therapeutics Inc, H2 2016 20

Aplastic Anemia – Pipeline by Regen BioPharma Inc, H2 2016 21

Assessment by Monotherapy Products, H2 2016 22

Number of Products by Stage and Target, H2 2016 24

Number of Products by Stage and Mechanism of Action, H2 2016 26

Number of Products by Stage and Route of Administration, H2 2016 28

Number of Products by Stage and Molecule Type, H2 2016 30

Aplastic Anemia – Dormant Projects, H2 2016 62

Aplastic Anemia – Discontinued Products, H2 2016 63

List of Figures

List of Figures

Number of Products under Development for Aplastic Anemia, H2 2016 8

Number of Products under Development by Companies, H2 2016 9

Comparative Analysis by Clinical Stage Development, H2 2016 11

Comparative Analysis by Early Stage Products, H2 2016 12

Assessment by Monotherapy Products, H2 2016 22

Number of Products by Targets, H2 2016 23

Number of Products by Stage and Targets, H2 2016 23

Number of Products by Mechanism of Actions, H2 2016 25

Number of Products by Stage and Mechanism of Actions, H2 2016 25

Number of Products by Routes of Administration, H2 2016 27

Number of Products by Stage and Routes of Administration, H2 2016 27

Number of Products by Molecule Types, H2 2016 29

Number of Products by Stage and Molecule Types, H2 2016 29

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