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Hemophilia B-Pipeline Review, H1 2015

Hemophilia B-Pipeline Review, H1 2015


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Executive Summary

Hemophilia B-Pipeline Review, H1 2015

Summary

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

This report provides comprehensive information on the therapeutic development for Hemophilia B, 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 Hemophilia B 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 Hemophilia B

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 Hemophilia B and enlists all their major and minor projects

The report summarizes all the dormant and discontinued pipeline projects

A review of the Hemophilia B 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 Hemophilia B 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 Hemophilia B

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

Devise corrective measures for pipeline projects by understanding Hemophilia B 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 6

List of Figures 7

Introduction 8

Global Markets Direct Report Coverage 8

Hemophilia B Overview 9

Therapeutics Development 10

Pipeline Products for Hemophilia B-Overview 10

Pipeline Products for Hemophilia B-Comparative Analysis 11

Hemophilia B-Therapeutics under Development by Companies 12

Hemophilia B-Therapeutics under Investigation by Universities/Institutes 14

Hemophilia B-Pipeline Products Glance 15

Late Stage Products 15

Clinical Stage Products 16

Early Stage Products 17

Hemophilia B-Products under Development by Companies 18

Hemophilia B-Products under Investigation by Universities/Institutes 20

Hemophilia B-Companies Involved in Therapeutics Development 21

Alnylam Pharmaceuticals, Inc. 21

Amarna Therapeutics B.V. 22

AstraZeneca PLC 23

Bayer AG 24

Biogen, Inc. 25

Catalyst Biosciences, Inc. 26

CSL Limited 27

Dimension Therapeutics, Inc. 28

Emergent BioSolutions Inc. 29

Novo Nordisk A/S 30

OPKO Health, Inc. 31

Pharming Group N.V. 32

rEVO Biologics 33

Sangamo BioSciences, Inc. 34

Spark Therapeutics, Inc. 35

The International Biotechnology Center (IBC) Generium 36

uniQure N.V. 37

Hemophilia B-Therapeutics Assessment 38

Assessment by Monotherapy Products 38

Assessment by Target 39

Assessment by Mechanism of Action 41

Assessment by Route of Administration 43

Assessment by Molecule Type 45

Drug Profiles 47

albutrepenonacog alfa-Drug Profile 47

Product Description 47

Mechanism of Action 47

R&D Progress 47

ALN-AT3-Drug Profile 49

Product Description 49

Mechanism of Action 49

R&D Progress 49

AMT-060-Drug Profile 50

Product Description 50

Mechanism of Action 50

R&D Progress 50

AZ-10047130-Drug Profile 51

Product Description 51

Mechanism of Action 51

R&D Progress 51

BAX-335-Drug Profile 52

Product Description 52

Mechanism of Action 52

R&D Progress 52

BAY-1093884-Drug Profile 53

Product Description 53

Mechanism of Action 53

R&D Progress 53

CB-2679d-Drug Profile 54

Product Description 54

Mechanism of Action 54

R&D Progress 54

Cell Therapy for Hemophilia B-Drug Profile 55

Product Description 55

Mechanism of Action 55

R&D Progress 55

coagulation factor IX (recombinant)-Drug Profile 56

Product Description 56

Mechanism of Action 56

R&D Progress 56

coagulation factor VIIa (recombinant)-Drug Profile 58

Product Description 58

Mechanism of Action 58

R&D Progress 58

concizumab-Drug Profile 60

Product Description 60

Mechanism of Action 60

R&D Progress 60

CSL-689-Drug Profile 61

Product Description 61

Mechanism of Action 61

R&D Progress 61

DTX-101-Drug Profile 63

Product Description 63

Mechanism of Action 63

R&D Progress 63

Gene Therapy for Hemophilia B-Drug Profile 64

Product Description 64

Mechanism of Action 64

R&D Progress 64

Gene Therapy to Activate Factor IX for Hemophilia B-Drug Profile 65

Product Description 65

Mechanism of Action 65

R&D Progress 65

LR-769-Drug Profile 66

Product Description 66

Mechanism of Action 66

R&D Progress 66

MOD-5014-Drug Profile 68

Product Description 68

Mechanism of Action 68

R&D Progress 68

nonacog alfa biosimilar-Drug Profile 70

Product Description 70

Mechanism of Action 70

R&D Progress 70

nonacog beta pegol-Drug Profile 71

Product Description 71

Mechanism of Action 71

R&D Progress 71

PF-05280602-Drug Profile 73

Product Description 73

Mechanism of Action 73

R&D Progress 73

Recombinant Enzyme to Replace Factor IX for Hemophilia B-Drug Profile 74

Product Description 74

Mechanism of Action 74

R&D Progress 74

SHP-624-Drug Profile 75

Product Description 75

Mechanism of Action 75

R&D Progress 75

SPK-FIX-Drug Profile 76

Product Description 76

Mechanism of Action 76

R&D Progress 76

SVF-VIIa-Drug Profile 77

Product Description 77

Mechanism of Action 77

R&D Progress 77

Hemophilia B-Recent Pipeline Updates 78

Hemophilia B-Dormant Projects 96

Hemophilia B-Discontinued Products 97

Hemophilia B-Product Development Milestones 98

Featured News & Press Releases 98

Mar 30, 2015: European Medicines Agency Commences Review of CSL Behring's Regulatory Submission for rIX-FP for Hemophilia B Patients 98

Mar 24, 2015: LFB Receives Go Ahead From Data Monitoring Committee to Expand The Global PERSEPT Phase 3 Program of LR769 in Hemophilia A or B Patients with Inhibitors 98

Mar 13, 2015: Baxter BioScience Announces Positive Phase III Results for BAX 817, Investigational Recombinant Treatment for Hemophilia A and B Patients with Inhibitors 99

Feb 04, 2015: U.S. FDA Accepts for Review CSL Behring's Biologics License Application for rIX-FP for Hemophilia B Patients 100

Dec 17, 2014: LFB Announces Achievement of Patient Enrollment Target for PerSept 1 Program for the Evaluation of Recombinant Factor Seven Efficacy by Prospective Clinical Trials 100

Dec 16, 2014: CSL Behring Submits Biologics License Application for FDA Approval of Recombinant Fusion Protein Linking Coagulation Factor IX with Recombinant Albumin (rIX-FP) for Hemophilia B Patients 100

May 14, 2014: LFB SA Announces That First Patient Has Begun Treatment with New Coagulation Factor VIIa (Recombinant) in Global Phase 3 Clinical Trial in Hemophilia A and B with Inhibitors 101

May 11, 2014: New Findings Support Less Frequent Dosing in Hemophilia B Patients Treated with Coagulation Factor IX with Recombinant Albumin 101

Mar 03, 2014: LFB Initiates Global Phase 3 Clinical Trial of New Coagulation Factor VIIa (Recombinant) in Patients with Hemophilia A and B 102

Oct 29, 2013: Alnylam Files Clinical Trial Application to Initiate a Phase I Study for ALN-AT3, a Subcutaneously Administered RNAi Therapeutic Targeting Antithrombin for the Treatment of Hemophilia A and B 103

Appendix 105

Methodology 105

Coverage 105

Secondary Research 105

Primary Research 105

Expert Panel Validation 105

Contact Us 105

Disclaimer 106

List of Tables

Number of Products under Development for Hemophilia B, H1 2015 10

Number of Products under Development for Hemophilia B-Comparative Analysis, H1 2015 11

Number of Products under Development by Companies, H1 2015 13

Number of Products under Investigation by Universities/Institutes, H1 2015 14

Comparative Analysis by Late Stage Development, H1 2015 15

Comparative Analysis by Clinical Stage Development, H1 2015 16

Comparative Analysis by Early Stage Development, H1 2015 17

Products under Development by Companies, H1 2015 18

Products under Development by Companies, H1 2015 (Contd..1) 19

Products under Investigation by Universities/Institutes, H1 2015 20

Hemophilia B-Pipeline by Alnylam Pharmaceuticals, Inc., H1 2015 21

Hemophilia B-Pipeline by Amarna Therapeutics B.V., H1 2015 22

Hemophilia B-Pipeline by AstraZeneca PLC, H1 2015 23

Hemophilia B-Pipeline by Bayer AG, H1 2015 24

Hemophilia B-Pipeline by Biogen, Inc., H1 2015 25

Hemophilia B-Pipeline by Catalyst Biosciences, Inc., H1 2015 26

Hemophilia B-Pipeline by CSL Limited, H1 2015 27

Hemophilia B-Pipeline by Dimension Therapeutics, Inc., H1 2015 28

Hemophilia B-Pipeline by Emergent BioSolutions Inc., H1 2015 29

Hemophilia B-Pipeline by Novo Nordisk A/S, H1 2015 30

Hemophilia B-Pipeline by OPKO Health, Inc., H1 2015 31

Hemophilia B-Pipeline by Pharming Group N.V., H1 2015 32

Hemophilia B-Pipeline by rEVO Biologics, H1 2015 33

Hemophilia B-Pipeline by Sangamo BioSciences, Inc., H1 2015 34

Hemophilia B-Pipeline by Spark Therapeutics, Inc., H1 2015 35

Hemophilia B-Pipeline by The International Biotechnology Center (IBC) Generium, H1 2015 36

Hemophilia B-Pipeline by uniQure N.V., H1 2015 37

Assessment by Monotherapy Products, H1 2015 38

Number of Products by Stage and Target, H1 2015 40

Number of Products by Stage and Mechanism of Action, H1 2015 42

Number of Products by Stage and Route of Administration, H1 2015 44

Number of Products by Stage and Molecule Type, H1 2015 46

Hemophilia B Therapeutics-Recent Pipeline Updates, H1 2015 78

Hemophilia B-Dormant Projects, H1 2015 96

Hemophilia B-Discontinued Products, H1 2015 97

List of Figures

Number of Products under Development for Hemophilia B, H1 2015 10

Number of Products under Development for Hemophilia B-Comparative Analysis, H1 2015 11

Number of Products under Development by Companies, H1 2015 12

Comparative Analysis by Late Stage Development, H1 2015 15

Comparative Analysis by Clinical Stage Development, H1 2015 16

Comparative Analysis by Early Stage Products, H1 2015 17

Assessment by Monotherapy Products, H1 2015 38

Number of Products by Top 10 Targets, H1 2015 39

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

Number of Products by Top 10 Mechanism of Actions, H1 2015 41

Number of Products by Stage and Top 10 Mechanism of Actions, H1 2015 42

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

Number of Products by Stage and Top 10 Routes of Administration, H1 2015 44

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

Number of Products by Stage and Top 10 Molecule Types, H1 2015 46

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Alnylam Pharmaceuticals, Inc.

Amarna Therapeutics B.V.

AstraZeneca PLC

Bayer AG

Biogen, Inc.

Catalyst Biosciences, Inc.

CSL Limited

Dimension Therapeutics, Inc.

Emergent BioSolutions Inc.

Novo Nordisk A/S

OPKO Health, Inc.

Pharming Group N.V.

rEVO Biologics

Sangamo BioSciences, Inc.

Spark Therapeutics, Inc.

The International Biotechnology Center (IBC) Generium

uniQure N.V.

Hemophilia B Therapeutic Products under Development, Key Players in Hemophilia B Therapeutics, Hemophilia B Pipeline Overview, Hemophilia B Pipeline, Hemophilia B Pipeline Assessment


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