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Published: Aug, 2014 | Pages:
96 | Publisher: Global Markets Direct
Industry: Healthcare | Report Format: Electronic (PDF)
Hemophilia B - Pipeline Review, H2 2014 Summary Global Markets Direct's, 'Hemophilia B - Pipeline Review, H2 2014', 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 - Pipeline Products Glance 14 Late Stage Products 14 Clinical Stage Products 15 Early Stage Products 16 Hemophilia B - Products under Development by Companies 17 Hemophilia B - Companies Involved in Therapeutics Development 18 Baxter International Inc. 18 AstraZeneca PLC 19 Emergent BioSolutions Inc. 20 Sangamo BioSciences, Inc. 21 Novo Nordisk A/S 22 rEVO Biologics 23 Pfizer Inc. 24 OPKO Health, Inc. 25 ReGenX Biosciences, LLC 26 Alnylam Pharmaceuticals, Inc. 27 CSL Limited 28 Catalyst Biosciences, Inc. 29 Amarna Therapeutics B.V. 30 AlphaMab Co., Ltd 31 Hemophilia B - Therapeutics Assessment 32 Assessment by Monotherapy Products 32 Assessment by Target 33 Assessment by Mechanism of Action 35 Assessment by Route of Administration 37 Assessment by Molecule Type 39 Drug Profiles 41 coagulation factor IX (recombinant) - Drug Profile 41 Product Description 41 Mechanism of Action 41 R&D Progress 41 trenonacog alfa - Drug Profile 43 Product Description 43 Mechanism of Action 43 R&D Progress 43 CSL-654 - Drug Profile 45 Product Description 45 Mechanism of Action 45 R&D Progress 45 nonacog beta pegol - Drug Profile 47 Product Description 47 Mechanism of Action 47 R&D Progress 47 LR-769 - Drug Profile 49 Product Description 49 Mechanism of Action 49 R&D Progress 49 coagulation factor VIIa (recombinant) - Drug Profile 51 Product Description 51 Mechanism of Action 51 R&D Progress 51 CSL-689 - Drug Profile 52 Product Description 52 Mechanism of Action 52 R&D Progress 52 nonacog alfa biosimilar - Drug Profile 54 Product Description 54 Mechanism of Action 54 R&D Progress 54 AMT-060 - Drug Profile 55 Product Description 55 Mechanism of Action 55 R&D Progress 55 AskBio-009 - Drug Profile 56 Product Description 56 Mechanism of Action 56 R&D Progress 56 Gene Therapy to Activate Factor IX for Hemophilia B - Drug Profile 57 Product Description 57 Mechanism of Action 57 R&D Progress 57 PF-05280602 - Drug Profile 58 Product Description 58 Mechanism of Action 58 R&D Progress 58 concizumab - Drug Profile 59 Product Description 59 Mechanism of Action 59 R&D Progress 59 Gene Therapy to Activate Factor IX for Hemophilia B - Drug Profile 60 Product Description 60 Mechanism of Action 60 R&D Progress 60 ALN-AT3 - Drug Profile 61 Product Description 61 Mechanism of Action 61 R&D Progress 61 eptacog alfa - Drug Profile 62 Product Description 62 Mechanism of Action 62 R&D Progress 62 ZFP Transcription Factors for Hemophilia - Drug Profile 63 Product Description 63 Mechanism of Action 63 R&D Progress 63 MOD-5014 - Drug Profile 64 Product Description 64 Mechanism of Action 64 R&D Progress 64 CB-2679d - Drug Profile 66 Product Description 66 Mechanism of Action 66 R&D Progress 66 Gene Therapy for Hemophilia B - Drug Profile 67 Product Description 67 Mechanism of Action 67 R&D Progress 67 SVF-VIIa - Drug Profile 68 Product Description 68 Mechanism of Action 68 R&D Progress 68 AZ-10047130 - Drug Profile 69 Product Description 69 Mechanism of Action 69 R&D Progress 69 AZ-10776241 - Drug Profile 70 Product Description 70 Mechanism of Action 70 R&D Progress 70 Hemophilia B - Recent Pipeline Updates 71 Hemophilia B - Dormant Projects 85 Hemophilia B - Discontinued Products 86 Hemophilia B - Product Development Milestones 87 Featured News & Press Releases 87 Jul 16, 2014: Pfizer Announces Positive Top-Line Results From Phase 3 Study Of NONACOG ALFA (BeneFIX) Once-Weekly Prophylaxis For Hemophilia B 87 Jul 09, 2014: OPKO's Long-Acting Clotting Factor VIIa-CTP Receives Positive Opinion For Three Orphan Drug Designations in Europe 88 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 88 May 11, 2014: New Findings Support Less Frequent Dosing in Hemophilia B Patients Treated with Coagulation Factor IX with Recombinant Albumin 89 Mar 03, 2014: LFB Initiates Global Phase 3 Clinical Trial of New Coagulation Factor VIIa (Recombinant) in Patients with Hemophilia A and B 90 Feb 28, 2014: OPKO's Longer-Acting Clotting Factor VIIa-CTP Receives Orphan Drug Designation in the U.S. 90 Dec 09, 2013: Baxter Files for Pediatric Indication of RIXUBIS [Coagulation Factor IX (Recombinant)] Treatment for Hemophilia B in the United States 91 Oct 31, 2013: Baxter Submits Application for European Approval of RIXUBIS, Recombinant Factor IX (nonacog gamma) for Hemophilia B 91 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 92 Aug 20, 2013: Alnylam Receives Additional Orphan Drug Designation from U.S. Food & Drug Administration for ALN-AT3, an RNAi Therapeutic for the Treatment of Hemophilia 93 Appendix 95 Methodology 95 Coverage 95 Secondary Research 95 Primary Research 95 Expert Panel Validation 95 Contact Us 96 Disclaimer 96
List of Tables Number of Products under Development for Hemophilia B, H2 2014 10 Number of Products under Development for Hemophilia B - Comparative Analysis, H2 2014 11 Number of Products under Development by Companies, H2 2014 13 Comparative Analysis by Late Stage Development, H2 2014 14 Comparative Analysis by Clinical Stage Development, H2 2014 15 Comparative Analysis by Early Stage Development, H2 2014 16 Products under Development by Companies, H2 2014 17 Hemophilia B - Pipeline by Baxter International Inc., H2 2014 18 Hemophilia B - Pipeline by AstraZeneca PLC, H2 2014 19 Hemophilia B - Pipeline by Emergent BioSolutions Inc., H2 2014 20 Hemophilia B - Pipeline by Sangamo BioSciences, Inc., H2 2014 21 Hemophilia B - Pipeline by Novo Nordisk A/S, H2 2014 22 Hemophilia B - Pipeline by rEVO Biologics, H2 2014 23 Hemophilia B - Pipeline by Pfizer Inc., H2 2014 24 Hemophilia B - Pipeline by OPKO Health, Inc., H2 2014 25 Hemophilia B - Pipeline by ReGenX Biosciences, LLC, H2 2014 26 Hemophilia B - Pipeline by Alnylam Pharmaceuticals, Inc., H2 2014 27 Hemophilia B - Pipeline by CSL Limited, H2 2014 28 Hemophilia B - Pipeline by Catalyst Biosciences, Inc., H2 2014 29 Hemophilia B - Pipeline by Amarna Therapeutics B.V., H2 2014 30 Hemophilia B - Pipeline by AlphaMab Co., Ltd, H2 2014 31 Assessment by Monotherapy Products, H2 2014 32 Number of Products by Stage and Target, H2 2014 34 Number of Products by Stage and Mechanism of Action, H2 2014 36 Number of Products by Stage and Route of Administration, H2 2014 38 Number of Products by Stage and Molecule Type, H2 2014 40 Hemophilia B Therapeutics - Recent Pipeline Updates, H2 2014 71 Hemophilia B - Dormant Projects, H2 2014 85 Hemophilia B - Discontinued Products, H2 2014 86
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