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Hereditary Angioedema (HAE) (C1 Esterase Inhibitor [C1-INH] Deficiency) - Pipeline Review, H2 2015 Is Released

Press Release   •   Feb 03, 2016 19:03 IST

This report provides comprehensive information on the therapeutic development for Hereditary Angioedema (HAE) (C1 Esterase Inhibitor [C1-INH] Deficiency), 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 Hereditary Angioedema (HAE) (C1 Esterase Inhibitor [C1-INH] Deficiency) and special features on late-stage and discontinued projects. Global Markets Directs 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 Directs 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 Directs 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 Hereditary Angioedema (HAE) (C1 Esterase Inhibitor [C1-INH] Deficiency) - 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 Hereditary Angioedema (HAE) (C1 Esterase Inhibitor [C1-INH] Deficiency) and enlists all their major and minor projects - The report summarizes all the dormant and discontinued pipeline projects - A review of the Hereditary Angioedema (HAE) (C1 Esterase Inhibitor [C1-INH] Deficiency) 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 Hereditary Angioedema (HAE) (C1 Esterase Inhibitor [C1-INH] Deficiency) 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 Hereditary Angioedema (HAE) (C1 Esterase Inhibitor [C1-INH] Deficiency) - Plan mergers and acquisitions effectively by identifying key players of the most promising pipeline - Devise corrective measures for pipeline projects by understanding Hereditary Angioedema (HAE) (C1 Esterase Inhibitor [C1-INH] Deficiency) 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

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Table of Contents

Table of Contents 2

List of Tables 5

List of Figures 6

Introduction 7

Global Markets Direct Report Coverage 7

Hereditary Angioedema (HAE) (C1 Esterase Inhibitor [C1-INH] Deficiency) Overview 8

Therapeutics Development 9

Pipeline Products for Hereditary Angioedema (HAE) (C1 Esterase Inhibitor [C1-INH] Deficiency) - Overview 9

Hereditary Angioedema (HAE) (C1 Esterase Inhibitor [C1-INH] Deficiency) - Therapeutics under Development by Companies 10

Hereditary Angioedema (HAE) (C1 Esterase Inhibitor [C1-INH] Deficiency) - Pipeline Products Glance 11

Late Stage Products 11

Clinical Stage Products 12

Early Stage Products 13

Hereditary Angioedema (HAE) (C1 Esterase Inhibitor [C1-INH] Deficiency) - Products under Development by Companies 14

Hereditary Angioedema (HAE) (C1 Esterase Inhibitor [C1-INH] Deficiency) - Companies Involved in Therapeutics Development 16

Arrowhead Research Corporation 16

BioCryst Pharmaceuticals, Inc. 17

Cevec Pharmaceuticals GmbH 18

CSL Limited 19

Dyax Corp. 20

Global Blood Therapeutics, Inc. 21

iBio, Inc. 22

Isis Pharmaceuticals, Inc. 23

Pharming Group N.V. 24

ProMetic Life Sciences Inc. 25

Ra Pharmaceuticals, Inc. 26

Shire Plc 27

Hereditary Angioedema (HAE) (C1 Esterase Inhibitor [C1-INH] Deficiency) - Therapeutics Assessment 28

Assessment by Monotherapy Products 28

Assessment by Target 29

Assessment by Mechanism of Action 31

Assessment by Route of Administration 33

Assessment by Molecule Type 35

Drug Profiles 37

ARCF-12 - Drug Profile 37

Product Description 37

Mechanism of Action 37

R&D Progress 37

avoralstat - Drug Profile 38

Product Description 38

Mechanism of Action 38

R&D Progress 38

BCX-7353 - Drug Profile 39

Product Description 39

Mechanism of Action 39

R&D Progress 39

BEL-0215 - Drug Profile 40

Product Description 40

Mechanism of Action 40

R&D Progress 40

C1 esterase inhibitor (human) - Drug Profile 41

Product Description 41

Mechanism of Action 41

R&D Progress 41

C1 esterase inhibitor (human) - Drug Profile 44

Product Description 44

Mechanism of Action 44

R&D Progress 44

C1 esterase inhibitor (human) - Drug Profile 46

Product Description 46

Mechanism of Action 46

R&D Progress 46

C1 esterase inhibitor (human) - Drug Profile 51

Product Description 51

Mechanism of Action 51

R&D Progress 51

C1 esterase inhibitor (recombinant) - Drug Profile 52

Product Description 52

Mechanism of Action 52

R&D Progress 52

CSL-312 - Drug Profile 53

Product Description 53

Mechanism of Action 53

R&D Progress 53

icatibant acetate - Drug Profile 54

Product Description 54

Mechanism of Action 54

R&D Progress 54

ISIS-PKKRx - Drug Profile 56

Product Description 56

Mechanism of Action 56

R&D Progress 56

lanadelumab - Drug Profile 57

Product Description 57

Mechanism of Action 57

R&D Progress 57

Recombinant Protein to Inhibit C1-esterase for Hereditary Angioedema - Drug Profile 58

Product Description 58

Mechanism of Action 58

R&D Progress 58

SHP-623 - Drug Profile 59

Product Description 59

Mechanism of Action 59

R&D Progress 59

Small Molecule 2 to Inhibit Plasma Kallikrein for Hereditary Angioedema - Drug Profile 60

Product Description 60

Mechanism of Action 60

R&D Progress 60

Small Molecule to Inhibit Kallikrein for Hereditary Angioedema - Drug Profile 61

Product Description 61

Mechanism of Action 61

R&D Progress 61

Small Molecules to Inhibit Plasma Kallikrein for DME and HAE - Drug Profile 62

Product Description 62

Mechanism of Action 62

R&D Progress 62

Synthetic Peptide to Inhibit Kallikrein for Hereditary Angioedema - Drug Profile 64

Product Description 64

Mechanism of Action 64

R&D Progress 64

Hereditary Angioedema (HAE) (C1 Esterase Inhibitor [C1-INH] Deficiency) - Recent Pipeline Updates 65

Hereditary Angioedema (HAE) (C1 Esterase Inhibitor [C1-INH] Deficiency) - Product Development Milestones 80

Featured News & Press Releases 80

Dec 07, 2015: European Medicines Agency Reaffirms Important Health Benefits and Safety of RUCONEST for Patients with Hereditary Angio-edema 80

Nov 09, 2015: Dyax Presents Phase 1b DX-2930 Data at the American College of Allergy, Asthma, and Immunology Annual Meeting 80

Oct 08, 2015: BioCryst Announces Completion of Patient Enrollment in OPuS-2: a Clinical Trial of Avoralstat in Patients with HAE 82

Oct 08, 2015: BioCryst Announces Successful Phase 1 Clinical Trial of BCX7353 82

Oct 08, 2015: FDA Grants RUCONEST (C1 Esterase Inhibitor [Recombinant]) Twelve-Year Reference Product Exclusivity 83

Sep 30, 2015: Dyax Receives Positive Opinion for Orphan Medicinal Product Designation in the European Union for DX-2930 for the Treatment of Hereditary Angioedema 84

Aug 25, 2015: Shire to Attain Enhanced CINRYZE Manufacturing Flexibility and Capacity 84

Aug 12, 2015: Dyax Provides Update on DX-2930 Clinical and Commercial Supply Initiatives 85

Jul 20, 2015: HAEi Global Access Program for RUCONEST Now Live 85

Jul 07, 2015: Dyax Receives FDA Breakthrough Therapy Designation for DX-2930 for Prevention of Attacks of Hereditary Angioedema 86

Appendix 87

Methodology 87

Coverage 87

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