Shire Plc – Product Pipeline Review

Global Markets Direct’s, ‘Shire Plc – Product Pipeline Review – 2016’, provides an overview of the Shire Plc’s pharmaceutical research and development focus.

The report provides comprehensive information on the therapeutics under development by Shire Plc, 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 the 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 pipeline therapeutic landscape of Shire Plc

The report provides overview of Shire Plc including its business description, key facts, and locations and subsidiaries

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 covers pipeline products based on various stages of development ranging from pre-registration till discovery and undisclosed stages

The report assesses Shire Plc’s pipeline therapeutics based on drug target, mechanism of action (MoA), route of administration (RoA) and molecule type

The report features Shire Plc’s out-licensed and partnered product portfolio and summarizes its dormant and discontinued projects

Reasons to buy

Evaluate Shire Plc’s strategic position with total access to detailed information on its product pipeline

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 Shire Plc

Identify potential new clients or partners in the target demographic

Plan mergers and acquisitions effectively by identifying key players and it’s most promising pipeline therapeutics

Devise corrective measures for pipeline projects by understanding Shire Plc’s pipeline depth and focus of pipeline 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

Table of Contents

Table of Contents

Table of Contents 2

List of Tables 8

List of Figures 8

Shire Plc Snapshot 9

Shire Plc Overview 9

Key Information 9

Key Facts 9

Shire Plc - Research and Development Overview 10

Key Therapeutic Areas 10

Shire Plc - Pipeline Review 14

Pipeline Products by Stage of Development 14

Pipeline Products - Monotherapy 15

Pipeline Products - Partnered Products 16

Partnered Products/Combination Treatment Modalities 17

Pipeline Products - Out-Licensed Products 18

Out-Licensed Products/Combination Treatment Modalities 19

Shire Plc - Pipeline Products Glance 20

Shire Plc - Late Stage Pipeline Products 20

Pre-Registration Products/Combination Treatment Modalities 20

Phase III Products/Combination Treatment Modalities 21

Shire Plc - Clinical Stage Pipeline Products 22

Phase II Products/Combination Treatment Modalities 22

Phase I Products/Combination Treatment Modalities 23

Shire Plc - Early Stage Pipeline Products 24

Preclinical Products/Combination Treatment Modalities 24

Shire Plc - Unknown Stage Pipeline Products 25

Unknown Products/Combination Treatment Modalities 25

Shire Plc - Drug Profiles 26

guanfacine hydrochloride ER 26

Product Description 26

Mechanism of Action 26

R&D Progress 26

lifitegrast 28

Product Description 28

Mechanism of Action 28

R&D Progress 28

parathyroid hormone 31

Product Description 31

Mechanism of Action 31

R&D Progress 31

agalsidase alfa 34

Product Description 34

Mechanism of Action 34

R&D Progress 34

budesonide 36

Product Description 36

Mechanism of Action 36

R&D Progress 36

C1 esterase inhibitor (human) 37

Product Description 37

Mechanism of Action 37

R&D Progress 37

icatibant acetate 39

Product Description 39

Mechanism of Action 39

R&D Progress 39

lanadelumab 41

Product Description 41

Mechanism of Action 41

R&D Progress 41

lisdexamfetamine dimesylate 42

Product Description 42

Mechanism of Action 42

R&D Progress 42

prucalopride succinate 46

Product Description 46

Mechanism of Action 46

R&D Progress 46

SHP-465 48

Product Description 48

Mechanism of Action 48

R&D Progress 48

teduglutide (recombinant) 49

Product Description 49

Mechanism of Action 49

R&D Progress 49

idursulfase 51

Product Description 51

Mechanism of Action 51

R&D Progress 51

maribavir 53

Product Description 53

Mechanism of Action 53

R&D Progress 53

mecasermin rinfabate (recombinant) 55

Product Description 55

Mechanism of Action 55

R&D Progress 55

revexepride 58

Product Description 58

Mechanism of Action 58

R&D Progress 58

SHP-610 59

Product Description 59

Mechanism of Action 59

R&D Progress 59

SHP-625 60

Product Description 60

Mechanism of Action 60

R&D Progress 60

SHP-635 61

Product Description 61

Mechanism of Action 61

R&D Progress 61

SHP-640 62

Product Description 62

Mechanism of Action 62

R&D Progress 62

VP-20621 64

Product Description 64

Mechanism of Action 64

R&D Progress 64

SHP-611 65

Product Description 65

Mechanism of Action 65

R&D Progress 65

SHP-622 66

Product Description 66

Mechanism of Action 66

R&D Progress 66

SHP-623 68

Product Description 68

Mechanism of Action 68

R&D Progress 68

SHP-627 69

Product Description 69

Mechanism of Action 69

R&D Progress 69

volixibat potassium 70

Product Description 70

Mechanism of Action 70

R&D Progress 70

Drugs for Rare Diseases 71

Product Description 71

Mechanism of Action 71

R&D Progress 71

DX-2507 72

Product Description 72

Mechanism of Action 72

R&D Progress 72

DX-4012 73

Product Description 73

Mechanism of Action 73

R&D Progress 73

Gene Therapy to Activate GTP Cyclohydrolase I for Parkinson's Disease 74

Product Description 74

Mechanism of Action 74

R&D Progress 74

HTL-1071 75

Product Description 75

Mechanism of Action 75

R&D Progress 75

Monoclonal Antibodies for Genetic Diseases 76

Product Description 76

Mechanism of Action 76

R&D Progress 76

SC-435 77

Product Description 77

Mechanism of Action 77

R&D Progress 77

SHP-630 78

Product Description 78

Mechanism of Action 78

R&D Progress 78

SHP-637 79

Product Description 79

Mechanism of Action 79

R&D Progress 79

SHP-639 80

Product Description 80

Mechanism of Action 80

R&D Progress 80

SHP-641 81

Product Description 81

Mechanism of Action 81

R&D Progress 81

etiguanfacine 82

Product Description 82

Mechanism of Action 82

R&D Progress 82

Shire Plc - Pipeline Analysis 83

Shire Plc - Pipeline Products by Target 83

Shire Plc - Pipeline Products by Route of Administration 85

Shire Plc - Pipeline Products by Molecule Type 86

Shire Plc - Pipeline Products by Mechanism of Action 87

Shire Plc - Recent Pipeline Updates 89

Shire Plc - Dormant Projects 126

Shire Plc - Discontinued Pipeline Products 128

Discontinued Pipeline Product Profiles 128

NRP-290 128

SPD-452 129

SPD-453 129

SPD-756 129

ALX-0646 129

BMN-185 129

C1 esterase inhibitor (human) 129

CX-516 129

ecallantide 130

HCV-796 130

HGT-1111 130

HGT-2610 130

icatibant acetate 130

isovaleramide 130

lisdexamfetamine dimesylate 130

mesalamine ER 131

metoclopramide hydrochloride 131

ramatercept 131

SHP-557 131

SHP-613 131

SHP-628 131

SPD-491 131

SPD-554 131

SPD-556 132

valrocemide 132

Shire Plc - Company Statement 133

Shire Plc - Locations And Subsidiaries 136

Head Office 136

Other Locations & Subsidiaries 136

Shire Plc - Key Manufacturing Facilities 143

Appendix 144

Methodology 144

Coverage 144

Secondary Research 144

Primary Research 144

Expert Panel Validation 144

Contact Us 144

Disclaimer 145

List of Tables

List of Tables

Shire Plc, Key Information 9

Shire Plc, Key Facts 9

Shire Plc – Pipeline by Indication, 2016 11

Shire Plc – Pipeline by Stage of Development, 2016 14

Shire Plc – Monotherapy Products in Pipeline, 2016 15

Shire Plc – Partnered Products in Pipeline, 2016 16

Shire Plc – Partnered Products/ Combination Treatment Modalities, 2016 17

Shire Plc – Out-Licensed Products in Pipeline, 2016 18

Shire Plc – Out-Licensed Products/ Combination Treatment Modalities, 2016 19

Shire Plc – Pre-Registration, 2016 20

Shire Plc – Phase III, 2016 21

Shire Plc – Phase II, 2016 22

Shire Plc – Phase I, 2016 23

Shire Plc – Preclinical, 2016 24

Shire Plc – Unknown, 2016 25

Shire Plc – Pipeline by Target, 2016 83

Shire Plc – Pipeline by Route of Administration, 2016 85

Shire Plc – Pipeline by Molecule Type, 2016 86

Shire Plc – Pipeline Products by Mechanism of Action, 2016 87

Shire Plc – Recent Pipeline Updates, 2016 89

Shire Plc – Dormant Developmental Projects,2016 126

Shire Plc – Discontinued Pipeline Products, 2016 128

Shire Plc, Other Locations 136

Shire Plc, Subsidiaries 136

Shire Plc, Key Manufacturing Facilities 143

List of Figures

List of Figures

Shire Plc – Pipeline by Top 10 Indication, 2016 11

Shire Plc – Pipeline by Stage of Development, 2016 14

Shire Plc – Monotherapy Products in Pipeline, 2016 15

Shire Plc – Partnered Products in Pipeline, 2016 16

Shire Plc – Out-Licensed Products in Pipeline, 2016 18

Shire Plc – Pipeline by Top 10 Target, 2016 83

Shire Plc – Pipeline by Route of Administration, 2016 85

Shire Plc – Pipeline by Top 10 Molecule Type, 2016 86

Shire Plc – Pipeline Products by Top 10 Mechanism of Action, 2016 87

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