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Shire Plc-Product Pipeline Review-2015

Shire Plc-Product Pipeline Review-2015

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Executive Summary

Shire Plc-Product Pipeline Review-2015


Global Markets Direct's, 'Shire Plc-Product Pipeline Review-2015', provides an overview of the Shire Plc's pharmaceutical research and development focus.

This report provides comprehensive information on the current therapeutic developmental pipeline of Shire Plc's, complete with comparative analysis at various stages, therapeutics assessment by drug target, mechanism of action (MoA), route of administration (RoA) and molecule type. It also reviews latest updates, and featured news and press releases, along with 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.


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

The report reviews current pipeline of Shire Plc's human therapeutic division and enlists all their major and minor projects

The report features product description and descriptive mechanism of action for key pipeline products along with the product's developmental history and major milestones

Special feature on out-licensed and partnered product portfolio

The report summarizes all the dormant and discontinued pipeline projects

Latest company statement

Latest news and deals relating to the Shire Plc's pipeline products

Reasons To Buy

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

Assess the growth potential of Shire Plc in its therapy areas of focus

Identify new drug targets and therapeutic classes in the Shire Plc's R&D portfolio and develop key strategic initiatives to reinforce pipeline in those areas

Exploit in-licensing opportunities by identifying windows of opportunity to fill portfolio gaps

Develop strategic initiatives by understanding the focus areas of Shire Plc and exploit collaboration and partnership opportunities

Identify emerging players with potentially strong product portfolio and create effective counter-strategies to gain competitive advantage

Plan mergers and acquisitions effectively by identifying the most promising pipeline of Shire Plc

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

Explore the dormant and discontinued projects of Shire Plc and identify potential opportunities in those areas

Avoid Intellectual Property Rights related issues

Table of Contents

Table of Contents 2

List of Tables 7

List of Figures 7

Shire Plc Snapshot 8

Shire Plc Overview 8

Key Information 8

Key Facts 8

Shire Plc-Research and Development Overview 9

Key Therapeutic Areas 9

Shire Plc-Pipeline Review 13

Pipeline Products by Stage of Development 13

Pipeline Products-Monotherapy 14

Pipeline Products-Partnered Products 15

Partnered Products/Combination Treatment Modalities 16

Pipeline Products-Out-Licensed Products 17

Out-Licensed Products/Combination Treatment Modalities 18

Shire Plc-Pipeline Products Glance 19

Shire Plc-Late Stage Pipeline Products 19

Pre-Registration Products/Combination Treatment Modalities 19

Filing rejected/Withdrawn 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

Discovery Products/Combination Treatment Modalities 25

Shire Plc-Unknown Stage Pipeline Products 26

Unknown Products/Combination Treatment Modalities 26

Shire Plc-Drug Profiles 27

guanfacine hydrochloride ER 27

Product Description 27

Mechanism of Action 27

R&D Progress 27

lifitegrast 29

Product Description 29

Mechanism of Action 29

R&D Progress 29

parathyroid hormone (recombinant) 31

Product Description 31

Mechanism of Action 31

R&D Progress 31

icatibant acetate 34

Product Description 34

Mechanism of Action 34

R&D Progress 34

C1 esterase inhibitor (human) 36

Product Description 36

Mechanism of Action 36

R&D Progress 36

lisdexamfetamine dimesylate 38

Product Description 38

Mechanism of Action 38

R&D Progress 38

prucalopride succinate 42

Product Description 42

Mechanism of Action 42

R&D Progress 42

SHP-465 44

Product Description 44

Mechanism of Action 44

R&D Progress 44

teduglutide (recombinant) 45

Product Description 45

Mechanism of Action 45

R&D Progress 45

idursulfase 47

Product Description 47

Mechanism of Action 47

R&D Progress 47

budesonide 49

Product Description 49

Mechanism of Action 49

R&D Progress 49

maribavir 50

Product Description 50

Mechanism of Action 50

R&D Progress 50

mecasermin rinfabate (recombinant) 52

Product Description 52

Mechanism of Action 52

R&D Progress 52

SHP-610 54

Product Description 54

Mechanism of Action 54

R&D Progress 54

SHP-625 55

Product Description 55

Mechanism of Action 55

R&D Progress 55

SHP-635 56

Product Description 56

Mechanism of Action 56

R&D Progress 56

SSP-002358 57

Product Description 57

Mechanism of Action 57

R&D Progress 57

VP-20621 58

Product Description 58

Mechanism of Action 58

R&D Progress 58

PVS-10200 59

Product Description 59

Mechanism of Action 59

R&D Progress 59

SHP-611 61

Product Description 61

Mechanism of Action 61

R&D Progress 61

SHP-622 62

Product Description 62

Mechanism of Action 62

R&D Progress 62

NPSP-790 63

Product Description 63

Mechanism of Action 63

R&D Progress 63

SHP-626 64

Product Description 64

Mechanism of Action 64

R&D Progress 64

SHP-627 65

Product Description 65

Mechanism of Action 65

R&D Progress 65

HGT-3010 66

Product Description 66

Mechanism of Action 66

R&D Progress 66

HTL-1071 67

Product Description 67

Mechanism of Action 67

R&D Progress 67

Monoclonal Antibodies for Genetic Diseases 68

Product Description 68

Mechanism of Action 68

R&D Progress 68

Oligonucleotide to Activate CFTR for Cystic Fibrosis 69

Product Description 69

Mechanism of Action 69

R&D Progress 69

SC-435 70

Product Description 70

Mechanism of Action 70

R&D Progress 70

SHP-608 71

Product Description 71

Mechanism of Action 71

R&D Progress 71

SHP-619 72

Product Description 72

Mechanism of Action 72

R&D Progress 72

SHP-628 73

Product Description 73

Mechanism of Action 73

R&D Progress 73

SHP-630 74

Product Description 74

Mechanism of Action 74

R&D Progress 74

SHP-631 75

Product Description 75

Mechanism of Action 75

R&D Progress 75

Antisense Oligonucleotides for Rare Genetic Disorders 76

Product Description 76

Mechanism of Action 76

R&D Progress 76

etiguanfacine 77

Product Description 77

Mechanism of Action 77

R&D Progress 77

Shire Plc-Pipeline Analysis 78

Shire Plc-Pipeline Products by Target 78

Shire Plc-Pipeline Products by Route of Administration 80

Shire Plc-Pipeline Products by Molecule Type 81

Shire Plc-Pipeline Products by Mechanism of Action 82

Shire Plc-Recent Pipeline Updates 84

Shire Plc-Dormant Projects 111

Shire Plc-Dormant Projects 111

Shire Plc-Discontinued Pipeline Products 113

Discontinued Pipeline Product Profiles 113

NRP-290 113

SPD-452 113

SPD-453 114

SPD-756 114

ALX-0646 114

BMN-185 114

CX-516 114

HCV-796 114

HGT-1111 114

HGT-2610 115

isovaleramide 115

lisdexamfetamine dimesylate 115

mesalamine ER 115

metoclopramide hydrochloride 115

ramatercept 115

SHP-557 115

SHP-613 115

SPD-491 116

SPD-554 116

SPD-556 116

valrocemide 116

Shire Plc-Company Statement 117

Shire Plc-Locations And Subsidiaries 119

Head Office 119

Other Locations & Subsidiaries 119

Shire Plc-Key Manufacturing Facilities 125

Appendix 126

Methodology 126

Coverage 126

Secondary Research 126

Primary Research 126

Expert Panel Validation 126

Contact Us 126

Disclaimer 127

List of Tables

Shire Plc, Key Information 8

Shire Plc, Key Facts 8

Shire Plc-Pipeline by Indication, 2015 10

Shire Plc-Pipeline by Stage of Development, 2015 13

Shire Plc-Monotherapy Products in Pipeline, 2015 14

Shire Plc-Partnered Products in Pipeline, 2015 15

Shire Plc-Partnered Products/ Combination Treatment Modalities, 2015 16

Shire Plc-Out-Licensed Products in Pipeline, 2015 17

Shire Plc-Out-Licensed Products/ Combination Treatment Modalities, 2015 18

Shire Plc-Pre-Registration, 2015 19

Shire Plc-Filing rejected/Withdrawn, 2015 20

Shire Plc-Phase III, 2015 21

Shire Plc-Phase II, 2015 22

Shire Plc-Phase I, 2015 23

Shire Plc-Preclinical, 2015 24

Shire Plc-Discovery, 2015 25

Shire Plc-Unknown, 2015 26

Shire Plc-Pipeline by Target, 2015 78

Shire Plc-Pipeline by Route of Administration, 2015 80

Shire Plc-Pipeline by Molecule Type, 2015 81

Shire Plc-Pipeline Products by Mechanism of Action, 2015 82

Shire Plc-Recent Pipeline Updates, 2015 84

Shire Plc-Dormant Developmental Projects,2015 111

Shire Plc-Discontinued Pipeline Products, 2015 113

Shire Plc, Other Locations 119

Shire Plc, Subsidiaries 119

Shire Plc, Key Manufacturing Facilities 125

List of Figures

Shire Plc-Pipeline by Top 10 Indication, 2015 10

Shire Plc-Pipeline by Stage of Development, 2015 13

Shire Plc-Monotherapy Products in Pipeline, 2015 14

Shire Plc-Partnered Products in Pipeline, 2015 15

Shire Plc-Out-Licensed Products in Pipeline, 2015 17

Shire Plc-Pipeline by Top 10 Target, 2015 78

Shire Plc-Pipeline by Top 10 Route of Administration, 2015 80

Shire Plc-Pipeline by Top 10 Molecule Type, 2015 81

Shire Plc-Pipeline Products by Top 10 Mechanism of Action, 2015 82

Single User License:
Report can be used by individual purchaser only

Site License:
Report can be shared by unlimited users within one corporate location, e.g. a regional office

Corporate User License:
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Current R&D Portfolio of Shire Plc; Shire Plc - Key Therapeutics; Shire Plc - Pipeline Overview and Promising Molecules; Shire Plc - News; Shire Plc - Latest Updates; Shire Plc - Pipeline; Shire Plc - Discontinued/Dormant Projects

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