Hypoparathyroidism – Pipeline Review, H2 2017

Global Markets Direct’s, ‘Hypoparathyroidism – Pipeline Review, H2 2017’, provides an overview of the Hypoparathyroidism pipeline landscape.

The report provides comprehensive information on the therapeutics under development for Hypoparathyroidism, 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 latest news and press releases. Additionally, the report provides an overview of key players involved in therapeutic development for Hypoparathyroidism and features 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 global therapeutic landscape of Hypoparathyroidism

The report reviews pipeline therapeutics for Hypoparathyroidism by companies and universities/research institutes based on information derived from company and industry-specific sources

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

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 reviews key players involved Hypoparathyroidism therapeutics and enlists all their major and minor projects

The report assesses Hypoparathyroidism therapeutics based on drug target, mechanism of action (MoA), route of administration (RoA) and molecule type

The report summarizes all the dormant and discontinued pipeline projects

The report reviews latest news related to pipeline therapeutics for Hypoparathyroidism

Reasons to buy

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 Hypoparathyroidism

Identify potential new clients or partners in the target demographic

Develop strategic initiatives by understanding the focus areas of leading companies

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

Devise corrective measures for pipeline projects by understanding Hypoparathyroidism 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

Companies mentioned

Ascendis Pharma A/S

Chugai Pharmaceutical Co Ltd

Eli Lilly and Co

Entera Bio Ltd

Pharis Biotec GmbH

Shire Plc

Table of Contents

Table of Contents

Table of Contents 2

List of Tables 4

List of Figures 4

Introduction 5

Global Markets Direct Report Coverage 5

Hypoparathyroidism - Overview 6

Hypoparathyroidism - Therapeutics Development 7

Pipeline Overview 7

Pipeline by Companies 8

Products under Development by Companies 9

Hypoparathyroidism - Therapeutics Assessment 10

Assessment by Target 10

Assessment by Mechanism of Action 12

Assessment by Route of Administration 14

Assessment by Molecule Type 16

Hypoparathyroidism - Companies Involved in Therapeutics Development 18

Ascendis Pharma A/S 18

Chugai Pharmaceutical Co Ltd 18

Eli Lilly and Co 19

Entera Bio Ltd 19

Pharis Biotec GmbH 19

Shire Plc 20

Hypoparathyroidism - Drug Profiles 21

ACP-014 - Drug Profile 21

Product Description 21

Mechanism Of Action 21

R&D Progress 21

hPTH-137 - Drug Profile 23

Product Description 23

Mechanism Of Action 23

R&D Progress 23

parathyroid hormone - Drug Profile 24

Product Description 24

Mechanism Of Action 24

R&D Progress 24

PCO-371 - Drug Profile 29

Product Description 29

Mechanism Of Action 29

R&D Progress 29

PTH-RM - Drug Profile 30

Product Description 30

Mechanism Of Action 30

R&D Progress 30

Recombinant Protein to Agonize PTHR1 for Hypoparathyroidism - Drug Profile 31

Product Description 31

Mechanism Of Action 31

R&D Progress 31

Synthetic Peptide to Agonize PTH1R and PTH2R for Hypoparathyroidism - Drug Profile 32

Product Description 32

Mechanism Of Action 32

R&D Progress 32

teriparatide - Drug Profile 33

Product Description 33

Mechanism Of Action 33

R&D Progress 33

Hypoparathyroidism - Dormant Projects 34

Hypoparathyroidism - Product Development Milestones 35

Featured News & Press Releases 35

Sep 26, 2017: Ascendis Pharma Announces Dosing of Subjects in Phase 1 Trial of TransCon PTH 35

Sep 05, 2017: Ascendis Pharma Announces Presentations on TransCon PTH at Upcoming Medical Conferences 35

May 19, 2017: Shire to highlight new research into chronic hypoparathyroidism at the European Congress of Endocrinology 36

Apr 26, 2017: Shire Granted EU Conditional Marketing Authorisation for Natpar (Parathyroid Hormone) for the Treatment of Patients with Chronic Hypoparathyroidism 37

Apr 03, 2017: Ascendis Pharma Presents Data on TransCon PTH at ENDO 2017 37

Feb 28, 2017: Ascendis Pharma Announces Data on TransCon PTH at ENDO 2017 38

Feb 24, 2017: First hormone replacement therapy for parathyroid disorder 39

Jun 29, 2016: EnteraBio Receives Orphan Drug Approval for PTH 1-34 from European Medicines Agency 40

Jul 22, 2015: Entera Bio Announces Phase II Results of PTH 1-34 in Treating Hypoparathyroidism 40

Jan 23, 2015: FDA approves Natpara to control low blood calcium levels in patients with hypoparathyroidism 40

Dec 02, 2014: European Medicines Agency Validates Marketing Authorization Application for Natpar (parathyroid hormone (rDNA)) in Hypoparathyroidism 41

Oct 23, 2014: PDUFA Action Date For Natpara BLA Extended Three Months To January 24, 2015 41

Sep 12, 2014: FDA Advisory Committee Recommends Approval of Natpara for Long-Term Treatment of Hypoparathyroidism 42

Sep 12, 2014: FDA Advisory Committee to Review Natpara Biologics License Application 42

Sep 10, 2014: FDA Posts Briefing Materials for Advisory Committee Meeting Reviewing Natpara for Hypoparathyroidism 42

Appendix 43

Methodology 43

Coverage 43

Secondary Research 43

Primary Research 43

Expert Panel Validation 43

Contact Us 43

Disclaimer 44

List of Tables

List of Tables

Number of Products under Development for Hypoparathyroidism, H2 2017 7

Number of Products under Development by Companies, H2 2017 8

Products under Development by Companies, H2 2017 9

Number of Products by Stage and Target, H2 2017 11

Number of Products by Stage and Mechanism of Action, H2 2017 13

Number of Products by Stage and Route of Administration, H2 2017 15

Number of Products by Stage and Molecule Type, H2 2017 17

Hypoparathyroidism – Pipeline by Ascendis Pharma A/S, H2 2017 18

Hypoparathyroidism – Pipeline by Chugai Pharmaceutical Co Ltd, H2 2017 18

Hypoparathyroidism – Pipeline by Eli Lilly and Co, H2 2017 19

Hypoparathyroidism – Pipeline by Entera Bio Ltd, H2 2017 19

Hypoparathyroidism – Pipeline by Pharis Biotec GmbH, H2 2017 20

Hypoparathyroidism – Pipeline by Shire Plc, H2 2017 20

Hypoparathyroidism – Dormant Projects, H2 2017 34

List of Figures

List of Figures

Number of Products under Development for Hypoparathyroidism, H2 2017 7

Number of Products under Development by Companies, H2 2017 8

Number of Products by Targets, H2 2017 10

Number of Products by Stage and Targets, H2 2017 10

Number of Products by Mechanism of Actions, H2 2017 12

Number of Products by Stage and Mechanism of Actions, H2 2017 12

Number of Products by Routes of Administration, H2 2017 14

Number of Products by Stage and Routes of Administration, H2 2017 14

Number of Products by Molecule Types, H2 2017 16

Number of Products by Stage and Molecule Types, H2 2017 16

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