Hypoparathyroidism – Pipeline Review, H2 2016

Global Markets Direct’s, ‘Hypoparathyroidism – Pipeline Review, H2 2016’, 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 Company

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

Therapeutics Development 7

Pipeline Products for Hypoparathyroidism - Overview 7

Hypoparathyroidism - Therapeutics under Development by Companies 8

Hypoparathyroidism - Pipeline Products Glance 9

Late Stage Products 9

Clinical Stage Products 10

Early Stage Products 11

Hypoparathyroidism - Products under Development by Companies 12

Hypoparathyroidism - Companies Involved in Therapeutics Development 13

Ascendis Pharma A/S 13

Chugai Pharmaceutical Co Ltd 14

Eli Lilly and Company 15

Shire Plc 16

Hypoparathyroidism - Therapeutics Assessment 17

Assessment by Monotherapy Products 17

Assessment by Target 18

Assessment by Mechanism of Action 20

Assessment by Route of Administration 22

Assessment by Molecule Type 24

Drug Profiles 26

Eu-232 - Drug Profile 26

Product Description 26

Mechanism Of Action 26

R&D Progress 26

parathyroid hormone - Drug Profile 27

Product Description 27

Mechanism Of Action 27

R&D Progress 27

PCO-371 - Drug Profile 31

Product Description 31

Mechanism Of Action 31

R&D Progress 31

PTH-RM - Drug Profile 32

Product Description 32

Mechanism Of Action 32

R&D Progress 32

Recombinant Peptide to Agonize Parathyroid Hormone Receptor for Hypoparathyroidism - Drug Profile 33

Product Description 33

Mechanism Of Action 33

R&D Progress 33

Recombinant Protein to Agonize PTHR1 for Hypoparathyroidism - Drug Profile 34

Product Description 34

Mechanism Of Action 34

R&D Progress 34

teriparatide - Drug Profile 35

Product Description 35

Mechanism Of Action 35

R&D Progress 35

Hypoparathyroidism - Dormant Projects 36

Hypoparathyroidism - Product Development Milestones 37

Featured News & Press Releases 37

Jan 23, 2015: FDA approves Natpara to control low blood calcium levels in patients with hypoparathyroidism 37

Dec 02, 2014: European Medicines Agency Validates Marketing Authorization Application for Natpar (parathyroid hormone (rDNA)) in Hypoparathyroidism 38

Oct 23, 2014: PDUFA Action Date For Natpara BLA Extended Three Months To January 24, 2015 38

Sep 12, 2014: FDA Advisory Committee Recommends Approval of Natpara for Long-Term Treatment of Hypoparathyroidism 39

Sep 12, 2014: FDA Advisory Committee to Review Natpara Biologics License Application 39

Sep 10, 2014: FDA Posts Briefing Materials for Advisory Committee Meeting Reviewing Natpara for Hypoparathyroidism 39

Jul 24, 2014: PARADOX Findings Published in Endocrine Practice Describe High Burden of Illness in Patients with Hypoparathyroidism 40

Jun 10, 2014: NPS Pharma Reports Change in Tentative Date of FDA Advisory Committee Review of Natpara BLA to September 12 - PDUFA Date of October 24 Remains Unchanged 41

Jan 07, 2014: NPS Pharmaceuticals Announces FDA Acceptance of Biologics License Application for Natpara for the Treatment of Hypoparathyroidism 41

Jan 03, 2014: NPS Pharmaceuticals Receives Orphan Drug Designation for Natpara in Europe 42

Oct 24, 2013: NPS Pharmaceuticals Submits Biologic License Application to the U.S. Food and Drug Administration for Natpara in Hypoparathyroidism 42

Oct 07, 2013: Natpara Pivotal Study Published in The Lancet Diabetes & Endocrinology 44

Oct 07, 2013: New Findings from the REPLACE Study Suggest Natpara Has a Beneficial Effect on Bone Health in Patients with Hypoparathyroidism 45

Jun 17, 2013: NPS Pharma To Present Data On Natpara As Parathyroid Hormone Replacement Therapy In Patients With Hypoparathyroidism At ENDO 2013 47

Jun 05, 2013: NPS Pharma Announces Presentation Of Data From Natpara REPLACE Study And PARADOX Study At ENDO 2013 49

Appendix 50

Methodology 50

Coverage 50

Secondary Research 50

Primary Research 50

Expert Panel Validation 50

Contact Us 50

Disclaimer 51

List of Tables

List of Tables

Number of Products under Development for Hypoparathyroidism, H2 2016 7

Number of Products under Development by Companies, H2 2016 8

Comparative Analysis by Late Stage Development, H2 2016 9

Comparative Analysis by Clinical Stage Development, H2 2016 10

Comparative Analysis by Early Stage Development, H2 2016 11

Products under Development by Companies, H2 2016 12

Hypoparathyroidism – Pipeline by Ascendis Pharma A/S, H2 2016 13

Hypoparathyroidism – Pipeline by Chugai Pharmaceutical Co Ltd, H2 2016 14

Hypoparathyroidism – Pipeline by Eli Lilly and Company, H2 2016 15

Hypoparathyroidism – Pipeline by Shire Plc, H2 2016 16

Assessment by Monotherapy Products, H2 2016 17

Number of Products by Stage and Target, H2 2016 19

Number of Products by Stage and Mechanism of Action, H2 2016 21

Number of Products by Stage and Route of Administration, H2 2016 23

Number of Products by Stage and Molecule Type, H2 2016 25

Hypoparathyroidism – Dormant Projects, H2 2016 36

List of Figures

List of Figures

Number of Products under Development for Hypoparathyroidism, H2 2016 7

Number of Products under Development by Companies, H2 2016 8

Comparative Analysis by Clinical Stage Development, H2 2016 10

Assessment by Monotherapy Products, H2 2016 17

Number of Products by Targets, H2 2016 18

Number of Products by Stage and Targets, H2 2016 18

Number of Products by Mechanism of Actions, H2 2016 20

Number of Products by Stage and Mechanism of Actions, H2 2016 20

Number of Products by Routes of Administration, H2 2016 22

Number of Products by Stage and Routes of Administration, H2 2016 22

Number of Products by Molecule Types, H2 2016 24

Number of Products by Stage and Molecule Types, H2 2016 24

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