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Hypoparathyroidism - Pipeline Review, H1 2016

  • May 2016
  • -
  • Global Markets Direct
  • -
  • 43 pages

Hypoparathyroidism - Pipeline Review, H1 2016

Summary

Global Markets Direct’s, ‘Hypoparathyroidism - Pipeline Review, H1 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

Table Of Contents

Hypoparathyroidism - Pipeline Review, H1 2016
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
Chugai Pharmaceutical Co., Ltd. 13
Rare Disease Therapeutics, Inc. 14
Shire Plc 15
Hypoparathyroidism - Therapeutics Assessment 16
Assessment by Monotherapy Products 16
Assessment by Target 17
Assessment by Mechanism of Action 19
Assessment by Route of Administration 21
Assessment by Molecule Type 23
Drug Profiles 25
Eu-232 - Drug Profile 25
Product Description 25
Mechanism of Action 25
RandD Progress 25
parathyroid hormone - Drug Profile 26
Product Description 26
Mechanism of Action 26
RandD Progress 26
PCO-371 - Drug Profile 29
Product Description 29
Mechanism of Action 29
RandD Progress 29
teriparatide - Drug Profile 30
Product Description 30
Mechanism of Action 30
RandD Progress 30
teriparatide - Drug Profile 31
Product Description 31
Mechanism of Action 31
RandD Progress 31
Hypoparathyroidism - Recent Pipeline Updates 32
Hypoparathyroidism - Dormant Projects 35
Hypoparathyroidism - Product Development Milestones 36
Featured News and Press Releases 36
Jan 23, 2015: FDA approves Natpara to control low blood calcium levels in patients with hypoparathyroidism 36
Dec 02, 2014: European Medicines Agency Validates Marketing Authorization Application for Natpar (parathyroid hormone (rDNA)) in Hypoparathyroidism 37
Oct 23, 2014: PDUFA Action Date For Natpara BLA Extended Three Months To January 24, 2015 37
Sep 12, 2014: FDA Advisory Committee Recommends Approval of Natpara for Long-Term Treatment of Hypoparathyroidism 38
Sep 12, 2014: FDA Advisory Committee to Review Natpara Biologics License Application 38
Sep 10, 2014: FDA Posts Briefing Materials for Advisory Committee Meeting Reviewing Natpara for Hypoparathyroidism 38
Jul 24, 2014: PARADOX Findings Published in Endocrine Practice Describe High Burden of Illness in Patients with Hypoparathyroidism 39
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 40
Jan 07, 2014: NPS Pharmaceuticals Announces FDA Acceptance of Biologics License Application for Natpara for the Treatment of Hypoparathyroidism 40
Jan 03, 2014: NPS Pharmaceuticals Receives Orphan Drug Designation for Natpara in Europe 41
Appendix 42
Methodology 42
Coverage 42
Secondary Research 42
Primary Research 42
Expert Panel Validation 42
Contact Us 42
Disclaimer 43

List of Tables
Number of Products under Development for Hypoparathyroidism, H1 2016 7
Number of Products under Development by Companies, H1 2016 8
Comparative Analysis by Late Stage Development, H1 2016 9
Comparative Analysis by Clinical Stage Development, H1 2016 10
Comparative Analysis by Early Stage Development, H1 2016 11
Products under Development by Companies, H1 2016 12
Hypoparathyroidism - Pipeline by Chugai Pharmaceutical Co., Ltd., H1 2016 13
Hypoparathyroidism - Pipeline by Rare Disease Therapeutics, Inc., H1 2016 14
Hypoparathyroidism - Pipeline by Shire Plc, H1 2016 15
Assessment by Monotherapy Products, H1 2016 16
Number of Products by Stage and Target, H1 2016 18
Number of Products by Stage and Mechanism of Action, H1 2016 20
Number of Products by Stage and Route of Administration, H1 2016 22
Number of Products by Stage and Molecule Type, H1 2016 24
Hypoparathyroidism Therapeutics - Recent Pipeline Updates, H1 2016 32
Hypoparathyroidism - Dormant Projects, H1 2016 35

List of Figures
Number of Products under Development for Hypoparathyroidism, H1 2016 7
Number of Products under Development by Companies, H1 2016 8
Comparative Analysis by Clinical Stage Development, H1 2016 10
Assessment by Monotherapy Products, H1 2016 16
Number of Products by Targets, H1 2016 17
Number of Products by Stage and Targets, H1 2016 17
Number of Products by Mechanism of Actions, H1 2016 19
Number of Products by Stage and Mechanism of Actions, H1 2016 19
Number of Products by Routes of Administration, H1 2016 21
Number of Products by Stage and Routes of Administration, H1 2016 21
Number of Products by Molecule Types, H1 2016 23
Number of Products by Stage and Top 10 Molecule Types, H1 2016 23

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