Hypoparathyroidism - Pipeline Review, H2 2016

Published: Nov, 2016 | Pages: 51 | Publisher: Global Markets Direct
Industry: Pharmaceuticals & Healthcare | Report Format: Electronic (PDF)

Summary

Global Markets Direct's latest Pharmaceutical and Healthcare disease pipeline guide Hypoparathyroidism - Pipeline Review, H2 2016, provides an overview of the Hypoparathyroidism (Hormonal Disorders) pipeline landscape.

Hypoparathyroidism is decreased function of the parathyroid glands with underproduction of parathyroid hormone. This leads to low levels of calcium in the blood, often causing cramping and twitching of muscles (involuntary muscle contraction), and several other symptoms. The condition can be inherited, but it is also encountered after thyroid or parathyroid gland surgery, and it can be caused by immune system-related damage as well as a number of rarer causes. The treatment includes artificial form of the hormone that can be administered as replacement, calcium replacement or vitamin.

Report Highlights

Global Markets Direct's Pharmaceutical and Healthcare latest pipeline guide Hypoparathyroidism - Pipeline Review, H2 2016, provides comprehensive information on the therapeutics under development for Hypoparathyroidism (Hormonal Disorders), complete with analysis by stage of development, drug target, mechanism of action (MoA), route of administration (RoA) and molecule type. The guide covers the descriptive pharmacological action of the therapeutics, its complete research and development history and latest news and press releases.

The Hypoparathyroidism (Hormonal Disorders) pipeline guide also reviews of key players involved in therapeutic development for Hypoparathyroidism and features dormant and discontinued projects. The guide covers therapeutics under Development by Companies /Universities /Institutes, the molecules developed by Companies in Pre-Registration, Phase II, Phase I and Preclinical stages are 1, 1, 1 and 4 respectively.Hypoparathyroidism.

Hypoparathyroidism (Hormonal Disorders) pipeline guide 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. The guide 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. Additionally, various dynamic tracking processes ensure that the most recent developments are captured on a real time basis.

Note: Certain content / sections in the pipeline guide may be removed or altered based on the availability and relevance of data.

Scope

- The pipeline guide provides a snapshot of the global therapeutic landscape of Hypoparathyroidism (Hormonal Disorders).
- The pipeline guide reviews pipeline therapeutics for Hypoparathyroidism (Hormonal Disorders) by companies and universities/research institutes based on information derived from company and industry-specific sources.
- The pipeline guide covers pipeline products based on several stages of development ranging from pre-registration till discovery and undisclosed stages.
- The pipeline guide features descriptive drug profiles for the pipeline products which comprise, product description, descriptive licensing and collaboration details, R&D brief, MoA & other developmental activities.
- The pipeline guide reviews key companies involved in Hypoparathyroidism (Hormonal Disorders) therapeutics and enlists all their major and minor projects.
- The pipeline guide evaluates Hypoparathyroidism (Hormonal Disorders) therapeutics based on mechanism of action (MoA), drug target, route of administration (RoA) and molecule type.
- The pipeline guide encapsulates all the dormant and discontinued pipeline projects.
- The pipeline guide reviews latest news related to pipeline therapeutics for Hypoparathyroidism (Hormonal Disorders)

Reasons To Buy

- Procure strategically important competitor information, analysis, and insights to formulate effective R&D strategies.
- Recognize emerging players with potentially strong product portfolio and create effective counter-strategies to gain competitive advantage.
- Find and recognize significant and varied types of therapeutics under development for Hypoparathyroidism (Hormonal Disorders).
- Classify potential new clients or partners in the target demographic.
- Develop tactical initiatives by understanding the focus areas of leading companies.
- Plan mergers and acquisitions meritoriously by identifying key players and it's most promising pipeline therapeutics.
- Formulate corrective measures for pipeline projects by understanding Hypoparathyroidism (Hormonal Disorders) 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.
- Adjust the therapeutic portfolio by recognizing discontinued projects and understand from the know-how what drove them from pipeline.

 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

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