Secondary Hyperparathyroidism - Pipeline Review, H2 2016

Published: Jul, 2016 | Pages: 57 | Publisher: Global Markets Direct
Industry: Pharmaceuticals & Healthcare | Report Format: Electronic (PDF)

Secondary Hyperparathyroidism - Pipeline Review, H2 2016

Summary

Global Markets Direct's, 'Secondary Hyperparathyroidism - Pipeline Review, H2 2016', provides an overview of the Secondary Hyperparathyroidism pipeline landscape. 

The report provides comprehensive information on the therapeutics under development for Secondary Hyperparathyroidism, 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 Secondary Hyperparathyroidism 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 Secondary Hyperparathyroidism
- The report reviews pipeline therapeutics for Secondary Hyperparathyroidism 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 Secondary Hyperparathyroidism therapeutics and enlists all their major and minor projects
- The report assesses Secondary Hyperparathyroidism 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 Secondary Hyperparathyroidism

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 Secondary Hyperparathyroidism
- 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 Secondary Hyperparathyroidism 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

Table of Contents 2
List of Tables 5
List of Figures 5
Introduction 6
Global Markets Direct Report Coverage 6
Secondary Hyperparathyroidism Overview 7
Therapeutics Development 8
Pipeline Products for Secondary Hyperparathyroidism - Overview 8
Secondary Hyperparathyroidism - Therapeutics under Development by Companies 9
Secondary Hyperparathyroidism - Pipeline Products Glance 10
Late Stage Products 10
Clinical Stage Products 11
Early Stage Products 12
Secondary Hyperparathyroidism - Products under Development by Companies 13
Secondary Hyperparathyroidism - Companies Involved in Therapeutics Development 14
Amgen Inc. 14
Deltanoid Pharmaceuticals Inc. 15
Mitsubishi Tanabe Pharma Corporation 16
OPKO Health, Inc. 17
Secondary Hyperparathyroidism - Therapeutics Assessment 18
Assessment by Monotherapy Products 18
Assessment by Target 19
Assessment by Mechanism of Action 21
Assessment by Route of Administration 23
Assessment by Molecule Type 25
Drug Profiles 27
Calcimimetic-18 - Drug Profile 27
Product Description 27
Mechanism Of Action 27
R&D Progress 27
CTA-091 - Drug Profile 28
Product Description 28
Mechanism Of Action 28
R&D Progress 28
CTAP-201 - Drug Profile 29
Product Description 29
Mechanism Of Action 29
R&D Progress 29
DP-001 - Drug Profile 30
Product Description 30
Mechanism Of Action 30
R&D Progress 30
etelcalcetide hydrochloride - Drug Profile 31
Product Description 31
Mechanism Of Action 31
R&D Progress 31
lunacalcipol - Drug Profile 36
Product Description 36
Mechanism Of Action 36
R&D Progress 36
MT-4580 - Drug Profile 38
Product Description 38
Mechanism Of Action 38
R&D Progress 38
VS-105 - Drug Profile 40
Product Description 40
Mechanism Of Action 40
R&D Progress 40
VS-110 - Drug Profile 41
Product Description 41
Mechanism Of Action 41
R&D Progress 41
VS-411 - Drug Profile 42
Product Description 42
Mechanism Of Action 42
R&D Progress 42
Secondary Hyperparathyroidism - Dormant Projects 43
Secondary Hyperparathyroidism - Discontinued Products 44
Secondary Hyperparathyroidism - Product Development Milestones 45
Featured News & Press Releases 45
May 24, 2016: ONO Announces Results from Phase 1/2 and Phase 3 Clinical Studies of "Etelcalcetide Hydrochloride (ONO-5163)" in Hemodialysis Patients with Secondary Hyperparathyroidism in Japan at ERA-EDTA Congress 45
Jan 26, 2016: Investigational Agent Shows Promise for SHPT in Hemodialysis Patients 45
Jan 14, 2016: ONO Submits Manufacturing and Marketing Approval Application in Japan for "Etelcalcetide Hydrochloride" (ONO-5163), a Calcimimetic Agent, for Secondary Hyperparathyroidism in Patients on Hemodialysis 46
Dec 01, 2015: Kyowa Hakko Kirin Announces Commencement of Phase 3 Clinical Study of KHK7580 in Patients with Secondary Hyperparathyroidism in Japan 46
Nov 07, 2015: Amgen Presents Detailed Data Comparing Etelcalcetide With Cinacalcet In Patients With Secondary Hyperparathyroidism Receiving Hemodialysis 47
Nov 06, 2015: FDA Accepts Amgen's New Drug Application For Novel Intravenous Calcimimetic Etelcalcetide 48
Sep 02, 2015: Amgen Submits Marketing Authorization Application For Novel Intravenous Calcimimetic Etelcalcetide (AMG 416) To The European Medicines Agency 49
Aug 25, 2015: Amgen Submits New Drug Application For Novel Intravenous Calcimimetic Etelcalcetide 49
May 29, 2015: Amgen Presents Pooled Phase 3 AMG 416 Data For The Treatment Of Secondary Hyperparathyroidism In Patients With Chronic Kidney Disease 50
Feb 25, 2015: Amgen Announces Positive Results From Head-To-Head Study Comparing The Efficacy And Safety Of AMG 416 With Cinacalcet In Patients With Secondary Hyperparathyroidism Receiving Hemodialysis 51
Oct 15, 2014: Deltanoid's DP001 (2MD) pharmaceutical demonstrated safe and effective in kidney failure patients on dialysis 52
Aug 29, 2014: Kyowa Hakko Kirin Announces Commencement of Phase 2b Clinical Study of KHK7580 in Patients with Secondary Hyperparathyroidism in Japan 53
Aug 18, 2014: Amgen Announces Positive Top-Line Results From Second Phase 3 Study Of AMG 416 For The Treatment Of Secondary Hyperparathyroidism In Patients With Chronic Kidney Disease Receiving Hemodialysis 53
Jan 06, 2012: KAI Pharmaceuticals Announces Initiation Of Second Phase II Study Of KAI-4169 54
Nov 14, 2011: KAI Announces Results from Phase II study of ONO-5163/KAI-4169, Calcium Sensing Receptor Agonist 54
Appendix 56
Methodology 56
Coverage 56
Secondary Research 56
Primary Research 56
Expert Panel Validation 56
Contact Us 56
Disclaimer 57

List of Tables

Number of Products under Development for Secondary Hyperparathyroidism, H2 2016 8
Number of Products under Development by Companies, H2 2016 9
Comparative Analysis by Late Stage Development, H2 2016 10
Comparative Analysis by Clinical Stage Development, H2 2016 11
Comparative Analysis by Early Stage Development, H2 2016 12
Products under Development by Companies, H2 2016 13
Secondary Hyperparathyroidism - Pipeline by Amgen Inc., H2 2016 14
Secondary Hyperparathyroidism - Pipeline by Deltanoid Pharmaceuticals Inc., H2 2016 15
Secondary Hyperparathyroidism - Pipeline by Mitsubishi Tanabe Pharma Corporation, H2 2016 16
Secondary Hyperparathyroidism - Pipeline by OPKO Health, Inc., H2 2016 17
Assessment by Monotherapy Products, H2 2016 18
Number of Products by Stage and Target, H2 2016 20
Number of Products by Stage and Mechanism of Action, H2 2016 22
Number of Products by Stage and Route of Administration, H2 2016 24
Number of Products by Stage and Molecule Type, H2 2016 26
Secondary Hyperparathyroidism - Dormant Projects, H2 2016 43
Secondary Hyperparathyroidism - Discontinued Products, H2 2016 44