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Secondary Hyperparathyroidism - Pipeline Review, H1 2016

  • February 2016
  • -
  • Global Markets Direct
  • -
  • 64 pages

Secondary Hyperparathyroidism - Pipeline Review, H1 2016

Summary

Global Markets Direct’s, ‘Secondary Hyperparathyroidism - Pipeline Review, H1 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

Secondary Hyperparathyroidism - Pipeline Review, H1 2016
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
Nektar Therapeutics 17
OPKO Health, Inc. 18
Secondary Hyperparathyroidism - Therapeutics Assessment 19
Assessment by Monotherapy Products 19
Assessment by Target 20
Assessment by Mechanism of Action 22
Assessment by Route of Administration 24
Assessment by Molecule Type 26
Drug Profiles 28
calcifediol MR - Drug Profile 28
Product Description 28
Mechanism of Action 28
RandD Progress 28
Calcimimetic-18 - Drug Profile 30
Product Description 30
Mechanism of Action 30
RandD Progress 30
CTA-091 - Drug Profile 31
Product Description 31
Mechanism of Action 31
RandD Progress 31
CTAP-201 - Drug Profile 32
Product Description 32
Mechanism of Action 32
RandD Progress 32
DP-001 - Drug Profile 33
Product Description 33
Mechanism of Action 33
RandD Progress 33
Drugs to Inhibit CYP24 for Secondary Hyperparathyroidism, Chronic Kidney Disease and Oncology - Drug Profile 35
Product Description 35
Mechanism of Action 35
RandD Progress 35
etelcalcetide hydrochloride - Drug Profile 36
Product Description 36
Mechanism of Action 36
RandD Progress 36
lunacalcipol - Drug Profile 38
Product Description 38
Mechanism of Action 38
RandD Progress 38
MT-4580 - Drug Profile 40
Product Description 40
Mechanism of Action 40
RandD Progress 40
NKTR-228 - Drug Profile 41
Product Description 41
Mechanism of Action 41
RandD Progress 41
VS-105 - Drug Profile 42
Product Description 42
Mechanism of Action 42
RandD Progress 42
VS-110 - Drug Profile 43
Product Description 43
Mechanism of Action 43
RandD Progress 43
VS-411 - Drug Profile 44
Product Description 44
Mechanism of Action 44
RandD Progress 44
Secondary Hyperparathyroidism - Recent Pipeline Updates 45
Secondary Hyperparathyroidism - Dormant Projects 55
Secondary Hyperparathyroidism - Discontinued Products 56
Secondary Hyperparathyroidism - Product Development Milestones 57
Featured News and Press Releases 57
Jan 26, 2016: Investigational Agent Shows Promise for SHPT in Hemodialysis Patients 57
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 57
Dec 01, 2015: Kyowa Hakko Kirin Announces Commencement of Phase 3 Clinical Study of KHK7580 in Patients with Secondary Hyperparathyroidism in Japan 58
Nov 07, 2015: Amgen Presents Detailed Data Comparing Etelcalcetide With Cinacalcet In Patients With Secondary Hyperparathyroidism Receiving Hemodialysis 58
Nov 06, 2015: FDA Accepts Amgen's New Drug Application For Novel Intravenous Calcimimetic Etelcalcetide 59
Nov 05, 2015: Additional Phase 3 Data Supporting OPKO's Rayaldee as a Treatment for Secondary Hyperparathyroidism in Chronic Kidney Disease to be Presented at Kidney Week 2015 60
Sep 02, 2015: Amgen Submits Marketing Authorization Application For Novel Intravenous Calcimimetic Etelcalcetide (AMG 416) To The European Medicines Agency 60
Aug 25, 2015: Amgen Submits New Drug Application For Novel Intravenous Calcimimetic Etelcalcetide 61
Aug 03, 2015: Catalent's OptiShell Technology Is Delivery Platform For Opko Health's New Chronic Kidney Disease Treatment 61
Jul 28, 2015: FDA Accepts OPKO's New Drug Application for Rayaldee 62
Appendix 63
Methodology 63
Coverage 63
Secondary Research 63
Primary Research 63
Expert Panel Validation 63
Contact Us 63
Disclaimer 64

List of Tables
Number of Products under Development for Secondary Hyperparathyroidism, H1 2016 8
Number of Products under Development by Companies, H1 2016 9
Comparative Analysis by Late Stage Development, H1 2016 10
Comparative Analysis by Clinical Stage Development, H1 2016 11
Comparative Analysis by Early Stage Development, H1 2016 12
Products under Development by Companies, H1 2016 13
Secondary Hyperparathyroidism - Pipeline by Amgen Inc., H1 2016 14
Secondary Hyperparathyroidism - Pipeline by Deltanoid Pharmaceuticals Inc., H1 2016 15
Secondary Hyperparathyroidism - Pipeline by Mitsubishi Tanabe Pharma Corporation, H1 2016 16
Secondary Hyperparathyroidism - Pipeline by Nektar Therapeutics, H1 2016 17
Secondary Hyperparathyroidism - Pipeline by OPKO Health, Inc., H1 2016 18
Assessment by Monotherapy Products, H1 2016 19
Number of Products by Stage and Target, H1 2016 21
Number of Products by Stage and Mechanism of Action, H1 2016 23
Number of Products by Stage and Route of Administration, H1 2016 25
Number of Products by Stage and Molecule Type, H1 2016 27
Secondary Hyperparathyroidism Therapeutics - Recent Pipeline Updates, H1 2016 45
Secondary Hyperparathyroidism - Dormant Projects, H1 2016 55
Secondary Hyperparathyroidism - Discontinued Products, H1 2016 56

List of Figures
Number of Products under Development for Secondary Hyperparathyroidism, H1 2016 8
Number of Products under Development by Companies, H1 2016 9
Comparative Analysis by Late Stage Development, H1 2016 10
Assessment by Monotherapy Products, H1 2016 19
Number of Products by Targets, H1 2016 20
Number of Products by Stage and Targets, H1 2016 20
Number of Products by Mechanism of Actions, H1 2016 22
Number of Products by Stage and Mechanism of Actions, H1 2016 22
Number of Products by Routes of Administration, H1 2016 24
Number of Products by Stage and Routes of Administration, H1 2016 24
Number of Products by Molecule Types, H1 2016 26
Number of Products by Stage and Molecule Types, H1 2016 26

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