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Secondary Hyperparathyroidism-Pipeline Review, H1 2015

Secondary Hyperparathyroidism-Pipeline Review, H1 2015


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Executive Summary

Secondary Hyperparathyroidism-Pipeline Review, H1 2015

Summary

Global Markets Direct's, 'Secondary Hyperparathyroidism-Pipeline Review, H1 2015', provides an overview of the Secondary Hyperparathyroidism's therapeutic pipeline.

This report provides comprehensive information on the therapeutic development for Secondary Hyperparathyroidism, complete with comparative analysis at various stages, therapeutics assessment by drug target, mechanism of action (MoA), route of administration (RoA) and molecule type, along with latest updates, and featured news and press releases. It also reviews key players involved in the therapeutic development for Secondary Hyperparathyroidism and special features on late-stage 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, SEC filings, investor presentations and featured press releases from company/university sites and industry-specific third party sources, put together by Global Markets Direct's team. Drug profiles/records featured in the report undergoes periodic updation following a stringent set of processes that ensures that all the profiles are updated with the latest set of information. Additionally, processes including live news & deals tracking, browser based alert-box and clinical trials registries tracking ensure that the most recent developments are captured on a real time basis.

The report enhances decision making capabilities and help to create effective counter strategies to gain competitive advantage. It strengthens R&D pipelines by identifying new targets and MOAs to produce first-in-class and best-in-class products.

Note*: Certain sections in the report may be removed or altered based on the availability and relevance of data for the indicated disease.

Scope

The report provides a snapshot of the global therapeutic landscape of Secondary Hyperparathyroidism

The report reviews key pipeline products under drug profile section which includes, product description, MoA and R&D brief, licensing and collaboration details & other developmental activities

The report reviews key players involved in the therapeutics development for Secondary Hyperparathyroidism and enlists all their major and minor projects

The report summarizes all the dormant and discontinued pipeline projects

A review of the Secondary Hyperparathyroidism products under development by companies and universities/research institutes based on information derived from company and industry-specific sources

Pipeline products coverage based on various stages of development ranging from pre-registration till discovery and undisclosed stages

A detailed assessment of monotherapy and combination therapy pipeline projects

Coverage of the Secondary Hyperparathyroidism pipeline on the basis of target, MoA, route of administration and molecule type

Latest news and deals relating related to pipeline products

Reasons To Buy

Provides strategically significant competitor information, analysis, and insights to formulate effective R&D development strategies

Identify emerging players with potentially strong product portfolio and create effective counter-strategies to gain competitive advantage

Develop strategic initiatives by understanding the focus areas of leading companies

Identify and understand important and diverse types of therapeutics under development for Secondary Hyperparathyroidism

Plan mergers and acquisitions effectively by identifying key players of the most promising pipeline

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

Pipeline Products for Secondary Hyperparathyroidism-Comparative Analysis 9

Secondary Hyperparathyroidism-Therapeutics under Development by Companies 10

Secondary Hyperparathyroidism-Pipeline Products Glance 11

Late Stage Products 11

Clinical Stage Products 12

Early Stage Products 13

Secondary Hyperparathyroidism-Products under Development by Companies 14

Secondary Hyperparathyroidism-Companies Involved in Therapeutics Development 15

Amgen Inc. 15

Astellas Pharma Inc. 16

Deltanoid Pharmaceuticals Inc. 17

Mitsubishi Tanabe Pharma Corporation 18

NPS Pharmaceuticals, Inc. 19

OPKO Health, Inc. 20

Secondary Hyperparathyroidism-Therapeutics Assessment 21

Assessment by Monotherapy Products 21

Assessment by Target 22

Assessment by Mechanism of Action 24

Assessment by Route of Administration 26

Assessment by Molecule Type 28

Drug Profiles 30

ASP-7991-Drug Profile 30

Product Description 30

Mechanism of Action 30

R&D Progress 30

calcifediol-Drug Profile 31

Product Description 31

Mechanism of Action 31

R&D Progress 31

Calcimimetic-18-Drug Profile 33

Product Description 33

Mechanism of Action 33

R&D Progress 33

CARD-024-Drug Profile 34

Product Description 34

Mechanism of Action 34

R&D Progress 34

cinacalcet hydrochloride-Drug Profile 36

Product Description 36

Mechanism of Action 36

R&D Progress 36

CTA-091-Drug Profile 38

Product Description 38

Mechanism of Action 38

R&D Progress 38

CTAP-201-Drug Profile 39

Product Description 39

Mechanism of Action 39

R&D Progress 39

DP-001-Drug Profile 40

Product Description 40

Mechanism of Action 40

R&D Progress 40

lunacalcipol-Drug Profile 42

Product Description 42

Mechanism of Action 42

R&D Progress 42

MT-4580-Drug Profile 44

Product Description 44

Mechanism of Action 44

R&D Progress 44

velcalcetide-Drug Profile 45

Product Description 45

Mechanism of Action 45

R&D Progress 45

VS-105-Drug Profile 47

Product Description 47

Mechanism of Action 47

R&D Progress 47

VS-110-Drug Profile 48

Product Description 48

Mechanism of Action 48

R&D Progress 48

VS-411-Drug Profile 49

Product Description 49

Mechanism of Action 49

R&D Progress 49

Secondary Hyperparathyroidism-Recent Pipeline Updates 50

Secondary Hyperparathyroidism-Dormant Projects 59

Secondary Hyperparathyroidism-Product Development Milestones 60

Featured News & Press Releases 60

Oct 15, 2014: Deltanoid's DP001 (2MD) pharmaceutical demonstrated safe and effective in kidney failure patients on dialysis 60

Sep 23, 2014: OPKO's Second Rayaldee Phase 3 Trial Meets Primary Endpoints 60

Aug 29, 2014: Kyowa Hakko Kirin Announces Commencement of Phase 2b Clinical Study of KHK7580 in Patients with Secondary Hyperparathyroidism in Japan 62

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 62

Aug 11, 2014: Rayaldee Phase 3 Trial Meets Primary Endpoints 63

Aug 07, 2014: OPKO Submits IND for Rayaldee as Adjunctive Cancer Therapy 64

Jul 22, 2014: OPKO Granted Patent from US Patent & Trademark Office for RAYALDEE 65

Dec 19, 2013: OPKO Completes Patient Recruitment in Second Phase 3 Trial of Rayaldy 65

Aug 15, 2013: OPKO Surpasses 50% Enrollment in Second Phase 3 Trial of Rayaldy 66

Jun 27, 2013: Kyowa Hakko Kirin Files Application Seeking Approval For Additional Indication For Regpara Tablets 25mg And 75mg 67

Appendix 68

Methodology 68

Coverage 68

Secondary Research 68

Primary Research 68

Expert Panel Validation 68

Contact Us 69

Disclaimer 69

List of Tables

Number of Products under Development for Secondary Hyperparathyroidism, H1 2015 8

Number of Products under Development for Secondary Hyperparathyroidism-Comparative Analysis, H1 2015 9

Number of Products under Development by Companies, H1 2015 10

Comparative Analysis by Late Stage Development, H1 2015 11

Comparative Analysis by Clinical Stage Development, H1 2015 12

Comparative Analysis by Early Stage Development, H1 2015 13

Products under Development by Companies, H1 2015 14

Secondary Hyperparathyroidism-Pipeline by Amgen Inc., H1 2015 15

Secondary Hyperparathyroidism-Pipeline by Astellas Pharma Inc., H1 2015 16

Secondary Hyperparathyroidism-Pipeline by Deltanoid Pharmaceuticals Inc., H1 2015 17

Secondary Hyperparathyroidism-Pipeline by Mitsubishi Tanabe Pharma Corporation, H1 2015 18

Secondary Hyperparathyroidism-Pipeline by NPS Pharmaceuticals, Inc., H1 2015 19

Secondary Hyperparathyroidism-Pipeline by OPKO Health, Inc., H1 2015 20

Assessment by Monotherapy Products, H1 2015 21

Number of Products by Stage and Target, H1 2015 23

Number of Products by Stage and Mechanism of Action, H1 2015 25

Number of Products by Stage and Route of Administration, H1 2015 27

Number of Products by Stage and Molecule Type, H1 2015 29

Secondary Hyperparathyroidism Therapeutics-Recent Pipeline Updates, H1 2015 50

Secondary Hyperparathyroidism-Dormant Projects, H1 2015 59

List of Figures

Number of Products under Development for Secondary Hyperparathyroidism, H1 2015 8

Number of Products under Development for Secondary Hyperparathyroidism-Comparative Analysis, H1 2015 9

Number of Products under Development by Companies, H1 2015 10

Comparative Analysis by Clinical Stage Development, H1 2015 12

Comparative Analysis by Early Stage Products, H1 2015 13

Assessment by Monotherapy Products, H1 2015 21

Number of Products by Top 10 Targets, H1 2015 22

Number of Products by Stage and Top 10 Targets, H1 2015 23

Number of Products by Top 10 Mechanism of Actions, H1 2015 24

Number of Products by Stage and Top 10 Mechanism of Actions, H1 2015 25

Number of Products by Top 10 Routes of Administration, H1 2015 26

Number of Products by Stage and Top 10 Routes of Administration, H1 2015 27

Number of Products by Top 10 Molecule Types, H1 2015 28

Number of Products by Stage and Top 10 Molecule Types, H1 2015 29

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Amgen Inc.

Astellas Pharma Inc.

Deltanoid Pharmaceuticals Inc.

Mitsubishi Tanabe Pharma Corporation

NPS Pharmaceuticals, Inc.

OPKO Health, Inc.

Secondary Hyperparathyroidism Therapeutic Products under Development, Key Players in Secondary Hyperparathyroidism Therapeutics, Secondary Hyperparathyroidism Pipeline Overview, Secondary Hyperparathyroidism Pipeline, Secondary Hyperparathyroidism Pipeline Assessment


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