Acute Heart Failure – Pipeline Review, H2 2016

Global Markets Direct’s, ‘Acute Heart Failure – Pipeline Review, H2 2016’, provides an overview of the Acute Heart Failure pipeline landscape.

The report provides comprehensive information on the therapeutics under development for Acute Heart Failure, 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 Acute Heart Failure 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 Acute Heart Failure

The report reviews pipeline therapeutics for Acute Heart Failure 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 Acute Heart Failure therapeutics and enlists all their major and minor projects

The report assesses Acute Heart Failure 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 Acute Heart Failure

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 Acute Heart Failure

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 Acute Heart Failure 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

Companies mentioned

Amgen Inc.

Capricor Therapeutics, Inc.

Eli Lilly and Company

Lee's Pharmaceutical Holdings Limited

Novartis AG

Ono Pharmaceutical Co., Ltd.

PhaseBio Pharmaceuticals, Inc.

Trevena, Inc.

Table of Contents

Table of Contents

Table of Contents 2

List of Tables 5

List of Figures 5

Introduction 6

Global Markets Direct Report Coverage 6

Acute Heart Failure Overview 7

Therapeutics Development 8

Pipeline Products for Acute Heart Failure - Overview 8

Acute Heart Failure - Therapeutics under Development by Companies 9

Acute Heart Failure - Pipeline Products Glance 10

Late Stage Products 10

Clinical Stage Products 11

Early Stage Products 12

Acute Heart Failure - Products under Development by Companies 13

Acute Heart Failure - Companies Involved in Therapeutics Development 14

Amgen Inc. 14

Capricor Therapeutics, Inc. 15

Eli Lilly and Company 16

Lee's Pharmaceutical Holdings Limited 17

Novartis AG 18

Ono Pharmaceutical Co., Ltd. 19

PhaseBio Pharmaceuticals, Inc. 20

Trevena, Inc. 21

Acute Heart Failure - Therapeutics Assessment 22

Assessment by Monotherapy Products 22

Assessment by Target 23

Assessment by Mechanism of Action 25

Assessment by Route of Administration 27

Assessment by Molecule Type 29

Drug Profiles 31

cenderitide - Drug Profile 31

Product Description 31

Mechanism Of Action 31

R&D Progress 31

istaroxime - Drug Profile 34

Product Description 34

Mechanism Of Action 34

R&D Progress 34

omecamtiv mecarbil MR - Drug Profile 36

Product Description 36

Mechanism Of Action 36

R&D Progress 36

ONO-4232 - Drug Profile 43

Product Description 43

Mechanism Of Action 43

R&D Progress 43

PB-1046 - Drug Profile 44

Product Description 44

Mechanism Of Action 44

R&D Progress 44

ruboxistaurin - Drug Profile 46

Product Description 46

Mechanism Of Action 46

R&D Progress 46

serelaxin - Drug Profile 48

Product Description 48

Mechanism Of Action 48

R&D Progress 48

TRV-120023 - Drug Profile 52

Product Description 52

Mechanism Of Action 52

R&D Progress 52

ularitide - Drug Profile 53

Product Description 53

Mechanism Of Action 53

R&D Progress 53

Acute Heart Failure - Dormant Projects 55

Acute Heart Failure - Discontinued Products 56

Acute Heart Failure - Product Development Milestones 57

Featured News & Press Releases 57

Dec 11, 2015: Cardiorentis' Ularitide Receives FDA Fast Track Designation for the Treatment of Acute Decompensated Heart Failure 57

May 22, 2015: Cardiorentis Completes Enrollment in Pivotal Phase III Clinical Trial of Ularitide for Acute Heart Failure 57

Oct 16, 2014: Cardiorentis AG and Roche Announce Collaboration to Establish Therapeutic Impact of Ularitide 58

Oct 09, 2014: Capricor Therapeutics Announces Plans to Pursue a Cenderitide Clinical Program and Enters Into Research Support Agreement With Insulet Corporation 58

May 23, 2014: Novartis provides update on EU marketing authorization application for RLX030 in acute heart failure 59

May 16, 2014: FDA issues Complete Response Letter for RLX030 for acute heart failure 59

Mar 27, 2014: Novartis to work with FDA on path forward for RLX030 for acute heart failure following Advisory Committee outcome 60

Mar 25, 2014: FDA Staff Says Novartis’ Serelaxin Shouldn’t Be Approved 60

Jan 24, 2014: Novartis Europharm's Reasanz Receives CHMP Negative Opinion 61

Jan 24, 2014: Novartis to request re-examination of serelaxin in acute heart failure for conditional marketing authorization in EU 62

Dec 02, 2013: Paladin Announces Filing of New Drug Submission for RLX030 (Serelaxin) 63

Sep 03, 2013: Amgen And Cytokinetics Announce The First Presentation Of Data From Phase 2 ATOMIC-AHF Study Of Omecamtiv Mecarbil 63

Sep 02, 2013: Novartis' serelaxin improved symptoms and mortality across multiple subgroups of patients with acute heart failure 65

Jun 21, 2013: Novartis's Serelaxin Receives FDA Breakthrough Therapy Designation For Acute Heart Failure 66

Mar 18, 2013: Cytokinetics Announces Update To Heart Failure Program 66

Appendix 69

Methodology 69

Coverage 69

Secondary Research 69

Primary Research 69

Expert Panel Validation 69

Contact Us 69

Disclaimer 70

List of Tables

List of Tables

Number of Products under Development for Acute Heart Failure, 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

Acute Heart Failure – Pipeline by Amgen Inc., H2 2016 14

Acute Heart Failure – Pipeline by Capricor Therapeutics, Inc., H2 2016 15

Acute Heart Failure – Pipeline by Eli Lilly and Company, H2 2016 16

Acute Heart Failure – Pipeline by Lee's Pharmaceutical Holdings Limited, H2 2016 17

Acute Heart Failure – Pipeline by Novartis AG, H2 2016 18

Acute Heart Failure – Pipeline by Ono Pharmaceutical Co., Ltd., H2 2016 19

Acute Heart Failure – Pipeline by PhaseBio Pharmaceuticals, Inc., H2 2016 20

Acute Heart Failure – Pipeline by Trevena, Inc., H2 2016 21

Assessment by Monotherapy Products, H2 2016 22

Number of Products by Stage and Target, H2 2016 24

Number of Products by Stage and Mechanism of Action, H2 2016 26

Number of Products by Stage and Route of Administration, H2 2016 28

Number of Products by Stage and Molecule Type, H2 2016 30

Acute Heart Failure – Dormant Projects, H2 2016 55

Acute Heart Failure – Discontinued Products, H2 2016 56

List of Figures

List of Figures

Number of Products under Development for Acute Heart Failure, H2 2016 8

Number of Products under Development by Companies, H2 2016 9

Comparative Analysis by Clinical Stage Development, H2 2016 11

Assessment by Monotherapy Products, H2 2016 22

Number of Products by Top 10 Targets, H2 2016 23

Number of Products by Stage and Top 10 Targets, H2 2016 23

Number of Products by Top 10 Mechanism of Actions, H2 2016 25

Number of Products by Stage and Top 10 Mechanism of Actions, H2 2016 25

Number of Products by Routes of Administration, H2 2016 27

Number of Products by Stage and Routes of Administration, H2 2016 27

Number of Products by Molecule Types, H2 2016 29

Number of Products by Stage and Molecule Types, H2 2016 29

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