Market Report Source

Overview

Introduction
Datamonitor expects few new products to emerge from a week pipeline for both acute and chronic heart failure. Sales in the seven major markets will be modest with all the new drugs being add-on therapies to current standard regimes. Significant unmet patients needs will remain in both acute and chronic heart failure.

Scope

• Comprehensive analysis of the current acute and chronic heart failure pipeline detailing the broad of developmental classes
• A detailed clinical and commercial assessment of all key emerging therapies
• Epidemiological based sales forecasts for key late-stage developmental heart failure agents in the seven major markets to 2016

Highlights
The heart failure market is relatively stable, with few drugs being launched in the past five years and many of those launched having significant safety or commercial viability issues. It is also a market with high unmet need waiting to be addressed. Patients with heart failure have a poor prognosis with half of all patients diagnosed with severe heart failure dying within four years. The R&D pipeline for heart failure is a Phase II-heavy, diverse range of novel agents, with 50% all of candidates being in Phase II trials.

Reasons to Purchase

• Quantify the future drugs in the acute and chronic heart failure market
• Identify licensing opportunities based on company portfolio and market needs
• Assess the remaining market opportunity, where established therapies and other developmental compounds fail to address key unmet clinical needs.

Table of Contents

CHAPTER 1 EXECUTIVE SUMMARY

Scope of the analysis

Datamonitor insight into the heart failure disease market

Key metrics

Datamonitor Pipeline Assessment Summary

Related reports

CHAPTER 2 PIPELINE OVERVIEW AND DYNAMICS

Heart failure: a diverse pipeline

Greatest number of candidates in Phase II of development

High attrition rate within the pipeline

Market not dominated by one company

Key R&D company strategies

Expanded indications for approved drugs

Niche patient subgroups

CHAPTER 3 HEART FAILURE OVERVIEW – MARKET POTENTIAL

Definition of Heart Failure

Acute heart failure

Chronic heart failure

Etiology of heart failure

Segmentation of heart failure

Disease severity

Low versus high output failure

Systolic versus diastolic heart failure

Age group

Co-morbidities, complications and risk factors

Anemia: an emerging risk factor in chronic heart failure

Erythropoietin in the treatment of anemia in chronic heart failure

Devices and surgery: treatments for end-point heart failure

Cardiac devices

Cardiac resynchronization therapy (CRT)

Implantable cardioverter defibrillators (ICD)

Ventricular Assist Devices (VAD)

Total artificial heart

Novel devices under development

Surgery

Heart transplantation

Telemedicine (Disease management)

Epidemiology of heart failure

Future incidence of acute heart failure

Future prevalence of chronic heart failure

Future trends in the incidence and prevalence of heart failure

Unmet need in heart failure

Acute heart failure

Unmet need 1: increased efficacy

Unmet need 2: drugs with novel mechanisms of action

Unmet need 3: reduced length of hospital stay/ re-hospitalization

Unmet need 4: improved safety profile

Unmet need 5: increased mortality benefit

Chronic heart failure

Unmet need 1: targeting niche markets

Unmet need 2: increased efficacy

Unmet need 3: increased compliance

Unmet need 4: increased safety profile

Unmet need 5: ability to halt or reverse the progression of the disease

Unmet need 6: drugs with novel mechanisms of action

CHAPTER 4 R&D APPROACH

Classification of pipeline products

Acute heart failure

Potassium channel activator/nitric oxide donor

Vasopressin V2 antagonists

Preclinical and clinical progress

Adenosine A1 antagonists

Preclinical and clinical progress

Atrial natriuretic peptide (ANP) agonists

Preclinical and clinical progress

Endothelin ET-A antagonists

Preclinical and clinical progress

Cardiac myosin activators

Preclinical and clinical progress

CRF-R2 agonists

Preclinical and clinical progress

Na+/K+ ATPase inhibitors

Preclinical and clinical progress

ORL-1 agonists

Preclinical and clinical progress

Soluble guanylate cyclase modulators

Preclinical and clinical progress

Chronic heart failure

Angiotensin II antagonists

Clinical progress

Adenosine A1 antagonists

Preclinical and clinical progress

Renin inhibitors

Preclinical and clinical progress

HMG CoA reductase inhibitors (statins)

Preclinical and clinical progress

Immunotherapy

Preclinical and clinical progress

Chelating agents

Preclinical and clinical progress

Brain natriuretic protein (BNP) agonists

Preclinical and clinical progress

Dual NEP/ECE inhibitors

Preclinical and clinical progress

Sino-atrial node inhibitors

Preclinical and clinical progress

Endothelial nitric oxide synthase (eNOS) transcription enhancer

Preclinical and clinical progress

Chymase inhibitors

Preclinical and clinical progress

AGE crosslink breakers

Preclinical and clinical progress

Undefined heart failure

Myoblast cell therapy

Preclinical and clinical progress

agonists?PPAR

Preclinical and clinical progress

Relaxin agonists

Preclinical and clinical progress

SERCA 2a gene therapy

Preclinical and clinical progress

CGRP agonists

Preclinical and clinical progress

Clinical trial design in heart failure

Comparators: add-on versus replacement therapy

Clinical trials endpoints in heart failure

Use of surrogate endpoints

Trials in acute heart failure

True endpoints

Surrogate endpoints

Trials in chronic heart failure

True endpoints

Surrogate endpoints

CHAPTER 5 ACUTE HEART FAILURE LATE-STAGE DRUG ANALYSIS AND FORECASTS

Overview for acute heart failure

Pipeline summary

Comparative forecasts

Definition of current comparator therapy

Oral diuretics

Nitrates

Inotropic agents

Vasodilators

Tolvaptan

Drug overview

Clinical data

Ongoing clinical trials

Completed trials

EVEREST

SALT-1 and SALT-2

Patient potential

Marketing factors

Satisfaction of unmet needs

SWOT analysis

Forecasts to 2016

Datamonitor drug assessment summary

Ularitide (urodilatin)

Drug overview

Clinical trial data

SIRIUS II

Patient potential

Marketing factors

Satisfaction of unmet needs

SWOT analysis

Forecasts to 2016

Datamonitor drug assessment summary

KW-3902

Drug overview

Ongoing clinical trials

REACH UP

PROTECT-1 and PROTECT-2

Patient potential

Marketing factors

Satisfaction of unmet needs

SWOT analysis

Forecasts to 2016

Datamonitor drug assessment summary

Other drugs in acute heart failure

CK-1827452 (CK-452)

Drug profile

Clinical data

Sitaxentan (Thelin)

Restarting of clinical trials

Urocortin II

Drug profile

Clinical data

Istaroxime (PST-2744)

Drug profile

Clinical data

ZP-120

Drug profile

Innovative early-stage projects

TBC-3711

Drug overview

Preclinical data

BAY-58-2667

Drug overview

Preclinical development

Late-stage development compounds recently discontinued

Levosimendan (Simdax)

Carperitide (HANP)

CHAPTER 6 CHRONIC HEART FAILURE LATE-STAGE DRUG ANALYSIS AND FORECASTS

Overview for chronic heart failure

Pipeline summary

Comparative forecasts

Definition of comparator therapy

Chronic heart failure ‘gold standard’

Irbesartan (Aprovel)

Drug overview

Clinical trial data

Ongoing clinical trials

Patient potential

Marketing factors

Satisfaction of unmet needs

SWOT analysis

Forecasts to 2016

Datamonitor drug assessment summary

Aliskiren (Tekturna)

Drug overview

Ongoing clinical trials

ALOFT

ASPIRE

NCT00409578

Patient potential

Marketing factors

Satisfaction of unmet needs

SWOT analysis

Forecasts to 2016

Datamonitor drug assessment summary

Rosuvastatin (Crestor)

Drug overview

Ongoing clinical trials

CORONA

NCT00176332

GISSI-HF

Patient potential

Marketing factors

Satisfaction of unmet needs

SWOT analysis

Forecasts to 2016

Datamonitor drug assessment summary

Celacade (VAS-991)

Drug overview

Clinical data

ACCLAIM

Patient potential

Marketing factors

Satisfaction of unmet needs

SWOT analysis

Forecasts to 2016

Datamonitor drug assessment summary

Other drugs in chronic heart failure

Trientine

Drug overview

Clinical data

CG-77X56 (Cardeva)

Drug overview

Daglutril

Drug overview

Clinical data

BG-9928

Drug overview

Clinical data