There is a need for new therapies for heart failure, as disease rates remain high. Current prevalence estimates for chronic HF range from 1-2% of the population, totaling over 13m patients in 7 major markets. The prognosis for HF patients is poor, with 5 year mortality rates between 61-68% in the US and EU. Greater understanding of HF has opened the way for novel therapeutic approaches. The diverse R&D pipeline includes 32 compounds in 14 novel drug classes, with the involvement of 28 companies.

• Evaluates patient potential categorized by age, disease, severity, and etiology, including a segmentation of chronic and acute heart failure

  
  

• Reviews the role and limitations of existing drug and devices and provides in-depth analysis of compounds in novel developmental drug classes

  
  

Although the acute heart failure population represents a smaller market (1.2m hospitalizations in the US in 2002), it is a valid target for specialist niche companies due to the high level of unmet need.

Diastolic heart failure, representing between 17-30% of the chronic heart failure population in the US and EU, has been widely neglected to the detriment of patients and research into this area presents an opportunity for the pharmaceutical industry.

The late-stage HF pipeline is weak in terms of quantity and quality, with the combined revenue forecast for seven new compounds in 2010 is $2bn, provided they reach the market.

• Assesses the market appeal for R&D investment, providing an overview of developmental therapies, identifying promising candidates for in-licensing.

  
  

• Recognize key areas within the treatment of heart failure and heart failure sub-populations that remain inadequately served.

  
  

• Identify lucrative targets for developmental compounds, in terms of unmet need and patient potential, to successfully position developmental products.

  
  

• Access in-depth analyses of clinical and market factors together with forecasts for late-stage compounds in development for chronic and acute HF.

  
  

Current prevalence estimates for chronic heart failure range from 1-2% of the population across the seven major markets, totaling over 13m patients

The prognosis for heart failure patients remains poor and it is estimated that five year mortality rates range between 61-68% in the US and EU

Heart failure already represents the leading cause of hospitalization for patients over the age of 65 in Western markets and is therefore a significant economic burden for healthcare providers

The chapter discusses the clear need for new treatments for heart failure, as mortality and morbidity rates remain high.

Understand the demographics that shape the market in this highly-age dependent disease and the unmet needs identified by opinion leaders.

This chapter provides epidemiology data and forecasts for the chronic and acute heart failure population across seven markets, by age, severity and disease classification.

Reviews of existing therapies: ACE inhibitors, beta blockers, diuretics, digoxin, IV inotropes, recently launched IV drugs (Simdax and Natrecor), ICDs/cardiac resynchronization devices and LVADs

Identifies unmet needs in heart failure based on opinion leader interviews

Understand the mechanism of action and the R&D history of the following developmental drug classes: adenosine A1 receptor antagonists, AGE cross link breakers, cytokine antagonists, endothelin receptor antagonists, inhibitors of fatty acid oxidation, vasoendopeptidase inhibitors, selective aldosterone receptor antagonists, renin inhibitors, calcium sensitizers, phosphodieserase inhibitors, vasopressin antagonists, xanthine oxidase inhibitors and cell transplant technologies.

Recognize the perils and pitfalls of clinical trial design.

Datamonitor has identified 32 key developmental compounds in 14 drug classes or therapy approaches, with the involvement of 28 pharmaceutical and biotechnology companies.

This chapter provides a quantitative overview of drug development by class, phase and company involvement.

Which companies are currently developing heart failure therapies?

What drugs, drug classes and companies represent the most attractive licensing opportunities?

This chapter provides an in-depth analysis of clinical and competitive product attributes, as well as revenue forecasts until 2010 for the following late-stage drugs:

Eplerenone (Pharmacia/Pfizer);

Vanlev (Bristol-Myers Squibb);

Sitaxsentan (ICOS-Texas Biotechnology);

Veletri (Actelion/Genentech);

Oral enoximone (Myogen);

Oral levosimendan (Orion Pharmaceutical/Quintiles);

Nolomirole (Chiesi Farmaceutici).

Gain knowledge of phase II, phase I and preclinical compounds identified by Datamonitor as the most promising in development:

Vasopressin antagonists are well positioned to replace diuretics, one of the components in the standard four drug regimen and therefore represent one of the most promising class of early phase compounds in development for heart failure

Oral levosimendan has the potential to capture market share from IV inotropes and expand its patient potential to include patients with mild to moderate chronic HF;

Cell transplant technology pioneered by Bioheart and Diacrin is emerging as a significant potential alternative or complementary solution to existing drugs, devices and procedures used to treat patients with heart failure.

The Appendix contains details on sales forecasts and epidemiology methodology in seven major markets. A comprehensive list of all sources used throughout the report is also provided, including clinical trial papers and website links for key conferences and associations.

List of tables

Table 1: Key late-stage developmental agents in heart failure, 2002

Table 2: Prevalence of chronic heart failure in the seven major markets (1’000s), 2002- 2010

Table 3: Incidence of acute heart failure, 2002-2010

Table 4: Forecast sales of late-stage HF drugs, 2004-2010

Table 5: Epidemiological studies of etiology of HF

Table 6: New York Heart Association (NYHA) HF classes

Table 7: Breakdown of the chronic heart failure population by age in the seven major markets, 2002

Table 8: Co-morbidities observed in heart failure patients in the seven major markets, 2002

Table 9: Prevalence of chronic heart failure in the seven major markets (1’000s), 2002-2010

Table 10: Incidence of acute heart failure, 2002-2010

Table 11: Breakdown in the standard drug regimen prescribed to chronic HF patients, in the seven major markets, 2002

Table 12: Limitations of conventional drug therapies for HF

Table 13: Key clinical trials on the leading branded AIIRBs in chronic HF and/or post-MI patients, 2002

Table 14: Degree of patient compliance with chronic heart failure therapy, according to disease severity, in the seven major markets, 2002

Table 15: Key late-stage developmental agents in heart failure, 2002

Table 16: Breakdown of compounds by stage of development

Table 17: Probabilities of success for products at the end of each development stage

Table 18: Drug development by geographic company type and phase

Table 19: Company involvement in HF

Table 20: Key products in late-stage development for mild to moderate chronic HF

Table 21: IMPRESS trial efficacy endpoints

Table 22: IMPRESS trial: markers of renal dysfunction

Table 23: OVERTURE trial results

Table 24: OVERTURE trial: adverse events

Table 25: OVERTURE hospitalization endpoint re-analysis

Table 26: Forecast sales for Vanlev, 2004-2010

Table 27: Results of the 4E trial

Table 28: Forecast sales for eplerenone, 2004-2010

Table 29: Forecast sales for nolomirole, 2005-2010

Table 30: Key products in late-stage development for severe chronic HF and acute HF.

Table 31: Forecast sales for oral enoximone, 2004-2010

Table 32: Hemodynamic effects and mortality rates of IV levosimendan vs. dobutamine

Table 33: Forecast sales for oral levosimendan, 2007-2010

Table 34: Forecast sales for sitaxsentan, 2005-2010

Table 35: Forecast sales for Veletri, 2005-2010 163

Table 36: Late-stage discontinued/on hold compounds

Table 37: ENABLE: primary and secondary endpoints

Table 38: RECOVER and RENAISSANCE results

Table 39: ATTACH trial results

Table 40: Summary of EPOCH trial results

Table 41: Forecast sales of late-stage chronic HF drugs, 2004-2010

Table 42: Forecast sales of late-stage acute HF drugs, 2005-2010

Table 43: Forecast sales of late-stage acute and chronic HF drugs, 2004-2010

Table 44: Chronic and acute HF agents in early development, 2002

Table 45: Antidepressant market forecast, 2002–09

Table 46: Global sales forecasts for leading antidepressant drugs, 2002–09

Table 47: Confidence ratings for R&D pipeline data

Table 48: Phase III and registration anticonvulsant confidence ratings

Table 49: Phase II anticonvulsant confidence ratings

Table 50: Phase I anticonvulsant confidence ratings

Table 51: Preclinical and research anticonvulsant confidence ratings

Table 52: Estimated launch dates for forecasted products