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Cardiovascular Disease:
A Review of Biomarkers, Surrogate Endpoints and Therapeutic Options

· 122 pages   · 17 Exhibits   · October 2004   · Report #C225

Atherosclerotic vascular disease is among the most frequent causes of death worldwide. It is the consequence of complex interactions between many pathogenic mechanisms including alterations in lipoprotein metabolism, fibrinolysis, coagulation, and vessel-wall structure. Current therapeutic strategies have historically concentrated mainly on lowering low-density lipoprotein (LDL) cholesterol and an impressive reduction in the risk for cardiovascular morbidity and mortality has been achieved. Inflammatory mechanisms are more and more recognized to play an important role in vascular disease as inflammatory markers correlate with prognosis in acute and chronic coronary artery disease. This shift in focus comes as a byproduct of extensive research in vascular biology which has clearly demonstrated that inflammation can play a vital role in the initiation, maintenance and/or progression of atherosclerosis.

Efforts are underway to address this underlying inflammation through the development of novel therapeutic candidates. Moreover, alternative therapeutic interventions must also be considered which include addressing the well recognized pleiotropic effects of HDL insofar as they are known to include anti-inflammatory, anti-oxidant, anti-thrombogenic and ameliorative lipid effects. The improved characterization of inducible inflammatory modulators and vital metabolic regulators make many of these molecules amenable to pharmaceutical manipulation which may offer new perspectives in disease treatment, especially if undesirable side effects can be avoided. Forward looking R&D efforts have also considered the future need for surrogate markers for these modulators that will expedite FDA approval and commercialization efforts. Certainly the characterization of many of these metabolic pathways has pointed to a plethora of new biomarkers which may facilitate the assessment of pharmacological effects and hopefully correspond to therapeutic efficacy and predictable clinical outcomes. Hence, this is a new era for both therapeutics and surrogate markers which together could significantly impact on treatment strategies in cardiovascular disease.

This report is a detailed review of the range of current and emerging biomarkers used in the diagnosis and ongoing evaluation of atherosclerotic disease, the evaluation of the clinical impact of candidate pharmacologics and the evaluation of the impact of pharmacologics in the routine clinical management of atherosclerotic disease.  The report also examines the underlying pathologies and the relationships between a variety of associated disease states (metabolic syndrome, obesity, dyslipidemias, diabetes, hypertension, cardiovascular disease, atherosclerosis, and coagulopathies. The report examines the range of cardiovascular therapeutics including those currently on the market and those under development, detailing the clinical considerations that impact the relative effectiveness in therapeutics and in the alternative biomarkers’ ability to reveal the clinical benefits of these therapeutics.

Table of Contents

I.    EXECUTIVE SUMMARY

 

A.     Market Trends

1.      Biomarkers

2.      New Drug Targets

3.      Combination Therapies

B.     Moving Forward

 

II.    Competitive Overview

 

A.     Companies to Watch:

B.     Key Market Players

 

III.    Market Overview

 

A.     Cardiovascular Disease Prevalence

B.     Economic Considerations

C.     Atherosclerosis

D.     The Impact of Statins

E.      Current Market for Atherosclerosis Therapies

 

IV.    Future Market Implications

 

A.     Market Growth

B.     Pipeline Advances

C.     Biomarker Development

D.     Healthcare Costs and Reimbursement

 

V.    Market Opportunities:  Conclusions

 

VI.    Preamble: Raison d’Etre

 

VII.    Atherosclerotic Plaque Formation

 

VIII.    Biomarkers and Surrogate Endpoints

 

A.     Dynamic Range

B.     Responsiveness to Disease and Therapy

C.     Measurement Precision

D.     Convenience/Cost

 

IX.    Competitive Cardiovascular Biomarkers

 

A.     Lipoprotein-Associated Phospholipase A2 (Lp-PLA2)

B.     C-Reactive Protein (CRP)

C.     Inflammatory Cytokines

1.      Fibrinogen

2.      Lipoprotein A

3.      Cell Adhesion Molecules

4.      Homocysteine

5.      Adiponectin

6.      5-Lipoxygenase

D.     Markers of Renal Failure (Hematocrit, Creatinine, Microalbuminuria)

E.      Risk Analysis

 

X.    Emerging Diagnostic Imaging Techniques

 

XI.    Clinical Disease Management and Treatment Strategies

 

A.     Therapeutic Challenges

B.     Oxidative Stress

C.     Atherosclerosis

D.     Metabolic Syndrome

 

XII.    Marketed and Developmental Cardiovascular Therapeutics

 

A.     LDL Directed Therapeutics

1.      Statins

a)      Overall Effect of Statin Class of Therapeutics

b)      Safety Considerations

c)      Review of Key Statin-Related Trial Data

2.      HMG-CoA Reductase Reduction

B.     HDL Directed Therapeutics

1.      Apolipoprotein Therapeutics

2.      Apo A -I Milano

a)      Apo A-I Gene Therapy

b)      Apo A-I Mimetic Peptides

c)      Acyl-Coenzyme A Cholesterol Acyltransferase Inhibitors

d)      ABCA1 Transporter Manipulation

e)      D4F

f)        L-4F

g)      Microsomal Triglyceride Transfer Protein (MTP) Inhibitors

3.      CETP Inhibitors

a)      Torcetrapib

b)      CETi-1 Vaccine

c)      JTT-705

4.      High-Affinity LXR, FXR, and RXR Agonists

a)      LXRs

b)      FXRs

c)      RXRs

5.      Lecithin Cholesterol Acyltransferase Upregulators

6.      Scavenger Receptor Upregulators

7.      Niacin

C.     Impaired Cholesterol Absorption

1.      Zetia

2.      Fibrates

3.      Bile Acid Sequestrants

4.      Plant Sterols

D.     PPARs

E.      Renin-Angiotensin System

F.      Nitrous Oxide System (NOS)

G.     Novel Anti-Inflammatory Therapeutics

1.      AGI-1067

2.      Acomplia (rimonabant)

3.      Antrin (motexafin lutetium)

4.      Antioxidant Lp-PLA2 Antagonists

5.      5-Lipoxygenase Inhibitors

6.      Green/Black Tea

H.     Combination Products

1.      Vytorin

2.      Torcetrapib

3.      Advicor

4.      Caduet

 

XIII.    Supportive Anti-Inflammatory Trial Data

 

A.     The WOSCOPS Trial

B.     The ARIC Study

 

XIV.    Market Analysis: Atherosclerosis as an Unmet Medical Need

 

XV.    Regulatory Consideration

 

XVI.    Reimbursement and Healthcare

 

XVII.    Company Profiles

 

  1. Abbott Laboratories (ABT)

  2. Alteon (ALT)

  3. AstraZeneca (AZN)

  4. AtheroGenics (AGIX)

  5. AVANT Immunotherapeutics (AVAN)

  6. Bristol-Myers Squibb (BMY)

  7. Chugai Pharmaceutical (CHGCF.PK)

  8. deCode Genetics (DCGN)

  9. diaDexus (Private)

  10. Eli Lilly (LLY)

  11. Entelos (Private)

  12. Forbes Medi-Tech (FMTI)

  13. GlaxoSmithKline (GSK)

  14. Japan Tobacco

  15. Kos Pharmaceuticals (KOSP)

  16. Ligand Pharmaceuticals (LGND see Eli Lilly above.

  17. Lipid Sciences (LIPD)

  18. MaxoCore Pharmaceuticals (Private)

  19. Merck (MRK)

  20. NitroMed (NTMO)

  21. Pharmacyclics (PCYC)

  22. Pfizer (PFE)

  23. Roche (ROHHY)

  24. Sankyo Pharma (SKOXF.PK)

  25. Sanofi-Aventis (SNY)

  26. Schering-Plough (SGP)

  27. X-Ceptor Therapeutics (Private)

 

XVIII.     Key Take Aways

 

A.     More than Guilding the Lilly

B.     Statins are the Best for Now

C.     Statin/LDL/Guidelines

D.     Atherogenesis is Complex

E.      Prevention and Reversal

F.      Inflammation is Key

G.     Other Novel Approaches

H.     Cardiovascular Biomarkers

I.        Non Invasive Monitoring Devices can Provide Useful Data

J.       Combination Drugs – Wave of the Near-Future

K.    Biomarkers Can’t Do Everything

 

XIX.    CONCLUSION

 

XX.    Abbreviations & Acronyms

 

 

List of Exhibits

 

Exhibit 1. Leaders of the Anti-atherosclerotis Market 2004 and 2011

Exhibit 2. CHD Risk Categories, Goals, and Treatment Recommendations

Exhibit 3. Risk Factors For Atherosclerotic Vascular Disease

Exhibit 4. Distinguishing Clinical & Lab Findings for the Metabolic Syndrome

Exhibit 5. Oral Anti-Cholesterol Drugs

Exhibit 6. Comparison of Effects on Cholesterol Levels

Exhibit 7. Drug Effects of Statins on HDL

Exhibit 8: Effects of Lipid Lowering Agents

Exhibit 9. Drugs under Development for Dyslipidemia

Exhibit 10. Drugs under Development for Atherosclerosis

Exhibit 11. Metabolic targets for increasing HDL or reverse cholesterol transport

Exhibit 12. Schematic Depicting Multiple Biological Actions of HDL as a Potential Basis for Antiatherothrombotic Actions

Exhibit 13. PPAR Subtypes

Exhibit 14. Developmental PPARs

Exhibit 15. Comparison between AtheroGenics’s AIX-1067 and Esperion’s ETC-216

Exhibit 16. Interim Data Set for Phase II, CART 2 AGIX-1067 Trial

Exhibit 17. Anti-Oxidants

 


 

Cardiovascular Disease:  A Review of Biomarkers, Surrogate Endpoints and Therapeutic Options

Report #C225, October 2004
 

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 Contact: Patrick Driscoll, (949) 859-3401.

Copyright © 2006 MedMarket Diligence, LLC. All rights reserved.
Revised: 02/16/11

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