PCSK9 and Other Novel Hypercholesterolemia Drugs

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    September 2014

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Example Insights

  1. With statins going off-patent, pharmaceutical companies are hunting for next blockbusters for hypercholesterolemia. The approval and launch of Kynamro (ISIS Pharmaceuticals / Genzyme) and Juxtapid (Aegerion Pharmaceuticals) in late 2012 / early 2013 has changed the treatment paradigm for homozygous familial hypercholesterolemia.
  2. The market for developing novel cholesterol lowering drugs has gained attention of a number of multinational pharmaceutical companies including Amgen, Sanofi, Pfizer, GSK, Eli Lilly, Roche, Johnson & Johnson and more. Overall, there are 27 companies developing 29 molecules in clinical trials.
  3. Evolocumab, being developed by Amgen, has been filed with the FDA and EMA for approval.  Four more drugs are being evaluated in Phase III clinical trials. Three of these five late stage drugs are PCSK9 inhibitors (monoclonal antibodies), all of which are being developed by large multinational pharmaceutical companies.
  4. All three late stage PCSK9 inhibitors are monoclonal antibodies. Other approaches being investigated by drug developers include the use of antisense / siRNA and synthetic molecules.
  5. 2015 is likely to witness parallel launch of two anti-PCSK9 mAbs. We expect Evolocumab and Alirocumab to be made commercially available during 2015, while Bococizumab is expected to be available by 2017.
  6. Anacetrapib, an oral CETP inhibitor from Merck, can give head to head competition to PCSK9 inhibitors in dyslipidemia / hypercholesterolemia market if the Phase III outcome trial REVEAL shows positive results.
  7. In the base scenario, we forecast the market to hit USD 10 billion + sales by 2020. The upside is likely to be higher as the same drugs also start getting evaluated for treatment in the non-US and non-EU5 regions.

Overview

Worldwide statistics indicate that there is a high cholesterol burden despite the presence of many cholesterol-lowering drugs in the market. Out of all the available options, statins have been ubiquitously prescribed over the last 25 years. Researchers have concluded that reduction of plasma LDL cholesterol (LDLC) is the cornerstone of assessing heart risk. Irrespective of baseline cholesterol concentration, each mmol/L LDLC reduction translates to cardiovascular risk reduction by one-fifth. Although statins are well tolerated and reduce LDLC levels to the targets specified by NCEP and NICE guidelines, there is a residual cardiovascular risk. Heart diseases are the leading cause of death in the US and most of them are due to high cholesterol.

Statins, though the mainstay therapy for lowering cholesterol, have been associated with some adverse events. These have deterred their use in a subset of population termed as ‘Statin Intolerant’. Furthermore, patients with some genetic conditions such as Familial Hypercholesterolemia do not respond to statin therapy. Due to the long historical use of statins and the launch of generics (providing price advantage), the novel drugs will initially target only specific subset of patients for whom statins are clearly not the best treatment option. This need in the market for drugs that work through a different mechanism of action is coupled with a huge opportunity presented by a target population of around 20 million in the US and the EU5 countries.

 

Scope of the Report

The ‘PCSK9 and Other Novel Hypercholesterolemia Drugs, 2014 - 2024' report provides an extensive study of the new class of prescription drugs being evaluated for the treatment of high cholesterol levels caused both by genetic and lifestyle factors.

During the period 2012-2013 three such drugs - Juxtapid, Kynamro, and Lipaglyn - received market authorization; several more novel molecules are in clinical trials. These new drugs have different mechanism of actions: inhibiting or activating genes / proteins in cholesterol metabolism. Examples include PCSK9 inhibitors, CETP inhibitors, MTTP inhibitors, ApoB inhibitors and PPAR agonists. In addition, researchers are also evaluating gene silencing approach.

The report offers an in-depth analysis of four of the five novel classes of drugs mentioned above (PCSK9 inhibitors, MTTP inhibitors, ApoB gene silencers and CETP inhibitors). One of the key objectives is to provide readers a detailed insight into the landscape of novel prescription drugs for treatment of hypercholesterolemia. This is done by:

  • Identifying drug candidates based on their mechanism of cholesterol-lowering actions
  • Reviewing key efficacy and safety parameters for drugs in late-stage clinical trials
  • Reviewing the technologies behind drug-development
  • Understanding drivers and constraints of each drug-class
  • Assessing the competitive landscape, recent market developments such as relevant investments and partnerships
  • Evaluating the development and sales potential for each of the key molecules under consideration

The possibility of a drug to become blockbuster depends on various factors. In addition to safety and efficacy, other factors include cost, mode of administration, side effects and their approval and availability in various geographies. For each of these new classes of drugs, we have highlighted the key drivers and limiting factors. We have also presented our own perspective on how the acceptance and evolution of these drugs is likely to advance in the coming years. The analysis is backed by an extensive review of the hypercholesterolemia / dyslipidemia landscape and familial hypercholesterolemia (HoFH and HeFH) markets.

The base year for the report is 2013. The report provides market forecasts for the following two time horizons: 2014 - 2019 (short-midterm) and 2019 - 2024 (long term), respectively. The figures mentioned in this report are in USD, unless otherwise specified.

Contents

Chapter 2  provides an executive summary of the insights captured in our research. The summary offers a high level view on the likely evolution of hypercholesterolemia market with PCSK9 and other novel classes of upcoming cholesterol-lowering drugs.

Chapter 3  provides a general introduction to hypercholesterolemia, the current therapeutic options, their limitations, and emergence of new drug-classes. We discuss in detail about the role of cholesterol and how its high level in blood can be a threat to the community.

Chapter 4  provides the pipeline of novel drugs under development for treatment of high cholesterol levels. We have analysed the pipeline by mechanism of action, phase of development, drug developers, and type of molecule. We have also discussed the competitive landscape for three major indication areas – dyslipidemia, HoFH and HeFH. 

Chapter 5  presents the profiles of two recently approved drugs, Juxtapid and Kynamro. In this chapter, we have discussed the mechanisms, pharmacokinetics, dosage, and cost, phase III clinical studies details, present development status, partnerships, drivers and constraints related to both Juxtapid and Kynamro. In addition, we have also reviewed Isis’ anti-sense technology.

Chapter 6  presents the profiles of monoclonal antibodies that work by inhibiting PCSK9. We have profiled three late-stage biological drugs covering information about their discovery, mechanism of action, technology, completed / ongoing clinical trials, drivers and constraints.

Chapter 7  provides a detailed profile of Anacetrapib, a CETP inhibitor in phase III. In addition, we have discussed HDL as a cardiovascular marker, current HDL-raising interventions and other CETP inhibitors in development.

Chapter 8  provides analysis on the overall market outlook for the next ten years (2014 – 2024). We have followed a ‘bottom-up’ approach to estimate the likely sales potential of each of the molecules which are either marketed or are in advanced stages of clinical trials.

Chapter 9  summarizes the overall report. In this chapter, we provide a recap of the key takeaways and our independent opinion based on the research and analysis described in previous chapters.

Chapter 10  is an appendix, which provides tabulated data and numbers for all the figures provided.

Chapter 11  is an appendix, which provides the list of companies and organizations.

Table of Contents

1. PREFACE
1.1 Scope of the Report
1.2. Research Methodology
1.3. Chapter Outlines
 
2. EXECUTIVE SUMMARY
 
3. HYPERCHOLESTEROLEMIA: A MAJOR PROBLEM
3.1. Cholesterol: A Primer
3.2. Hypercholesterolemia
3.2.1. Familial Hypercholesterolemia
3.3. LDL Cholesterol (LDLC): An Important Target For High Cholesterol Management
3.4. Population Suffering From Hypercholesterolemia
3.5. Current Therapeutic Interventions and Their Limitations
3.5.1. Statins
3.5.2. Risks Associated With Statins
3.5.3. Lower Reduction of Mortality and High NNT
3.5.4. Other Marketed Drug Classes
3.6. New Emerging Therapies: PCSK9 and Others
3.7. Barriers to Success
3.7.1. New Cholesterol Management Guidelines
3.7.2. Route of Delivery and Price
 
4. CURRENT MARKET LANDSCAPE
4.1. Scope and Observations
4.2. Two Novel Drugs Approved for Homozygous Familial Hypercholesterolemia
4.3. Another First In Class Cholesterol Lowering Drug Approved in India
4.4. Market Attracting Both Large and Small Pharma Companies
4.5. Five Novel Drugs in Late Stage Development
4.6. Companies Evaluating Different Molecule Types: From Synthetics to Biologics
4.7. PCSK9 Inhibitors: The Most Sought After Drug Class Under Development
4.7.1. PCSK9 Inhibitors Pipeline Analysis
4.8. Competitive Analysis of Key Indication Areas For Cholesterol Lowering Drugs
4.8.1. Hypercholesterolemia/Dyslipidemia Market
4.8.2. HoFH Market
4.8.3. HeFH Market
 
5. NOVEL MARKETED DRUGS: MTTP INHIBITORS AND Apo B GENE SILENCER
5.1. Recently Approved Drugs for Familial Hypercholesterolemia
5.2. Juxtapid / Lojuxta (Lomitapide)
5.2.1. Overview
5.2.2. Structure and Mechanism of Action
5.2.3. Adverse Reactions and Warnings
5.2.4. Drug Interactions
5.2.5. Dosage, Cost and Manufacturing
5.2.6. History of Development
5.2.7. Orphan Drug Status
5.2.8. Patents
5.2.9. Phase III Results
5.2.10. Current State of Development
5.2.11. Partnerships
5.2.12. Historical Sales
 
5.3. Kynamro (Mipomersen)
5.3.1. Overview
5.3.2. Structure and Mechanism of Action
5.3.3. Patents
5.3.4. Antisense Technology
5.3.4.1. Overview
5.3.4.2. Patents Covering Technology
5.3.5. Pharmacokinetics
5.3.6. Adverse Reactions and Warnings
5.3.7. Dosage, Cost and Manufacturing
5.3.8. Phase III Results
5.3.9. Current State of Development
5.3.10. Partnerships
5.3.10.1. Genzyme
5.3.10.2. Gilead Sciences
5.3.10.3. Other Collaborations
5.3.11. Awards
5.3.11.1. Breakthrough Alliance Award
5.3.11.2. Partners in Progress Corporate Award
 
5.4. Mipomersen and Lomitapide: Roots Analysis’ Perspective
 
6. PCSK9 INHIBITORS: KEY MOLECULES AND FUTURE OUTLOOK
6.1. Discovery of PCSK9 Inhibitors
6.2. Mechanism of Action
 
6.3. Evolocumab (AMG 145)
6.3.1. Overview
6.3.2 Evolocumab has the First Mover Advantage
6.3.3. Current Phase of Development
6.3.4. Drug Delivery Systems Under Review
6.3.5. Partnerships
 
6.4. Alirocumab (REGN727 / SAR236553)
6.4.1. Overview
6.4.2. Providing Close Competition to Evolocumab with Expedited Review
6.4.3 VelocImmune Technology
6.4.3.1. Overview
7.4.3.2. Patent Portfolio
6.4.4. Current Phase of Development
6.4.5. Drug Delivery Systems Under Review
6.4.6. Partnerships
6.4.6.1. Sanofi Aventis
6.4.6.2. American College of Cardiology (ACC)
6.4.6.3. Academic VelocImmune Investigators’ Program
6.4.6.4. Astellas Pharmaceuticals
6.4.6.5. AstraZeneca
 
6.5 Bococizumab (RN-316/PF-04950615)
6.5.1. Overview
6.5.2. ENHANZE Technology
6.5.3. Current Phase of Development
6.5.4. Drug Delivery Systems under Review
6.5.5. Partnerships
 
6.6. PCSK9 Inhibitors: Roots Analysis’ Perspective
 
7. CETP INHIBITORS: KEY MOLECULES AND FUTURE OUTLOOK
7.1. HDL: The Target for CETP Inhibitors
7.2. HDL Formation and Reverse Cholesterol Transport
7.3. Current Therapies Raising HDLC and the Need to Develop New Ones
7.4. Mechanism of CETP Inhibition
7.5. CETP Inhibitors in Phase III Development
 
7.6. Anacetrapib
7.6.1. Overview
7.6.2. Structure
7.6.3. Patent Portfolio
7.6.4. Pharmacokinetics
7.6.5 Current Development Status
 
7.7. CETP Inhibitors: Roots Analysis’ Perspective
 
8. OVERALL MARKET OUTLOOK
8.1. Chapter Overview
8.2. Scope and Methodology
8.3. Overall Market Forecast
8.4. Juxtapid
8.4.1. Sales Forecast, Short-Mid Term (2014 - 2019)
8.4.2. Sales Forecast, Long Term (2019 – 2024)
8.5. Kynamro
8.5.1. Sales Forecast, Short-Mid Term (2014 - 2019)
8.5.2. Sales Forecast, Long Term (2019 - 2024)
8.6. Evolocumab
8.6.1. Sales Forecast, Short-Mid Term (2014 - 2019)
8.6.2. Sales Forecast: Long Term (2019 - 2024)
8.7. Alirocumab
8.7.1. Sales Forecast, Short-Mid Term (2014 - 2019)
8.7.2. Sales Forecast, Long Term (2019 - 2024)
8.8. Bococizumab
8.8.1. Sales Forecast, Short-Mid Term (2014 - 2019)
8.8.2. Sales Forecast, Long Term (2019 - 2024)
8.9. Anacetrapib
8.9.1. Sales Forecast, Short-Mid Term (2014 - 2019)
8.9.2. Sales Forecast, Long Term (2019 - 2024)
 
9. CONCLUSION
9.1. A Valuable Weapon Against Cardiovascular Diseases
9.2. Statin Refractory and/or Familial Hypercholesterolemia Patients Will be the Key Drivers
9.3. Kynamro and Juxtapid Will Dominate the HoFH Market in Short Term
9.4. Future Growth Hinged Upon Results of Long-term Clinical Safety and Cardiovascular Outcome Studies
9.5 Concluding Remarks
 
10. APPENDIX 1: TABULATED DATA
 
11. APPENDIX 2: LIST OF COMPANIES

List of Figures

Figure 3.1 Low Density Lipoprotein (LDL) and High Density Lipoprotein (HDL): Comparison
Figure 3.2 Forms of Cardiovascular Diseases
Figure 3.3 Statins: Mechanism of Action
Figure 4.1 Pipeline Analysis: Distribution by Drug Development
Figure 4.2 Pipeline Analysis: Distribution by Phase of Development
Figure 4.3 Pipeline Analysis: Distribution by Type of Molecule
Figure 4.4 Pipeline Analysis: Distribution by Drug Class
Figure 4.5 PCSK9 Pipeline Analysis: Distribution by Phase of Development
Figure 4.6 PCSK9 Pipeline Analysis: Distribution by Type of Drug
Figure 5.1 Structure of Lomitapide
Figure 5.2 MTTP Inhibitor and apoB Gene Silencer: Drivers and Restraints
Figure 6.1 PCSK9 Inhibitors: Drivers and Restraints
Figure 7.1 Anacetrapib: Chemical Structure
Figure 7.2 CETP Inhibitors: Drivers and Restraints
Figure 8.1  Overall PCSK9 and Other Novel Cholesterol Lowering Drugs Market Forecast: Base Scenario (USD Million)
Figure 8.2  Juxtapid Sales Forecast: Short-Mid Term, Base Scenario (2014-2019, USD Million)
Figure 8.3  Juxtapid Sales Forecast: Long Term, Base Scenario (2019-2024, USD Million)
Figure 8.4  Kynamro Sales Forecast: Short-Mid Term, Base Scenario (2014-2019, USD Million)
Figure 8.5  Kynamro Sales Forecast: Long Term, Base Scenario (2019-2024, USD Million)
Figure 8.6  Evolocumab Sales Forecast: Short-Mid Term, Base Scenario (2014-2019, USD Million)
Figure 8.7  Evolocumab Sales Forecast: Long Term, Base Scenario (2019-2024, USD Million)
Figure 8.8 Alirocumab Sales Forecast: Short-Mid Term, Base Scenario (2014-2019, USD Million)
Figure 8.9 Alirocumab Sales Forecast: Long Term, Base Scenario (2019-2024, USD Million)
Figure 8.10  Bococizumab Sales Forecast: Short-Mid Term, Base Scenario (2014-2019, USD Million)
Figure 8.11  Bococizumab Sales Forecast: Long Term, Base Scenario (2019-2024, USD Million)
Figure 8.12  Anacetrapib Sales Forecast: Short-Mid Term, Base Scenario (2014-2019, USD Million)
Figure 8.13  Anacetrapib Sales Forecast: Long Term, Base Scenario (2019-2024, USD Million)

List of Tables

Table 3.1 Cholesterol Levels in HeFH and HoFH
Table 3.2 Statins: Efficacy, Sales, and Patent Expiry
Table 3.3 Details of Cholesterol Lowering Drugs Other Than Statins
Table 4.1 Pipeline of Novel Cholesterol Lowering Drugs, 2014
Table 4.2 Marketed and Phase III Drugs: List by Type of Molecule
Table 4.3 PCSK9 Inhibitors in Early Stage Development, 2014
Table 4.4 Comparison of Drugs in Market and Pipeline for Hypercholesterolemia, 2014
Table 4.5 Comparison of Treatment Options Available for HoFH, 2014
Table 4.6 Key Phase III Parameters and Results for Kynamro, Juxtapid and Evolocumab
Table 4.7 Comparison of Treatment Options Available for HeFH, 2014
Table 4.8 Comparison of Drugs under Development for HeFH, 2014 
Table 5.1 Lomitapide: Pharmacokinetic Properties
Table 5.2 Lomitapide: Dosage and Capsule Details
Table 5.3 Lomitapide: Approval Timeline
Table 5.4 Lomitapide: Patent Portfolio
Table 5.5  Lomitapide: Phase III Study for HoFH
Table 5.6  Lomitapide: Ongoing Phase III Clinical Trials
Table 5.7  Lomitapide: Historical Sales (USD Million)
Table 5.8  Mipomersen: Patent Portfolio
Table 5.9 Drugs based on Antisense Technology
Table 5.10 ISIS Antisense Technology: Patent Portfolio
Table 5.11 Mipomersen: Pharmacokinetic Properties
Table 5.12 Mipomersen: Completed Phase III Studies
Table 5.13 Mipomersen: Ongoing Clinical Trials
Table 5.14 Antisense Technology: Partnerships
Table 6.1 Evolocumab: Completed Phase III Studies
Table 6.2 Evolocumab: Ongoing Clinical Trials
Table 6.3 VelocImmune Technology: Antibodies in Pipeline
Table 6.4 VelocImmune Technology: Patent Portfolio
Table 6.5 Alirocumab: Phase I and Phase II Completed Studies
Table 6.6 Alirocumab: Completed Phase III Studies
Table 6.7 Alirocumab: Ongoing ODYSSEY Trials
Table 6.8 Alirocumab: Interim Results from Phase III Trials
Table 6.9 Alirocumab: Other Active Studies
Table 6.10 Companies Using ENHANZE Technology
Table 6.11 ENHANZE: Patent Portfolio
Table 6.12 Bococizumab: Phase I and Phase II Completed Studies
Table 6.13 Bococizumab: Phase II Details of NCT01592240
Table 6.14 Bococizumab: Active Phase III Studies
Table 7.1 Drugs Targeting Increase in HDLC
Table 7.2 Phase III CETP Inhibitors: Development Status
Table 7.3 Anacetrapib: Patent Portfolio
Table 7.4 Pharmacokinetic Properties of Anacetrapib
Table 7.5 Anacetrapib: Active Phase III Clinical Trials
Table 9.1 Long Term Safety / Efficacy and Outcome Studies
Table 10.1 Pipeline Analysis: Distribution by Phase of Development
Table 10.2 Pipeline Analysis: Distribution by Type of Molecule
Table 10.3 Pipeline Analysis: Distribution by Drug Class
Table 10.4 PCSK9 Pipeline Analysis: Distribution by Phase of Development
Table 10.5 PCSK9 Pipeline Analysis: Distribution by Type of Drug
Table 10.6 Overall PCSK9 and Other Novel Cholesterol Lowering Drugs Market Forecast: Base Scenario (USD Million)
Table 10.7 Overall PCSK9 and Other Novel Cholesterol Lowering Drugs Market Forecast: Conservative Scenario (USD Million)
Table 10.8 Overall PCSK9 and Other Novel Cholesterol Lowering Drugs Market Forecast: Optimistic Scenario (USD Million)
Table 10.9 Juxtapid Sales Forecast: Short-Mid Term, Base Scenario (2014-2019, USD Million)
Table 10.10 Juxtapid Sales Forecast: Short-Mid Term, Conservative Scenario (2014-2019, USD Million)
Table 10.11 Juxtapid Sales Forecast: Short-Mid Term, Optimistic Scenario (2014-2019, USD Million)
Table 10.12 Juxtapid Sales Forecast: Long Term, Base Scenario (2019-2024, USD Million)
Table 10.13 Juxtapid Sales Forecast: Long Term, Conservative Scenario (2019-2024, USD Million)
Table 10.14 Juxtapid Sales Forecast: Long Term, Optimistic Scenario (2019-2024, USD Million)
Table 10.15 Kynamro Sales Forecast: Short-Mid Term, Base Scenario (2014-2019, USD Million)
Table 10.16  Kynamro Sales Forecast: Short-Mid Term, Conservative Scenario (2014-2019, USD Million)
Table 10.17 Kynamro Sales Forecast: Short-Mid Term, Optimistic Scenario (2014-2019, USD Million)
Table 10.18 Kynamro Sales Forecast: Long Term, Base Scenario (2019-2024, USD Million)
Table 10.19 Kynamro Sales Forecast: Long Term, Conservative Scenario (2019-2024, USD Million)
Table 10.20 Kynamro Sales Forecast: Long Term, Optimistic Scenario (2019-2024, USD Million)
Table 10.21 Evolocumab Sales Forecast: Short-Mid Term, Base Scenario (2014-2019, USD Million)
Table 10.22  Evolocumab Sales Forecast: Short-Mid Term, Conservative Scenario (2014-2019, USD Million)
Table 10.23 Evolocumab Sales Forecast: Short-Mid Term, Optimistic Scenario (2014-2019, USD Million)
Table 10.24 Evolocumab Sales Forecast: Long Term, Base Scenario (2019-2024, USD Million)
Table 10.25 Evolocumab Sales Forecast: Long Term, Conservative Scenario (2019-2024, USD Million)
Table 10.26 Evolocumab Sales Forecast: Long Term, Optimistic Scenario (2019-2024, USD Million)
Table 10.27 Alirocumab Sales Forecast: Short-Mid Term, Base Scenario (2014-2019, USD Million)
Table 10.28 Alirocumab Sales Forecast: Short-Mid Term, Conservative Scenario (2014-2019, USD Million)
Table 10.29 Alirocumab Sales Forecast: Short-Mid Term, Optimistic Scenario (2014-2019, USD Million)
Table 10.30 Alirocumab Sales Forecast: Long Term, Base Scenario (2019-2024, USD Million)
Table 10.31 Alirocumab Sales Forecast: Long Term, Conservative Scenario (2019-2024, USD Million)
Table 10.32 Alirocumab Sales Forecast: Long Term, Optimistic Scenario (2019-2024, USD Million)
Table 10.33 Bococizumab Sales Forecast: Short-Mid Term, Base Scenario (2014-2019, USD Million)
Table 10.34 Bococizumab Sales Forecast: Short-Mid Term, Conservative Scenario (2014-2019, USD Million)
Table 10.35 Bococizumab Sales Forecast: Short-Mid Term, Optimistic Scenario (2014-2019, USD Million)
Table 10.36 Bococizumab Sales Forecast: Long Term, Base Scenario (2019-2024, USD Million)
Table 10.37 Bococizumab Sales Forecast: Long Term, Conservative Scenario (2019-2024, USD Million)
Table 10.38 Bococizumab Sales Forecast: Long Term, Optimistic Scenario (2019-2024, USD Million)
Table 10.39 Anacetrapib Sales Forecast: Short-Mid Term, Base Scenario (2014-2019, USD Million)
Table 10.40 Anacetrapib Sales Forecast: Short-Mid Term, Conservative Scenario (2014-2019, USD Million)
Table 10.41 Anacetrapib Sales Forecast: Short-Mid Term, Optimistic Scenario (2014-2019, USD Million)
Table 10.42 Anacetrapib Sales Forecast: Long Term, Base Scenario (2019-2024, USD Million)
Table 10.43 Anacetrapib Sales Forecast: Long Term, Conservative Scenario (2019-2024, USD Million)
Table 10.44 Anacetrapib Sales Forecast: Long Term, Optimistic Scenario (2019-2024, USD Million)

Listed Companies

The following companies and organisations have been mentioned in this report.

  1. Aegerion Pharmaceuticals
  2. Alnylam Pharmaceuticals
  3. American College of Cardiology
  4. American Heart Association
  5. Amgen
  6. Astellas Pharma
  7. AstraZeneca
  8. AtheroNova Inc.
  9. Baxter International
  10. Biogen Idec
  11. Bristol Myers Squibb
  12. British Heart Foundation
  13. Catabasis Pharmaceuticals
  14. Catalent Pharma Solutions
  15. Cerenis Therapeutics
  16. Cymabay Therapeutics
  17. Daiichi Sankyo
  18. Deloitte
  19. Dozima Pharma
  20. Eli Lilly
  21. EMA
  22. Esperion Therapeutics
  23. Excaliard Pharmaceuticals
  24. FDA
  25. Genzyme
  26. Gilead Sciences
  27. GlaxoSmithKline
  28. Halozyme Therapeutics
  29. Hospira
  30. Idera Pharmaceuticals
  31. Intrexon
  32. ISIS Pharmaceuticals
  33. Johnson & Johnson
  34. Kowa 
  35. LipimetiX
  36. Lupin Pharmaceuticals
  37. Madrigal Pharmaceuticals
  38. Merck
  39. Meridian Medical Technologies
  40. Mitsubishi Tanabe
  41. NHLBI (National Heart, Lung, and Blood Institute)
  42. Novartis
  43. Pfizer
  44. Regeneron
  45. Resverlogix
  46. Roche 
  47. Sandoz Pharmaceuticals
  48. Sanofi
  49. Santaris Pharma
  50. Serometrix
  51. Shifa Biomedical
  52. Upsher Smith Laboratories
  53. Viropharma
  54. Xenon Pharmaceuticals
  55. Zhejiang Hisun Chemical
  56. Zydus Cadilla

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