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  4. > Product and Pipeline Analysis of the Global Therapeutic Lipid Modulators Market

Relentless Pursuit of Blockbuster Cardiovascular Therapeutics

Dyslipidemia exists in many forms and is prevalent in developed regions. Although many patients with moderately elevated lipids are well served by available therapies, there is a significant patient population for whom these therapies are inappropriate or inadequate, thereby prompting development of innovative therapies to fill the gaps. This research service includes comprehensive information on the market background, analyses of drug development, detailed product and pipeline analyses, detailed product profiles for key marketed/late-stage products, and a global overview. The research service also provides time-sensitive details such as new product launch timelines, PCSK9 Phase 3 programs, and patent expirations.

Executive Summary

-Most therapeutic lipid modulators in development are targeting the unmet needs of patients with high lipid levels beyond the reach of available drugs.
-The market is experiencing a tight race between 3 members of a promising new drug class: Inhibitors of proprotein convertase subtilisin-kexin type 9 (PCSK9).
oAmong the close competitors in the PCSK9 race, Amgen is currently the front runner, with an expected filing for regulatory approval of evolocumab planned in 2014. Sanofi and Regeneron are approximately to months behind, with regulatory filing of alirocumab planned for 2015. Pfizer is potentially filing bococizumab in 2016.
oAll 3 PCSK9 Phase 3 programs include a cardiovascular outcomes trial (CVOT) of approximately to patients.
oAmgen’s Phase 3 program for evolocumab is the largest of the competitors, including over patients across clinical trials, one of which is evaluating the drug’s effect on atherosclerotic plaque through an intravascular ultrasound.
oThe Sanofi/Regeneron Phase 3 program for alirocumab is nearly as extensive, with over patients enrolled across trials.
oPfizer’s Phase 3 program for bococizumab includes over patients enrolled across trials, with of those trials evaluating the effect of bococizumab on cardiovascular outcomes.
-Other targets of drugs in development include cholesteryl ester transfer protein (CETP), liver X receptor (LXR), peroxisome proliferator-activated receptor delta (PPAR?), and diglyceride acyltransferase (DGAT), among several additional novel targets.
-New clinical guidelines for cholesterol management released by the American Heart Association (AHA) and the American College of Cardiology (ACC) focus on treating with statins according to a cardiovascular risk profile, as opposed to treating to a specified low-density lipoprotein cholesterol (LDL-C) target. While these new recommendations have the potential to widen significantly the statin-appropriate population, clinicians may be slow to change practice.
oSimilar recommendations were recently announced in the United Kingdom.
-Among the recently approved and late-stage lipid-lowering drugs such as mipomersen, lomitipide, and PCSK9 inhibitors, none will replace statin therapy for the general hyperlipidemic population in the foreseeable future. However, these drugs may be useful as adjunctive therapies, as statin alternatives for statin-intolerant patients, or for special populations for which statins are inadequate.

Methodology and Scope

-This research service focuses on prescription drugs to manage primary and secondary forms of dyslipidemia, including hypercholesterolemia, hypertriglyceridemia, and mixed dyslipidemia. This service does not include prescription medical foods or over-the-counter supplements.
-A product and pipeline assessment is provided for marketed and investigational drugs for the management of dyslipidemia. Segmentation by drug class is provided along with additional supporting information such as clinical trial timelines and results, projected launch timelines, and epidemiology.
-The information contained in this research service was derived from published sources, including the following: disease organization Web sites; public health organization Web sites; company publications such as annual reports, SEC filings, and press releases; government public sources; and published articles in scientific journals.

Table Of Contents

Product and Pipeline Analysis of the Global Therapeutic Lipid Modulators Market
1. EXECUTIVE SUMMARY

Recent Market Developments
Defining Healthcare Trends in the Future
Companies to Watch

2. METHODOLOGY AND SCOPE

Methodology and Scope

3. INTRODUCTION

Introduction

4. MARKET BACKGROUND

Lipid and Lipoprotein Basics
Prevalence of Elevated Cholesterol in Major Markets
Prevalence and Management of Elevated LDL-C in the United States
Classification of Lipoprotein Levels
Classification of Familial Dyslipidemias
ACC/AHA Practice Guidelines
European Practice Guidelines
Market Segmentation

5. COMPETITIVE LANDSCAPE

Competitive Landscape—Number of Marketed and Pipeline Products
Competitive Landscape—Marketed and Pipeline Products
Marketed Product Analysis
Pipeline Analysis
Product Launch Timeline
Patent Expiration Timeline
Phase 3 Clinical Program—Evolocumab (Amgen)
Phase 3 Data Readouts—Evolocumab (Amgen)
Phase 3 Clinical Program—Alirocumab (Sanofi/Regeneron)
Phase 3 Clinical Program—Bococizumab (Pfizer)
Comparative Efficacy Analysis
Comparative Efficacy Analysis Discussion

6. PROFILES OF RECENTLY LAUNCHED AND LATE-STAGE INVESTIGATIONAL PRODUCTS

Product Dashboard—Kynamro (mipomersen sodium)
Product Dashboard—Juxtapid/Lojuxta (lomitapide)
Product Dashboard—Vascepa (icosapent ethyl)
Product Dashboard—Evolocumab (AMG145)
Product Dashboard—Alirocumab (REGN727)
Product Dashboard—Bococizumab (RN316)

7. CONCLUSIONS AND RECOMMENDATIONS

Legal Disclaimer

8. THE FROST and SULLIVAN STORY

Value Proposition
Global Perspective
Industry Convergence
360º Research Perspective
Implementation Excellence
Our Blue Ocean Strategy

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