Familial Hypercholesterolemia (Type II Hyperlipoproteinemia)-Pipeline Review, H2 2015

Familial Hypercholesterolemia (Type II Hyperlipoproteinemia)-Pipeline Review, H2 2015


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Executive Summary

Familial Hypercholesterolemia (Type II Hyperlipoproteinemia)-Pipeline Review, H2 2015

Summary

Global Markets Direct's, 'Familial Hypercholesterolemia (Type II Hyperlipoproteinemia)-Pipeline Review, H2 2015', provides an overview of the Familial Hypercholesterolemia (Type II Hyperlipoproteinemia)'s therapeutic pipeline.

This report provides comprehensive information on the therapeutic development for Familial Hypercholesterolemia (Type II Hyperlipoproteinemia), complete with comparative analysis at various stages, therapeutics assessment by drug target, mechanism of action (MoA), route of administration (RoA) and molecule type, along with latest updates, and featured news and press releases. It also reviews key players involved in the therapeutic development for Familial Hypercholesterolemia (Type II Hyperlipoproteinemia) and special features on late-stage and discontinued projects.

Global Markets Direct's report features investigational drugs from across globe covering over 20 therapy areas and nearly 3,000 indications. The report is built using data and information sourced from Global Markets Direct's proprietary databases, Company/University websites, SEC filings, investor presentations and featured press releases from company/university sites and industry-specific third party sources, put together by Global Markets Direct's team. Drug profiles/records featured in the report undergoes periodic updation following a stringent set of processes that ensures that all the profiles are updated with the latest set of information. Additionally, processes including live news & deals tracking, browser based alert-box and clinical trials registries tracking ensure that the most recent developments are captured on a real time basis.

The report enhances decision making capabilities and help to create effective counter strategies to gain competitive advantage. It strengthens R&D pipelines by identifying new targets and MOAs to produce first-in-class and best-in-class products.

Note*: Certain sections in the report may be removed or altered based on the availability and relevance of data for the indicated disease.

Scope

The report provides a snapshot of the global therapeutic landscape of Familial Hypercholesterolemia (Type II Hyperlipoproteinemia)

The report reviews key pipeline products under drug profile section which includes, product description, MoA and R&D brief, licensing and collaboration details & other developmental activities

The report reviews key players involved in the therapeutics development for Familial Hypercholesterolemia (Type II Hyperlipoproteinemia) and enlists all their major and minor projects

The report summarizes all the dormant and discontinued pipeline projects

A review of the Familial Hypercholesterolemia (Type II Hyperlipoproteinemia) products under development by companies and universities/research institutes based on information derived from company and industry-specific sources

Pipeline products coverage based on various stages of development ranging from pre-registration till discovery and undisclosed stages

A detailed assessment of monotherapy and combination therapy pipeline projects

Coverage of the Familial Hypercholesterolemia (Type II Hyperlipoproteinemia) pipeline on the basis of target, MoA, route of administration and molecule type

Latest news and deals relating related to pipeline products

Reasons To Buy

Provides strategically significant competitor information, analysis, and insights to formulate effective R&D development strategies

Identify emerging players with potentially strong product portfolio and create effective counter-strategies to gain competitive advantage

Develop strategic initiatives by understanding the focus areas of leading companies

Identify and understand important and diverse types of therapeutics under development for Familial Hypercholesterolemia (Type II Hyperlipoproteinemia)

Plan mergers and acquisitions effectively by identifying key players of the most promising pipeline

Devise corrective measures for pipeline projects by understanding Familial Hypercholesterolemia (Type II Hyperlipoproteinemia) pipeline depth and focus of Indication therapeutics

Develop and design in-licensing and out-licensing strategies by identifying prospective partners with the most attractive projects to enhance and expand business potential and scope

Modify the therapeutic portfolio by identifying discontinued projects and understanding the factors that drove them from pipeline



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Table of Contents

Table of Contents 2

List of Tables 6

List of Figures 7

Introduction 8

Global Markets Direct Report Coverage 8

Familial Hypercholesterolemia (Type II Hyperlipoproteinemia) Overview 9

Therapeutics Development 10

Pipeline Products for Familial Hypercholesterolemia (Type II Hyperlipoproteinemia)-Overview 10

Pipeline Products for Familial Hypercholesterolemia (Type II Hyperlipoproteinemia)-Comparative Analysis 11

Familial Hypercholesterolemia (Type II Hyperlipoproteinemia)-Therapeutics under Development by Companies 12

Familial Hypercholesterolemia (Type II Hyperlipoproteinemia)-Therapeutics under Investigation by Universities/Institutes 14

Familial Hypercholesterolemia (Type II Hyperlipoproteinemia)-Pipeline Products Glance 15

Late Stage Products 15

Clinical Stage Products 16

Early Stage Products 17

Unknown Stage Products 18

Familial Hypercholesterolemia (Type II Hyperlipoproteinemia)-Products under Development by Companies 19

Familial Hypercholesterolemia (Type II Hyperlipoproteinemia)-Products under Investigation by Universities/Institutes 21

Familial Hypercholesterolemia (Type II Hyperlipoproteinemia)-Companies Involved in Therapeutics Development 22

Aegerion Pharmaceuticals, Inc. 22

Cerenis Therapeutics Holding SA 23

CymaBay Therapeutics, Inc. 24

Gemphire Therapeutics Inc. 25

Merck & Co., Inc. 26

Pfizer Inc. 27

Regeneron Pharmaceuticals, Inc. 28

RegenxBio Inc. 29

Sanofi 30

Thetis Pharmaceuticals LLC 31

Familial Hypercholesterolemia (Type II Hyperlipoproteinemia)-Therapeutics Assessment 32

Assessment by Monotherapy Products 32

Assessment by Combination Products 33

Assessment by Target 34

Assessment by Mechanism of Action 36

Assessment by Route of Administration 38

Assessment by Molecule Type 40

Drug Profiles 42

(ezetimibe + atorvastatin calcium)-Drug Profile 42

Product Description 42

Mechanism of Action 42

R&D Progress 42

AEM-28-Drug Profile 43

Product Description 43

Mechanism of Action 43

R&D Progress 43

AEM-28-02-Drug Profile 44

Product Description 44

Mechanism of Action 44

R&D Progress 44

AEM-2814-Drug Profile 45

Product Description 45

Mechanism of Action 45

R&D Progress 45

alirocumab-Drug Profile 46

Product Description 46

Mechanism of Action 46

R&D Progress 46

AM-0010-Drug Profile 50

Product Description 50

Mechanism of Action 50

R&D Progress 50

anacetrapib-Drug Profile 51

Product Description 51

Mechanism of Action 51

R&D Progress 51

Antisense Oligonucleotides to Inhibit ApoB100 for Familial Hypercholesterolemia-Drug Profile 53

Product Description 53

Mechanism of Action 53

R&D Progress 53

bococizumab-Drug Profile 54

Product Description 54

Mechanism of Action 54

R&D Progress 54

BSN-272-Drug Profile 55

Product Description 55

Mechanism of Action 55

R&D Progress 55

CER-001-Drug Profile 56

Product Description 56

Mechanism of Action 56

R&D Progress 56

evinacumab-Drug Profile 58

Product Description 58

Mechanism of Action 58

R&D Progress 58

gemcabene calcium-Drug Profile 59

Product Description 59

Mechanism of Action 59

R&D Progress 59

lomitapide mesylate-Drug Profile 60

Product Description 60

Mechanism of Action 60

R&D Progress 60

MBX-8025-Drug Profile 63

Product Description 63

Mechanism of Action 63

R&D Progress 63

mipomersen sodium-Drug Profile 65

Product Description 65

Mechanism of Action 65

R&D Progress 65

RGX-501-Drug Profile 67

Product Description 67

Mechanism of Action 67

R&D Progress 67

TP-452-Drug Profile 68

Product Description 68

Mechanism of Action 68

R&D Progress 68

Familial Hypercholesterolemia (Type II Hyperlipoproteinemia)-Recent Pipeline Updates 69

Familial Hypercholesterolemia (Type II Hyperlipoproteinemia)-Dormant Projects 90

Familial Hypercholesterolemia (Type II Hyperlipoproteinemia)-Discontinued Products 91

Familial Hypercholesterolemia (Type II Hyperlipoproteinemia)-Product Development Milestones 92

Featured News & Press Releases 92

Sep 01, 2015: Sanofi And Regeneron Announce New Positive Praluent Phase 3 Data Presented At Esc Congress 2015 92

Aug 03, 2015: Isis Reports Positive Data from KYNAMRO (mipomersen sodium) FOCUS FH Phase 3 Study in Patients with Severe Heterozygous Familial Hypercholesterolemia 93

Jul 24, 2015: Sanofi And Regeneron Announce FDA Approval Of Praluent (Alirocumab) Injection, The First Pcsk9 Inhibitor In The U.S., For The Treatment Of High LDL Cholesterol In Adult Patients 94

May 26, 2015: Aegerion Pharmaceuticals Achieves Primary Endpoint in Phase III Study of Lomitapide in Japanese Patients With Homozygous Familial Hypercholesterolemia (HoFH) 96

Apr 30, 2015: AOP Orphan Launches Lojuxta (lomitapide) for Treatment of Homozygous Familial Hypercholesterolaemia to the Austrian Market 96

Apr 23, 2015: CymaBay Therapeutics Announces the Initiation of a Phase 2 Study of MBX-8025 in Patients With Homozygous Familial Hypercholesterolemia 98

Mar 25, 2015: CymaBay Therapeutics Announces U.S. Orphan Drug Designation for MBX-8025 in Homozygous Familial Hypercholesterolemia 99

Jan 28, 2015: Aegerion Investigated by Former Louisiana Attorney General and Special Prosecutor Richard P. Ieyoub and the Firm of Ieyoub O'Bell & Myers 99

Nov 18, 2014: Genzyme And Isis Present KYNAMRO Clinical Data At The American Heart Association 100

Sep 02, 2014: Isis Pharmaceuticals Presents Data On KYNAMRO At European Society of Cardiology Congress 2014 101

Appendix 103

Methodology 103

Coverage 103

Secondary Research 103

Primary Research 103

Expert Panel Validation 103

Contact Us 103

Disclaimer 104

List of Tables

Number of Products under Development for Familial Hypercholesterolemia (Type II Hyperlipoproteinemia), H2 2015 10

Number of Products under Development for Familial Hypercholesterolemia (Type II Hyperlipoproteinemia)-Comparative Analysis, H2 2015 11

Number of Products under Development by Companies, H2 2015 13

Number of Products under Investigation by Universities/Institutes, H2 2015 14

Comparative Analysis by Late Stage Development, H2 2015 15

Comparative Analysis by Clinical Stage Development, H2 2015 16

Comparative Analysis by Early Stage Development, H2 2015 17

Comparative Analysis by Unknown Stage Development, H2 2015 18

Products under Development by Companies, H2 2015 19

Products under Development by Companies, H2 2015 (Contd...1) 20

Products under Investigation by Universities/Institutes, H2 2015 21

Familial Hypercholesterolemia (Type II Hyperlipoproteinemia)-Pipeline by Aegerion Pharmaceuticals, Inc., H2 2015 22

Familial Hypercholesterolemia (Type II Hyperlipoproteinemia)-Pipeline by Cerenis Therapeutics Holding SA, H2 2015 23

Familial Hypercholesterolemia (Type II Hyperlipoproteinemia)-Pipeline by CymaBay Therapeutics, Inc., H2 2015 24

Familial Hypercholesterolemia (Type II Hyperlipoproteinemia)-Pipeline by Gemphire Therapeutics Inc., H2 2015 25

Familial Hypercholesterolemia (Type II Hyperlipoproteinemia)-Pipeline by Merck & Co., Inc., H2 2015 26

Familial Hypercholesterolemia (Type II Hyperlipoproteinemia)-Pipeline by Pfizer Inc., H2 2015 27

Familial Hypercholesterolemia (Type II Hyperlipoproteinemia)-Pipeline by Regeneron Pharmaceuticals, Inc., H2 2015 28

Familial Hypercholesterolemia (Type II Hyperlipoproteinemia)-Pipeline by RegenxBio Inc., H2 2015 29

Familial Hypercholesterolemia (Type II Hyperlipoproteinemia)-Pipeline by Sanofi, H2 2015 30

Familial Hypercholesterolemia (Type II Hyperlipoproteinemia)-Pipeline by Thetis Pharmaceuticals LLC, H2 2015 31

Assessment by Monotherapy Products, H2 2015 32

Assessment by Combination Products, H2 2015 33

Number of Products by Stage and Target, H2 2015 35

Number of Products by Stage and Mechanism of Action, H2 2015 37

Number of Products by Stage and Route of Administration, H2 2015 39

Number of Products by Stage and Molecule Type, H2 2015 41

Familial Hypercholesterolemia (Type II Hyperlipoproteinemia) Therapeutics-Recent Pipeline Updates, H2 2015 69

Familial Hypercholesterolemia (Type II Hyperlipoproteinemia)-Dormant Projects, H2 2015 90

Familial Hypercholesterolemia (Type II Hyperlipoproteinemia)-Discontinued Products, H2 2015 91

List of Figures

Number of Products under Development for Familial Hypercholesterolemia (Type II Hyperlipoproteinemia), H2 2015 10

Number of Products under Development for Familial Hypercholesterolemia (Type II Hyperlipoproteinemia)-Comparative Analysis, H2 2015 11

Number of Products under Development by Companies, H2 2015 12

Comparative Analysis by Late Stage Development, H2 2015 15

Comparative Analysis by Early Stage Products, H2 2015 17

Assessment by Monotherapy Products, H2 2015 32

Number of Products by Top 10 Targets, H2 2015 34

Number of Products by Stage and Top 10 Targets, H2 2015 34

Number of Products by Top 10 Mechanism of Actions, H2 2015 36

Number of Products by Stage and Top 10 Mechanism of Actions, H2 2015 36

Number of Products by Routes of Administration, H2 2015 38

Number of Products by Stage and Routes of Administration, H2 2015 38

Number of Products by Molecule Types, H2 2015 40

Number of Products by Stage and Molecule Types, H2 2015 40

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Aegerion Pharmaceuticals, Inc.

Cerenis Therapeutics Holding SA

CymaBay Therapeutics, Inc.

Gemphire Therapeutics Inc.

Merck & Co., Inc.

Pfizer Inc.

Regeneron Pharmaceuticals, Inc.

RegenxBio Inc.

Sanofi

Thetis Pharmaceuticals LLC

Familial Hypercholesterolemia (Type II Hyperlipoproteinemia) Therapeutic Products under Development, Key Players in Familial Hypercholesterolemia (Type II Hyperlipoproteinemia) Therapeutics, Familial Hypercholesterolemia (Type II Hyperlipoproteinemia) Pipeline Overview, Familial Hypercholesterolemia (Type II Hyperlipoproteinemia) Pipeline, Familial Hypercholesterolemia (Type II Hyperlipoproteinemia) Pipeline Assessment

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