Hypercholesterolemia - Pipeline Review, H1 2014

Hypercholesterolemia - Pipeline Review, H1 2014

Summary

Global Markets Direct’s, ‘Hypercholesterolemia - Pipeline Review, H1 2014’, provides an overview of the Hypercholesterolemia’s therapeutic pipeline.

This report provides comprehensive information on the therapeutic development for Hypercholesterolemia, 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 Hypercholesterolemia 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 Hypercholesterolemia
- 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 Hypercholesterolemia and enlists all their major and minor projects
- The report summarizes all the dormant and discontinued pipeline projects
- A review of the Hypercholesterolemia 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 Hypercholesterolemia 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 Hypercholesterolemia
- Plan mergers and acquisitions effectively by identifying key players of the most promising pipeline
- Devise corrective measures for pipeline projects by understanding Hypercholesterolemia 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

Table of Contents
Table of Contents 2
List of Tables 8
List of Figures 9
Introduction 10
Global Markets Direct Report Coverage 10
Hypercholesterolemia Overview 11
Therapeutics Development 12
Pipeline Products for Hypercholesterolemia - Overview 12
Pipeline Products for Hypercholesterolemia - Comparative Analysis 13
Hypercholesterolemia - Therapeutics under Development by Companies 14
Hypercholesterolemia - Therapeutics under Investigation by Universities/Institutes 17
Hypercholesterolemia - Pipeline Products Glance 18
Late Stage Products 18
Clinical Stage Products 19
Early Stage Products 20
Unknown Stage Products 21
Hypercholesterolemia - Products under Development by Companies 22
Hypercholesterolemia - Products under Investigation by Universities/Institutes 24
Hypercholesterolemia - Companies Involved in Therapeutics Development 25
Bristol-Myers Squibb Company 25
Johnson & Johnson 26
Eli Lilly and Company 27
Merck & Co., Inc. 28
Pfizer Inc. 29
Santaris Pharma A/S 30
Alnylam Pharmaceuticals, Inc. 31
Regeneron Pharmaceuticals, Inc. 32
Catabasis Pharmaceuticals, Inc. 33
Planet Biotechnology Inc. 34
Zhejiang Hisun Pharmaceutical Co., Ltd. 35
Relypsa, Inc. 36
Esperion Therapeutics, Inc. 37
Serometrix, LLC 38
FORMAC Pharmaceuticals N.V. 39
Madeira Therapeutics 40
Immune Response BioPharma, Inc. 41
NanoForm Therapeutics Ltd. 42
Lumena Pharmaceuticals, Inc. 43
LondonPharma Ltd 44
Dybly AG 45
Amgen Astellas BioPharma K.K. 46
Hypercholesterolemia - Therapeutics Assessment 47
Assessment by Monotherapy Products 47
Assessment by Target 48
Assessment by Mechanism of Action 51
Assessment by Route of Administration 54
Assessment by Molecule Type 56
Drug Profiles 59
anacetrapib - Drug Profile 59
Product Description 59
Mechanism of Action 59
R&D Progress 59
alirocumab - Drug Profile 61
Product Description 61
Mechanism of Action 61
R&D Progress 61
evolocumab - Drug Profile 64
Product Description 64
Mechanism of Action 64
R&D Progress 64
bococizumab - Drug Profile 66
Product Description 66
Mechanism of Action 66
R&D Progress 66
ETC-1002 - Drug Profile 67
Product Description 67
Mechanism of Action 67
R&D Progress 67
Alpha Cyclodextrin - Drug Profile 69
Product Description 69
Mechanism of Action 69
R&D Progress 69
evolocumab - Drug Profile 70
Product Description 70
Mechanism of Action 70
R&D Progress 70
BMS-770767 - Drug Profile 72
Product Description 72
Mechanism of Action 72
R&D Progress 72
bococizumab - Drug Profile 73
Product Description 73
Mechanism of Action 73
R&D Progress 73
LY-3015014 - Drug Profile 74
Product Description 74
Mechanism of Action 74
R&D Progress 74
CAT-2003 - Drug Profile 75
Product Description 75
Mechanism of Action 75
R&D Progress 75
SPC-4955 - Drug Profile 77
Product Description 77
Mechanism of Action 77
R&D Progress 77
MGL-3196 - Drug Profile 78
Product Description 78
Mechanism of Action 78
R&D Progress 78
ALN-PCS02 - Drug Profile 80
Product Description 80
Mechanism of Action 80
R&D Progress 80
SPC-5001 - Drug Profile 81
Product Description 81
Mechanism of Action 81
R&D Progress 81
BMS-962476 - Drug Profile 82
Product Description 82
Mechanism of Action 82
R&D Progress 82
ralpancizumab - Drug Profile 83
Product Description 83
Mechanism of Action 83
R&D Progress 83
BMS-852927 - Drug Profile 84
Product Description 84
Mechanism of Action 84
R&D Progress 84
fenofibrate - Drug Profile 86
Product Description 86
Mechanism of Action 86
R&D Progress 86
simvastatin - Drug Profile 87
Product Description 87
Mechanism of Action 87
R&D Progress 87
fluvastatin sodium - Drug Profile 88
Product Description 88
Mechanism of Action 88
R&D Progress 88
pravastatin sodium - Drug Profile 89
Product Description 89
Mechanism of Action 89
R&D Progress 89
LUM-002 - Drug Profile 90
Product Description 90
Mechanism of Action 90
R&D Progress 90
PF-06678552 - Drug Profile 91
Product Description 91
Mechanism of Action 91
R&D Progress 91
HS-25 - Drug Profile 92
Product Description 92
Mechanism of Action 92
R&D Progress 92
ALN-PCS02 - Drug Profile 93
Product Description 93
Mechanism of Action 93
R&D Progress 93
RLY-106 - Drug Profile 95
Product Description 95
Mechanism of Action 95
R&D Progress 95
atorvastatin calcium - Drug Profile 96
Product Description 96
Mechanism of Action 96
R&D Progress 96
1D05-Fab - Drug Profile 97
Product Description 97
Mechanism of Action 97
R&D Progress 97
IR-1002 - Drug Profile 98
Product Description 98
Mechanism of Action 98
R&D Progress 98
PCSK-9 Program - Drug Profile 99
Product Description 99
Mechanism of Action 99
R&D Progress 99
Aplexone - Drug Profile 100
Product Description 100
Mechanism of Action 100
R&D Progress 100
DYB-186 - Drug Profile 101
Product Description 101
Mechanism of Action 101
R&D Progress 101
Small Molecule To Inhibit Endothelial Lipase For Hypercholesterolemia - Drug Profile 102
Product Description 102
Mechanism of Action 102
R&D Progress 102
EP-80317 - Drug Profile 103
Product Description 103
Mechanism of Action 103
R&D Progress 103
ezetimibe - Drug Profile 104
Product Description 104
Mechanism of Action 104
R&D Progress 104
EGF-A Peptide - Drug Profile 105
Product Description 105
Mechanism of Action 105
R&D Progress 105
SX-PCK9 - Drug Profile 106
Product Description 106
Mechanism of Action 106
R&D Progress 106
Diiodothyropropionic Acid - Drug Profile 107
Product Description 107
Mechanism of Action 107
R&D Progress 107
EGF-AB Fc Variants to Inhibit PCSK9 for Hypercholesterolemia - Drug Profile 108
Product Description 108
Mechanism of Action 108
R&D Progress 108
MT-001 - Drug Profile 110
Product Description 110
Mechanism of Action 110
R&D Progress 110
Hypercholesterolemia - Recent Pipeline Updates 111
Hypercholesterolemia - Dormant Projects 131
Hypercholesterolemia - Discontinued Products 133
Hypercholesterolemia - Product Development Milestones 134
Featured News & Press Releases 134
Dec 19, 2013: Sanofi and Regeneron Announce Collaboration with American College of Cardiology for PCSK9 Inhibitor Clinical Program 134
Dec 19, 2013: Amgen Announces Positive Top-Line Results From 52-Week Phase 3 DESCARTES Study Of Evolocumab In Patients With High Cholesterol 135
Dec 17, 2013: Amgen Announces Positive Top-Line Results From Phase 3 MENDEL-2 Trial Of Evolocumab In Patients With High Cholesterol 137
Nov 18, 2013: Esperion Therapeutics Presents Full Results of Phase 2 Clinical Study Demonstrating that ETC-1002 Lowered LDL-C by an Average of 32 Percent and Was Well Tolerated in Patients with Hypercholesterolemia and History of Statin Intolerance 138
Nov 17, 2013: Alnylam Presents New Pre-clinical Data on RNAi Therapeutics for Cardiovascular Disease at American Heart Association Meeting 139
Nov 11, 2013: Esperion Therapeutics Announces Oral Presentation on ETC-1002 at 2013 Scientific Sessions of the American Heart Association 140
Oct 30, 2013: Esperion Therapeutics Announces Initiation of Phase 2b Clinical Study of ETC-1002 in Patients With or Without Statin Intolerance and Hypercholesterolemia 141
Oct 16, 2013: Sanofi and Regeneron Report Positive Top-line Results with Alirocumab from First Phase 3 Study of a PCSK9 Inhibitor for LDL Cholesterol Reduction 142
Oct 09, 2013: The Medicines Company and Alnylam Advance Development Candidate for ALN-PCSsc, a Subcutaneously Administered RNAi Therapeutic Targeting PCSK9 Under Investigation for the Treatment of Hypercholesterolemia 144
Oct 03, 2013: Alnylam and Collaborators Publish Clinical Trial Results with ALN-PCS, an RNAi Therapeutic Targeting PCSK9 for the Treatment of Hypercholesterolemia, in The Lancet 145
Appendix 148
Methodology 148
Coverage 148
Secondary Research 148
Primary Research 148
Expert Panel Validation 148
Contact Us 149
Disclaimer 149

List of Tables
Number of Products under Development for Hypercholesterolemia, H1 2014 12
Number of Products under Development for Hypercholesterolemia - Comparative Analysis, H1 2014 13
Number of Products under Development by Companies, H1 2014 15
Number of Products under Development by Companies, H1 2014 (Contd..1) 16
Number of Products under Investigation by Universities/Institutes, H1 2014 17
Comparative Analysis by Late Stage Development, H1 2014 18
Comparative Analysis by Clinical Stage Development, H1 2014 19
Comparative Analysis by Early Stage Development, H1 2014 20
Comparative Analysis by Unknown Stage Development, H1 2014 21
Products under Development by Companies, H1 2014 22
Products under Development by Companies, H1 2014 (Contd..1) 23
Products under Investigation by Universities/Institutes, H1 2014 24
Hypercholesterolemia - Pipeline by Bristol-Myers Squibb Company, H1 2014 25
Hypercholesterolemia - Pipeline by Johnson & Johnson, H1 2014 26
Hypercholesterolemia - Pipeline by Eli Lilly and Company, H1 2014 27
Hypercholesterolemia - Pipeline by Merck & Co., Inc., H1 2014 28
Hypercholesterolemia - Pipeline by Pfizer Inc., H1 2014 29
Hypercholesterolemia - Pipeline by Santaris Pharma A/S, H1 2014 30
Hypercholesterolemia - Pipeline by Alnylam Pharmaceuticals, Inc., H1 2014 31
Hypercholesterolemia - Pipeline by Regeneron Pharmaceuticals, Inc., H1 2014 32
Hypercholesterolemia - Pipeline by Catabasis Pharmaceuticals, Inc., H1 2014 33
Hypercholesterolemia - Pipeline by Planet Biotechnology Inc., H1 2014 34
Hypercholesterolemia - Pipeline by Zhejiang Hisun Pharmaceutical Co., Ltd., H1 2014 35
Hypercholesterolemia - Pipeline by Relypsa, Inc., H1 2014 36
Hypercholesterolemia - Pipeline by Esperion Therapeutics, Inc., H1 2014 37
Hypercholesterolemia - Pipeline by Serometrix, LLC, H1 2014 38
Hypercholesterolemia - Pipeline by FORMAC Pharmaceuticals N.V., H1 2014 39
Hypercholesterolemia - Pipeline by Madeira Therapeutics, H1 2014 40
Hypercholesterolemia - Pipeline by Immune Response BioPharma, Inc., H1 2014 41
Hypercholesterolemia - Pipeline by NanoForm Therapeutics Ltd., H1 2014 42
Hypercholesterolemia - Pipeline by Lumena Pharmaceuticals, Inc., H1 2014 43
Hypercholesterolemia - Pipeline by LondonPharma Ltd, H1 2014 44
Hypercholesterolemia - Pipeline by Dybly AG, H1 2014 45
Hypercholesterolemia - Pipeline by Amgen Astellas BioPharma K.K., H1 2014 46
Assessment by Monotherapy Products, H1 2014 47
Number of Products by Stage and Target, H1 2014 50
Number of Products by Stage and Mechanism of Action, H1 2014 53
Number of Products by Stage and Route of Administration, H1 2014 55
Number of Products by Stage and Molecule Type, H1 2014 58
Hypercholesterolemia Therapeutics - Recent Pipeline Updates, H1 2014 111
Hypercholesterolemia - Dormant Projects, H1 2014 131
Hypercholesterolemia - Dormant Projects (Contd..1), H1 2014 132
Hypercholesterolemia - Discontinued Products, H1 2014 133

List of Figures
Number of Products under Development for Hypercholesterolemia, H1 2014 12
Number of Products under Development for Hypercholesterolemia - Comparative Analysis, H1 2014 13
Number of Products under Development by Companies, H1 2014 14
Number of Products under Investigation by Universities/Institutes, H1 2014 17
Comparative Analysis by Clinical Stage Development, H1 2014 19
Comparative Analysis by Early Stage Products, H1 2014 20
Assessment by Monotherapy Products, H1 2014 47
Number of Products by Top 10 Target, H1 2014 48
Number of Products by Stage and Top 10 Target, H1 2014 49
Number of Products by Top 10 Mechanism of Action, H1 2014 51
Number of Products by Stage and Top 10 Mechanism of Action, H1 2014 52
Number of Products by Top 10 Route of Administration, H1 2014 54
Number of Products by Stage and Top 10 Route of Administration, H1 2014 55
Number of Products by Top 10 Molecule Type, H1 2014 56
Number of Products by Stage and Top 10 Molecule Type, H1 2014 57