Hypercholesterolemia - Pipeline Review, H2 2012

Global Markets Direct, September 2012, Pages: 132

Hypercholesterolemia – Pipeline Review, H2 2012

Summary

Global Markets Direct’s, 'Hypercholesterolemia - Pipeline Review, H2 2012', provides an overview of the indication’s therapeutic pipeline. This report provides information on the therapeutic development for Hypercholesterolemia, complete with latest updates, and special features on late-stage and discontinued projects. It also reviews key players involved in the therapeutic development for Hypercholesterolemia. Hypercholesterolemia - Pipeline Review, Half Year 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.

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

Scope

- A snapshot of the global therapeutic scenario for Hypercholesterolemia.
- A review of the Hypercholesterolemia products under development by companies and universities/research institutes based on information derived from company and industry-specific sources.
- Coverage of products based on various stages of development ranging from discovery till registration stages.
- A feature on pipeline projects on the basis of monotherapy and combined therapeutics.
- Coverage of the Hypercholesterolemia pipeline on the basis of route of administration and molecule type.
- Key discontinued pipeline projects.
- Latest news and deals relating to the products.

Reasons to buy

- Identify and understand important and diverse types of therapeutics under development for Hypercholesterolemia.
- Identify emerging players with potentially strong product portfolio and design effective counter-strategies to gain competitive advantage.
- Plan mergers and acquisitions effectively by identifying 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.

2
List of Tables 7
List of Figures 8
Introduction 9
REPORT COVERAGE 9
Hypercholesterolemia Overview 10
Therapeutics Development 11
An Overview of Pipeline Products for Hypercholesterolemia 11
Hypercholesterolemia Therapeutics under Development by Companies 13
Hypercholesterolemia Therapeutics under Investigation by Universities/Institutes 16
Late Stage Products 17
Comparative Analysis 17
Mid Clinical Stage Products 18
Comparative Analysis 18
Early Clinical Stage Products 19
Comparative Analysis 19
Discovery and Pre-Clinical Stage Products 20
Comparative Analysis 20
Hypercholesterolemia Therapeutics – Products under Development by Companies 21
Hypercholesterolemia Therapeutics – Products under Investigation by Universities/Institutes 22
Companies Involved in Hypercholesterolemia Therapeutics Development 23
Bristol-Myers Squibb Company 23
Genzyme Corporation 24
Amgen Inc. 25
Eli Lilly and Company 26
Tekmira Pharmaceuticals Corp. 27
Merck & Co., Inc. 28
Novartis AG 29
MDRNA, Inc. 30
Pfizer Inc. 31
Santaris Pharma A/S 32
Aegerion Pharmaceuticals, Inc. 33
ReGenX Biosciences, LLC 34
Alnylam Pharmaceuticals, Inc 35
Regeneron Pharmaceuticals, Inc. 36
Ache Laboratorios Farmaceuticos S/A 37
Relypsa, Inc. 38
Esperion Therapeutics, Inc. 39
Madeira Therapeutics 40
Hypercholesterolemia – Therapeutics Assessment 41
Assessment by Monotherapy Products 41
Assessment by Combination Products 42
Assessment by Route of Administration 43
Assessment by Molecule Type 45
Drug Profiles 47
anacetrapib - Drug Profile 47
Product Description 47
Mechanism of Action 47
R&D Progress 47
mipomersen sodium - Drug Profile 49
Product Description 49
Mechanism of Action 49
R&D Progress 49
MK-0524A - Drug Profile 51
Product Description 51
Mechanism of Action 51
R&D Progress 51
MK-0524A - Drug Profile 53
Product Description 53
Mechanism of Action 53
R&D Progress 53
SPC-4955 - Drug Profile 55
Product Description 55
Mechanism of Action 55
R&D Progress 55
THR-ß 3196 - Drug Profile 56
Product Description 56
Mechanism of Action 56
R&D Progress 56
ALN-PCS - Drug Profile 57
Product Description 57
Mechanism of Action 57
R&D Progress 57
TKM-ApoB - Drug Profile 58
Product Description 58
Mechanism of Action 58
R&D Progress 58
AEGR-733 - Drug Profile 60
Product Description 60
Mechanism of Action 60
R&D Progress 60
ETC-1002 - Drug Profile 62
Product Description 62
Mechanism of Action 62
R&D Progress 62
MDR-04227 - Drug Profile 64
Product Description 64
Mechanism of Action 64
R&D Progress 64
alipogene tiparvovec - Drug Profile 65
Product Description 65
Mechanism of Action 65
R&D Progress 65
alipogene tiparvovec - Drug Profile 67
Product Description 67
Mechanism of Action 67
R&D Progress 67
REGN-727 - Drug Profile 69
Product Description 69
Mechanism of Action 69
R&D Progress 69
BMS-823778 - Drug Profile 72
Product Description 72
Mechanism of Action 72
R&D Progress 72
LY-2484595 + Atorvastatin - Drug Profile 74
Product Description 74
Mechanism of Action 74
R&D Progress 74
LY2484595 + Simvastatin - Drug Profile 75
Product Description 75
Mechanism of Action 75
R&D Progress 75
LY2484595 + Rosuvastatin - Drug Profile 77
Product Description 77
Mechanism of Action 77
R&D Progress 77
MK-0653C - Drug Profile 78
Product Description 78
Mechanism of Action 78
R&D Progress 78
LCQ-908 - Drug Profile 80
Product Description 80
Mechanism of Action 80
R&D Progress 80
AMG-145 - Drug Profile 81
Product Description 81
Mechanism of Action 81
R&D Progress 81
evacetrapib - Drug Profile 83
Product Description 83
Mechanism of Action 83
R&D Progress 83
BMS-770767 - Drug Profile 84
Product Description 84
Mechanism of Action 84
R&D Progress 84
RN-316 - Drug Profile 85
Product Description 85
Mechanism of Action 85
R&D Progress 85
atorvastatin calcium - Drug Profile 86
Product Description 86
Mechanism of Action 86
R&D Progress 86
RLY-106 - Drug Profile 87
Product Description 87
Mechanism of Action 87
R&D Progress 87
REGN727 + Atorvastatin - Drug Profile 88
Product Description 88
Mechanism of Action 88
R&D Progress 88
atorvastatin calcium - Drug Profile 90
Product Description 90
Mechanism of Action 90
R&D Progress 90
ezetimibe - Drug Profile 91
Product Description 91
Mechanism of Action 91
R&D Progress 91
rosuvastatin calcium - Drug Profile 92
Product Description 92
Mechanism of Action 92
R&D Progress 92
BMS-962476 - Drug Profile 93
Product Description 93
Mechanism of Action 93
R&D Progress 93
1D05-Fab - Drug Profile 94
Product Description 94
Mechanism of Action 94
R&D Progress 94
Rosuvastatin + Ezetimibe - Drug Profile 96
Product Description 96
Mechanism of Action 96
R&D Progress 96
LGT-209 - Drug Profile 97
Product Description 97
Mechanism of Action 97
R&D Progress 97
Drug For Familial Hypercholesterolemia - Drug Profile 98
Product Description 98
Mechanism of Action 98
R&D Progress 98
HeartVax - Drug Profile 99
Product Description 99
Mechanism of Action 99
R&D Progress 99
BMS-852927 - Drug Profile 100
Product Description 100
Mechanism of Action 100
R&D Progress 100
Hypercholesterolemia Therapeutics – Drug Profile Updates 101
Hypercholesterolemia Therapeutics – Discontinued Products 121
Hypercholesterolemia Therapeutics - Dormant Products 122
Hypercholesterolemia – Product Development Milestones 123
Featured News & Press Releases 123
Aug 26, 2012: Merck Provides Update On Anacetrapib Development Program 123
Aug 26, 2012: Merck Provides Update On Tredaptive Development Program 124
Aug 14, 2012: Aegerion Pharma Announces Date Of FDA Advisory Committee Review Of Lomitapide NDA 124
Aug 13, 2012: Ranbaxy Shifts Production Of Generic Lipitor To Mohali, India 124
Jul 20, 2012: Sanofi And Regeneron Pharma Launch Comprehensive Phase III Clinical Program With LDL Cholesterol-Lowering PCSK9 Antibody 124
Jun 06, 2012: Tai Tien Pharma Launches Pitavastatin Calcium In Taiwan 126
May 29, 2012: Aegerion Announces Oral Presentation Of Phase III Lomitapide Data At European Atherosclerosis Society Conference 127
May 29, 2012: AstraZeneca Continues To Support Patients On CRESTOR 127
May 29, 2012: Genzyme And Isis Announce Filing Of NDA For KYNAMRO In Homozygous Familial Hypercholesterolemia 128
May 26, 2012: Sanofi And Regeneron Pharma Announce Publication Of Positive Phase II Results Of Lipid-Lowering PCSK9 Antibody In The Lancet 129
Appendix 131
Methodology 131
Coverage 131
Secondary Research 131
Primary Research 131
Expert Panel Validation 131
Contact Us 132
Disclaimer 132

List of Tables
Number of Products Under Development for Hypercholesterolemia, H2 2012 11
Products under Development for Hypercholesterolemia – Comparative Analysis, H2 2012 12
Number of Products under Development by Companies, H2 2012 14
Number of Products under Development by Companies, H2 2012 (Contd..1) 15
Number of Products under Investigation by Universities/Institutes, H2 2012 16
Comparative Analysis by Late Stage Development, H2 2012 17
Comparative Analysis by Mid Clinical Stage Development, H2 2012 18
Comparative Analysis by Early Clinical Stage Development, H2 2012 19
Comparative Analysis by Discovery and Pre-Clinical Stage Development, H2 2012 20
Products under Development by Companies, H2 2012 21
Products under Investigation by Universities/Institutes, H2 2012 22
Bristol-Myers Squibb Company, H2 2012 23
Genzyme Corporation, H2 2012 24
Amgen Inc., H2 2012 25
Eli Lilly and Company, H2 2012 26
Tekmira Pharmaceuticals Corp., H2 2012 27
Merck & Co., Inc., H2 2012 28
Novartis AG, H2 2012 29
MDRNA, Inc., H2 2012 30
Pfizer Inc., H2 2012 31
Santaris Pharma A/S, H2 2012 32
Aegerion Pharmaceuticals, Inc., H2 2012 33
ReGenX Biosciences, LLC, H2 2012 34
Alnylam Pharmaceuticals, Inc, H2 2012 35
Regeneron Pharmaceuticals, Inc., H2 2012 36
Ache Laboratorios Farmaceuticos S/A, H2 2012 37
Relypsa, Inc., H2 2012 38
Esperion Therapeutics, Inc., H2 2012 39
Madeira Therapeutics, H2 2012 40
Assessment by Monotherapy Products, H2 2012 41
Assessment by Combination Products, H2 2012 42
Assessment by Stage and Route of Administration, H2 2012 44
Assessment by Stage and Molecule Type, H2 2012 46
Hypercholesterolemia Therapeutics – Drug Profile Updates 101
Hypercholesterolemia Therapeutics – Discontinued Products 121
Hypercholesterolemia Therapeutics – Dormant Products 122

List of Figures
Number of Products under Development for Hypercholesterolemia, H2 2012 11
Products under Development for Hypercholesterolemia – Comparative Analysis, H2 2012 12
Products under Development by Companies, H2 2012 13
Products under Investigation by Universities/Institutes, H2 2012 16
Late Stage Products, H2 2012 17
Mid Clinical Stage Products, H2 2012 18
Early Clinical Stage Products, H2 2012 19
Discovery and Pre-Clinical Stage Products, H2 2012 20
Assessment by Monotherapy Products, H2 2012 41
Assessment by Combination Products, H2 2012 42
Assessment by Route of Administration, H2 2012 43
Assessment by Stage and Route of Administration, H2 2012 44
Assessment by Molecule Type, H2 2012 45
Assessment by Stage and Molecule Type, H2 2012 46

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