Cardiovascular Disease: Recent Drug Advances and Impending Risks

NEW YORK, July 22, 2013 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:

Cardiovascular Disease: Recent Drug Advances and Impending Risks
http://www.reportlinker.com/p01556669/Cardiovascular-Disease-Recent-Drug-Advances-and-Impending-Risks .html#utm_source=prnewswire&utm_medium=pr&utm_campaign=Drug_and_Medication

There are nearly 300 medicines in clinical development to treat cardiovascular disease. This new research report examines in detail the key areas of the cardiovascular (CV) market, gathering inside opinion of cardiologists, to highlight the dynamic changes that are underway in this multibillion dollar marketplace.

Successful players will, necessarily, need to cannibalise their existing cardiovascular franchises in order to limit the impact of generic erosion when their patents expire, whilst at the same time investing in alternative therapies with better, more efficacious outcomes. This is a significant challenge given the high barrier to entry and unmet clinical needs. Not only is cardiovascular disease a "Silent Killer", it is also a commercial time bomb where the risk/reward ratio for any company willing to participate needs to be carefully considered.

This report provides you with a systematic appraisal into the current and future CV market, including...

A detailed review of the leading brands and how they are being positioned in the market, in addition to the potential impact of generics

Assessment of key products in development, identifying 'Ones to Watch' in late-stage clinical development where proof of concept data has been established
Review of products that are 'Waiting in the Wings' in early-stage clinical development where Point-of-Care data is being gathered
Analysis of the potential of 'Long Shots' which represent new and innovative products where the scientific rationale has yet to be fully tested

Antilipidemics

The lowering of 'bad cholesterol' or low-density lipoprotein cholesterol (LDL-C) and triglycerides (TGs) has been shown to reduce the chance of a heart attack and death in people who have an elevated risk of developing heart disease or who already have heart disease. Several drug classes are currently available to treat a range of lipid disorders; each has a different mechanism of action, safety profile and impact on blood lipid profiles to different degrees.

Key drugs covered by the report include

Leading brands - Lipitor (Pfizer), Crestor (AstraZeneca), Livalo (Kowa and Partners), etc...
Recent generics - Atorvastatin, etc...
Ones to watch - Alirocumab (Sanofi/Regeneron Pharmaceuticals), AMG 145 (Amgen), Anacetrapid (Merck & Co), etc...
Waiting in the wings - RG 7652 (Roche), RN-316 (Pfizer), DRL-17822 (Dr Reddy), etc...
Long shots - ALN PCS (Alnylam/The Medicine Company), etc...
Just some of the key questions answered include

Why are statins the gold stand in lipid lowering therapies and which is the most effective at lowering LDL-C?
Will AstraZeneca's Crestor win its fight for supremacy before generic rosuvastatin reaches the market?
Why are PCSK9 inhibitors important to cardiologists and which drugs are leading the field?
Kynamro approved in the US but not in Europe… what next?
What new HDL-C modulating therapies are in development?
What new products are in development from BMS/Simcere; Dr Reddy and DezimaPharma?

Anticoagulants

Anticoagulant therapy is the mainstay for the prevention and treatment of thrombotic complications. Doctors commonly give patients anticoagulation therapy during invasive procedures such as angioplasty or coronary stents as well as during elective knee and hip replacement surgery and abdominal surgery where there is an increased risk of blood clots. In addition, patients with an increased risk of thrombosis and/or thromboembolism such as those with acute coronary syndrome (ACS), those suffering with atrial fibrillation (AF; an erratic heart beat) or those with a history of stroke, are often treated with anticoagulant medicines to improve clinical outcomes.

Key drugs covered by the report include

Leading brands - Coumadin (Bristol-Myers Squibb), Praxada (Boehringer Ingelheim), Xarelto (Bayer/Johnson & Johnson), etc...
Recent generics - Clopidogrel, Enoxaparin sodium, etc...
Ones to watch - Otamixaban (Sanofi), Vorapaxar (Merck & Co.), etc...
Waiting in the wings - Betrixaban (Portola Pharmaceuticals)
Long shots - EP217609 (EndotisPharma), etc…
Just some of the key questions answered include

Have the new OAPs changed the treatment paradigm for patients at high risk from stroke?
Will Effient maintain its head start or will the TRIOLOGY ACS trial cause it to stumble?
What warfarin alternatives have entered the market?
Boehringer Ingelheim's Pradaxa is first to the market but what safety issues have been flagged up?
Why has GlaxoSmithKline's Arixtra failed to impress?
What new anticoagulant drug classes are in development and who is leading the field?

Antihypertensives

High blood pressure or hypertension is a highly prevalent cardiovascular risk factor which is associated with an increased risk of heart attack and stroke. The renin-angiotensin-aldosterone system (RAAS) is widely accepted as the key pathway in the regulation of blood pressure and body volume and has been the target for a cocktail of antihypertensive drugs that include angiotensin receptor blockers (ARBs), angiotensin-converting-enzyme (ACE) inhibitors, aldosterone antagonists and more recently the direct renin inhibitors (DRIs).

Key drugs covered by the report include

Leading brands - Avapro (Sanofi/Bristol-Myers Squibb), Diovan (Novartis), Edarbi (Takeda), etc...
Recent generics - Irbesartan, etc...
Ones to watch - LCZ696 (Novartis), etc...
Waiting in the wings - DSP-9599 (Dainippon Sumitomo Pharma), etc...
Long shots - DARA (Retrophin), etc...

Just some of the key questions answered include

What impact have generics had on the sale of Avapro?
Why have Diovan generics been slow off the mark and have pill combinations offered any protection?
Will Takeda's Edarbi become the new gold standard in a market dominated by generics?
Why has Tekturna not lived up to its promise, do direct renin inhibitors have a future?
What innovative DRIs are in clinical development?
What new drug classes are next in line to transform the antihypertensive market?

Scope of the report 1
Catalyst 1
About the author 2
SECT ION 1: ANTILIPIDEMICS 3
Introduction - where we are now? 3
What is the gold standard lipid lowering therapy? 4
Which statin is most effective at lowering LDL-C? 4
What impact has generic atorvastatin had on Lipitor? 5
What impact has generic Lipitor had on statin prescriptions? 5
Will AstraZeneca's Crestor win the fight for supremacy? 6
When will generic rosuvastatin reach the market? 6
Is statin safety really an issue? 7
Can Livalo differentiation itself from the pack? 7
Statins - Market forecasts 9
New drugs on the block 10
Approach 1: LDL-C reducing therapies: Drug class 1: PSCK9 inhibitors 11
Can new LDL-C reducing therapies supersede statins? 11
Why are PC SK9 inhibitors important to cardiologists? 11
Ones to watch 13
Alirocumab (Sanofi/Regeneron Pharmaceuticals) 13
Sanofi's comprehensive trial program 13
Corporate strategy 14
AMG 145 (Amgen) 14
Amgen's comprehensive trial program 14
Corporate strategy 15
Waiting in the wings 16
RG 7652 (Roche) 16
RN-316 (Pfizer) 16
Long shots 17
ALN PC S (Alnylam/The Medicine Company) 17
PCSK9 inhibitors - Market forecasts 18
Approach 1: LDL-C reducing therapies: Drug class 2: Apo B modulators 20
Sanofi's Kynamro approved in the US but not in Europe… what next? 20
Why have MTP inhibitors established a niche in hoFH patients? 20
Juxtapid (Aegerion Pharmaceuticals) 20
Waiting in the wings 22
Apo B modulators – Market Forecasts 23
Approach 2: HDL-C modulating therapies: Drug class 3: CETP inhibitors 24
Is HDL-C elevation a feasible alternative to LDL-C lowering strategies in lipid control? 24
Does niacin have a future following the withdrawal of Merck's Tredaptive? 24
What new HDL-C modulation therapies are in development? 25
Can the new CEPT inhibitors succeed where others have failed? 25
Ones to watch 27
Anacetrapid (Merck) 27
Evacetrapid (Eli Lilly) 28
Waiting in the wings 29
DRL-17822 (Dr Reddy) 29
BAY 60–5521 (Bayer Healthcare AG) 29
BMS-795311 (Bristol-Myers Squibb/Simcere Pharmaceutical Group) 29
DEZ-001 (Dezima Pharma) 29
Long shots 30
ATH03 (AFF iRiS AG) 30
CETP inhibitors - Market forecasts 31
Approach 2: HDL-C modulating therapies: Drug class 4: Apo A-1 mimetics 32
Are apoliproprotein A-I enhancing agents commercially viable? 32
Ones to watch 33
RVX-208 (Resverlogix) 33
Waiting in the wings 34
Reverse D-4F (Abbott/Arisaph Pharmaceuticals) 34
Apo A-1 enhancing compounds, what the future holds (market forecasts) 35
Antilipidemics overall conclusions 36
SECT ION 2: ANTICO AGULANTS 38
Introduction – where we are now 38
Oral anticoagulant agents 39
Which warfarin alternatives have entered the market? 39
To bleed or not to bleed that is the question? 40
Boehringer Ingelheim's Pradaxa is first to market… 40
… but safety issues have been flagged up? 41
When will BI seek approval for Pradaxa in the long-term prevention of recurrent VTEs? 41
Xarelto is second to market … 41
…but Bayer's expectations are high 41
Why has Xarelto had a mixed response from regulators in ACS patients? 42
EXPLORER program underway to fuel future growth 42
Pfizer/BMS Eliquis potentially has a "best in class" profile 43
Seeking to file for new indication by end of 2013 43
Can Daiichi-Sankyo's Lixiana gain a foothold in the oral factor Xa market 43
Oral anticoagulants – Market forecasts 44
Parenteral anticoagulants 45
Lovenox biosimilars are encroaching on the market 45
Why has GSK's Arixtra failed to impress? 45
Parenteral anticoagulants - Market forecasts 46
Oral antiplatelet agents 47
Have the new OAPs changed the treatment paradigm for patients at high risk from stroke? 48
Will Effient maintain its head start or will the TRIOLOGY ACS trial cause it to stumble? 49
Can AstraZeneca get Brilinta back on track? 49
Oral antiplatelet agents - Market forecasts 51
New drugs on the block 52
Approach 1: Anticoagulant therapies: Drug Class 1: Factor Xa inhibitors 53
Ones to watch 54
Otamixaban (Sanofi) 54
Waiting in the wings 55
Betrixaban (Portola Pharmaceuticals) 55
Long shot 56
EP 217609 (Endotis Pharma) 56
Factor Xa inhibitors - Market forecasts 57
Approach 1: Anticoagulant therapies: Drug Class 2: ultra LMWHs 58
Long shots 59
Adomiparin (Momenta Pharmaceuticals) 59
Ultra LMWH - Market forecasts 60
Approach 2: Antiplatelet therapies: Drug Class 3: P2Y inhibitors 61
Ones to watch 62
Cangrelor IV (The Medicine Company) 62
P2Y inhibitors - Market forecasts 63
Approach 2: Antiplatelet therapies: Drug Class 4: PAR1 inhibitors 64
Ones to watch 65
Vorapaxar (Merck) 65
PAR1 inhibitors - Market forecasts 66
Anticoagulant overall conclusions 67
SECT ION 3: ANTIHYPERTE NSIVES 68
Introduction – Where we are now 68
The hypertension market is driven by generics 69
Avapro's has witnessed aggressive generic erosion… 69
But why have Diovan generics been slow off the mark? 70
Will Takeda's Edarbi become the new gold standard? 70
Why has Tekturna not lived up to its promise? 70
Antihypertensives - Market forecasts 72
New drugs on the block 73
Approach 1: RAAS modulators: Drug Class 1: Oral direct renin inhibitor 74
Waiting in the wings 75
VTP-27999 (Vitae Pharmaceuticals) 75
Direct renin inhibitors – Market forecasts 76
Approach 1: RAAS modulators: Drug Class 2: Dual acting compounds 77
Ones to watch 78
LCZ696 (Novartis) 78
Long shot 79
DARA (Retrophin) 79
Dual acting compounds – Market forecasts 80
Approach 1: RAAS modulators: Drug Class 3: sGC stimulators 81
Ones to watch 82
Riociguat (Bayer) 82
cGS stimulator – Market forecasts 83
Approach 1: RAAS modulators: Drug Class 4: NRP-A agonist 84
Long shots 85
PL-3994 (Palatin Technologies) 85
NRP-A agonist – Market forecasts 86
Antihypertensives overall conclusions 87
Appendix 1 88
Mechanism of PC SK9 inhibitors 88
Appendix 2 89
Alirocumab clinical trial data 89
Appendix 3 90
AMG 415 clinical trial data 90
Appendix 4 92
Mechanism of CETP inhibition 92
Appendix 5 93
Ancetrapid's clinical trial data 93
Appendix 6 94
Evacetrapid clinical trial data 94
Appendix 7 95
Mechanism of apoA-1 mimetic 95
Appendix 8 96
The coagulation cascade 96
Appendix 9 97
Cangrelor IV clinical trial data 97
Appendix 10 98
The renin-angiotensin-aldosterone system (RAAS) 98
Methodology 99
Primary research 99
Secondary research 99
Acronyms 100
References 102
ENDNOTE S 106

List of Tables

Table 1: Cardiovascular agents by category 1
Table 2: Lipid-lowering agents, mechanism of action, safety profile and lipid profile 3
Table 3: Leading statin drugs and combinations 4
Table 4: Statins on LDL-C reduction and use in moderate to high risk patients with lipid disorders 4
Table 5: Lipitor's sales decline, 2010-2012 (sales US$mn) 5
Table 6: Crestor's sales being challenged, 2010-2012 (sales US$mn) 6
Table 7: Statin sales forecast (US$mn), 2011-2017 9
Table 8: Strategies and targets to modulate LDL-C levels 11
Table 9: PCSK9 inhibitors in development 11
Table 10: PCSK9 inhibitor sales forecast (US$mn), 2011-2017 19
Table 11: Lipid lowering effects of Juxtapid 21
Table 12: Novel developmental candidates in early stages of development 22
Table 13: Apo B modulator sales forecast (US$mn), 2011-2017 23
Table 14: Strategies and targets to modulate HDL-C levels 25
Table 15: CETP inhibitors in development 26
Table 16: Potency and efficacy of leading CETP inhibitors, (% change) 27
Table 17: CETP inhibitor sales forecast (US$mn), 2011-2017 31
Table 18: Apo A-1 enhancing drugs in development 32
Table 19: Apo A-I enhancing agent sales forecast (US$mn), 2011-2017 35
Table 20: Summary of approved and new drugs in development 37
Table 21: Commonly prescribed anticoagulant agents, mechanism of action and safety profile 38
Table 22: New oral anticoagulants, approval in patient populations 39
Table 23: Headline results from Phase III trials of new anticoagulants versus warfarin in AF 40
Table 24: Oral anticoagulant sales forecast (US$mn), 2011-2017 44
Table 25: Forecast for leading parenteral anticoagulants (US$mn), 2011-2017 46
Table 26: Oral anticoagulants potential patient populations 50
Table 27: Leading OAP drug sales forecast (US$mn), 2011-2017 51
Table 28: Novel factor Xa inhibitors 53
Table 29: Factor Xa inhibitors sales forecast (US$mn), 2011-2017 57
Table 30: Novel ultra LMWH 58
Table 31: Ultra LMWH sales forecast (US$mn), 2011-2017 60
Table 32: Novel antiplatelet agents in development 61
Table 33: P2Y inhibitor sales forecast (US$mn), 2011-2017 63
Table 34: Novel PAR1 inhibitors in development 64
Table 35: PAR1 inhibitors sales forecast (US$mn), 2011-2017 66
Table 36: Summary of approved and new drugs in development 67
Table 37: Commonly prescribed antihypertensive agents, mechanism of action and safety profile 68
Table 38: Leading ARBs and generic availability 69
Table 39: Avapro's sales, 2011-2012 (sales €mn) 69
Table 40: Diovan sales, 2011-2012 (sales US$mn) 70
Table 41: Tekturna fixed combinations 71
Table 42: Leading ARB sales forecasts (US$mn), 2011-2017 72
Table 43: DRI sales forecast (US$mn), 2011-2017 72
Table 44: Novel DRIs in clinical development 74
Table 45: DTI inhibitors sales forecast (US$mn), 2012-2017 76
Table 46: Novel dual acting compounds in clinical development 77
Table 47: Dual acting compounds sales forecast (US$mn), 2012-2017 80
Table 48: sGC stimulators sales forecast (US$mn), 2011-2017 83
Table 49: NRP-A agonist sales forecast, 2011-2017 86
Table 50: Summary of approved and new antihypertensive drugs in development 87
Table 51: Summary of DFI11565 trial data in primary hypercholesterolemia patients at 12 weeks 89
Table 52: Summary of trial data in heFH patients at 12 weeks 89
Table 53: Summary of LAPLACE-TIMI 57 data in 631 primary hypercholesterolemia patients at 12 weeks 90
Table 54: Summary of MENDEL data in primary hypercholesterolemia at 12 weeks 90
Table 55: Summary of RUTHERFORD data in heFH patients at 12 weeks 90
Table 56: Summary of GUASS data in patients intolerant to statins at 12 weeks 91
Table 57: Summary of anacetrapid monotherapy data (change from baseline) at 24 weeks 93
Table 58: Summary of evacetrapid monotherapy data (change from baseline) at 24 weeks 94
Table 59: Summary of evacetrapid combination data (change from baseline) at 24 weeks 94

List of Charts

Figure 1: Medicines under development of heart disease and stroke 10
Figure 2: Sanofi/Regeneron's comprehensive alirocumab Phase III program 13
Figure 3: Amgen's comprehensive AMG 145 Phase III program 15
Figure 4: Xarelto's EXPLORER program 42
Figure 5: Oral antiplatelet market by region, 2012 47
Figure 6: Oral antiplatelet market by volume, 2012 47
Figure 7: Oral antiplatelet market, market share of leading agents in leading markets, 2012 48
Figure 8: Medicines under development of heart disease and stroke 52
Figure 9: Medicines under development of heart disease and stroke 73
Figure 10: Schematic mechanism of action of PCSK9 in the liver 88
Figure 11: Schematic mechanism of action of CETP inhibitors 92
Figure 12: Schematic mechanism of action of Apo A-1 enhancing agents 95
Figure 13: Schematic of clotting cascade and site of action of approved anticoagulant drugs 96
Figure 14: Schematic of the renin-angiotensin-aldosterone system 98

To order this report:
Drug_and_Medication Industry:
Cardiovascular Disease: Recent Drug Advances and Impending Risks


Contact Clare: clare@reportlinker.com  
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