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Cardiovascular Disease: Recent Drug Advances and Impending Risks

October 14, 2013

Reportbuyer.com just published a new market research report: Cardiovascular Disease: Recent Drug Advances and Impending Risks.

London (PRWEB) October 14, 2013

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

Read the full report:

Cardiovascular Disease: Recent Drug Advances and Impending Risks

http://www.reportbuyer.com/pharma_healthcare/therapeutic/cardiovascular_disease_recent_drug_advances_impending_risks.html#utm_source=prnewswire&utm_medium=pr&utm_campaign=Drug_and_Medication

For more information:

Sarah Smith

Research Advisor at Reportbuyer.com

Email: query@reportbuyer.com

Tel: +44 208 816 85 48

Website: http://www.reportbuyer.com/

For the original version on PRWeb visit: http://www.prweb.com/releases/2013/10/prweb11227545.htm


Source: prweb



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