Commercial Perspectives: Anti-dyslipidemics - A tale of two launches

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Publication Date: 2004-01-30

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Introduction
Anti-dyslipidemics achieved global sales of $21.7 billion in 2002, a growth rate of 12.5% over 2001. Due to the maturing of the market, evidenced by the increasing availability of generic statins, growth in this market has slowed in recent years. However, increasing prevalence of dyslipidemia and the launch of novel adjunctive therapies and statin single-pill combinations will drive future growth

Scope

Evaluation of lifecycle management strategies employed to maximize revenue potential and brand life of agents in all anti-dyslipidemic classes
Analysis of the impacts of patent expiries from 2003 to 2011 in the US, EU and Japan on all first and second generation statins
Evaluation of the initial uptake of Crestor versus Zetia and the longer term potential of these agents over the forecast period to 2011
Assessment of the expanding use of combination therapy, following the launch of novel adjunctive therapies and single-pill combination therapies

Highlights
Due to loss of patent protection in the major markets, Datamonitor forecasts Zocor's global sales to decline to $604m in 2011. In order to minimize this loss in sales, Johnson & Johnson MSD Consumer Pharmaceuticals has applied for OTC status for Zocor in the UK. However, this lifecycle-management strategy is unlikely to maintain Zocor's revenues

The increasing use of combination therapy will enable more patients to achieve target cholesterol goals. As a result, the development of statin single-pill combinations is an active lifecycle-management strategy being pursued by many statin manufacturers, with these therapies forecast to collectively achieve global sales of $4.7 billion in 2011

Zetia and Crestor represent the newest anti-dyslipidemics to reach the US and EU and both agents have been aggressively marketed. The benefit of using Zetia in combination with statins has led to rapid initial uptake. However, Crestor has encountered a number of setbacks since launch and concerns over safety have led to slower initial uptake

Why you should buy this report

To prioritize sales and marketing efforts to effectively counter competitive threats
To select best product lifecycle management strategies to counter generic competition and expand a drug's commercial potential
To optimize licensing decisions based on market potential for inline products and identify optimal R&D development strategies

CHAPTER 1 EXECUTIVE SUMMARY - page 3
- Scope of the analysis - page 3
- Datamonitor insight into the anti-dyslipidemics market - page 4
- Key metrics - page 10
- Evolution of the anti-dyslipidemics market - page 11
TABLE OF CONTENTS - page 13
CHAPTER 2 MARKET SEGMENTATION & DEFINITION - page 21
- Key findings - page 21
- Strategic scoping and focus - page 22
- Market definition - page 22
  - Therapy classes covered - page 22
  - Disease indications - page 23
  - Dyslipidemia - page 23
  - Cardiovascular indications - page 24
  - Markers for dyslipidemia - page 29
  - Main types of dyslipidemia - page 31
- Epidemiology overview - page 33
  - Prevalence of dyslipidemia - page 33
  - Methodology - page 35
  - US - page 35
  - Japan - page 36
  - France - page 37
  - Germany - page 37
  - Italy - page 37
  - Spain - page 38
  - UK - page 39
- Lipitor: the gold standard in the treatment of dyslipidemia - page 39
- Associated pharmaceutical markets and indications - page 40
CHAPTER 3 GLOBAL MARKET OVERVIEW - page 45
- Key findings - page 45
- Global anti-dyslipidemic market analysis - page 46
  - Overview of global anti-dyslipidemic market - page 46
  - Initial uptake of Zetia versus Crestor - page 48
- Dyslipidemia pipeline overview - page 51
- Global market forecast - page 55
CHAPTER 4 STATINS - page 59
- Key findings - page 59
- Overview of the global statin market - page 60
  - Current statin indications - page 62
  - Statins market performance - page 63
- Statins market forecast - page 68
- Statin brand analysis - page 71
  - Lipitor (atorvastatin) - the gold-standard statin - page 71
  - Zocor (simvastatin) - HPS results may be too late - page 99
  - Pravachol (pravastatin) - strategies to slow the decline in sales - page 128
  - Mevalotin (pravastatin) - MEGA study holds the future - page 147
  - Lescol (fluvastatin) - to be replaced by pitavastatin? - page 154
  - Mevacor (lovastatin) - increasing erosion from genericization - page 168
  - Advicor (lovastatin/ER niacin) - the first combination statin - page 180
  - Crestor (rosuvastatin) - additional safety data required - page 192
  - Livalo (pitavastatin) - not so 'superstatin'? - page 215
CHAPTER 5 FIBRATES - page 225
- Key findings - page 225
- Overview of the global fibrate market - page 225
- Fibrates market forecast - page 228
- Fibrate brand analysis - page 231
  - Lipanthyl and TriCor (fenofibrate) - US generic threat - page 231
  - Cedur and Bezatol (bezafibrate) - triglyceride reductions not enough to ensure success - page 248
CHAPTER 6 'OTHER' ANTI-DYSLIPIDEMICS - page 250
- Key findings - page 250
- Overview of the global 'others' market - page 251
- 'Others' market forecast - page 255
- 'Others' brand analysis - page 257
  - Zetia (ezetimibe) - revenue protection for Zocor - page 257
  - WelChol (colesevelam) - difficult-to-treat patients hold the highest potential - page 275
  - Niaspan (niacin) - EU roll-out set to boost sales - page 288
  - Epadel (ethyl icosapentate) - confined to the Japanese market - page 304
  - Questran (cholestyramine) - alternative to fibrates in combination with statins - page 308
- Bibliography - page 310
  - Epidemiology - page 310
  - Clinical trial data - page 311
- Report methodology - page 318
  - Pricing sources - page 318
  - Disclaimer - page 319

List of Tables
Table 1: Future prevalence of dyslipidemia across the seven major markets, 2003-11 - page 10
Table 2: Current and future global sales for the leading anti-dyslipidemics ($m), 2002-11 - page 11
Table 3: Key changes to lipid levels between the NCEP II and NCEP III guidelines - page 31
Table 5: Mean number and volume of gadolimium-enhancing (Gd) lesions pre-treatment and post-treatment with simvastatin - page 42
Table 6: Global sales in the anti-dyslipidemic market by drug class, 2001-02 - page 46
Table 7: Key developmental compounds in the anti-dyslipidemic market, 2003 - page 54
Figure 5: Global anti-dyslipidemic market forecasts, 2003-11 - page 55
Table 8: Anti-dyslipidemic global sales forecasts, 2003-11 - page 58
Table 9: Statins fact file - page 61
Table 10: Summary of statin indications, 2003 - page 62
Table 11: Global sales of the leading branded statins, 2001-02 - page 64
Table 12: Comparison of global sales forecasts for the statins ($m), 2003-11 - page 70
Table 13: Lipitor: key facts - page 71
Table 14: Comparison of US drug prices for Lipitor and Zocor, 2003 - page 72
Table 15: Key clinical trials for Lipitor, 2003 - page 77
Table 16: Major Lipitor events, 2002-03 - page 78
Table 17: Endpoint results from ASCOT-LLA, 2003 - page 81
Table 18: Results of the REVERSAL trial - page 90
Table 19: Impacting factors on the revenues of Lipitor, 2003-11 - page 98
Table 20: Zocor: key facts - page 99
Table 21: Key clinical trials for Zocor - page 104
Table 22: Major Zocor events, 2002-03 - page 105
Table 23: Absolute effects of simvastatin allocation on five-year rates of first major vascular event among participants with diabetes, occlusive arterial disease, or both - page 112
Table 24: CHESS trial results - page 115
Table 25: Impacting factors on the revenues of Zocor, 2003-11 - page 126
Table 26: Pravachol: key facts - page 129
Table 27: Key clinical trials: Pravachol - page 131
Table 28: Major Pravachol events, 2002-03 - page 132
Table 29: PROSPER trial results - page 133
Table 30: Results of pilot trial evaluating atenolol versus nebivolol - page 136
Table 31: Results of pilot trial evaluating the combinations of atenolol/pravastatin and nebivolol/pravastatin - page 136
Table 32: Impacting factors on the revenues of Pravachol, 2003-11 - page 146
Table 33: Mevalotin: key facts - page 147
Table 34: Impacting factors on the revenues of Mevalotin, 2003-11 - page 153
Table 35: Lescol: key facts - page 154
Table 36: Lescol: key clinical trials - page 157
Table 37: Major Lescol events, 2002-03 - page 158
Table 38: Impacting factors on the revenues of Lescol, 2003-11 - page 167
Table 39: Mevacor: key facts - page 168
Table 40: Mevacor: key clinical trials - page 171
Table 41: Major Mevacor events, 2002-03 - page 172
Table 42: Attempted OTC switching in the US - page 176
Table 43: Impacting factors on the revenues of Mevacor, 2003-11 - page 179
Table 44: Advicor: key facts - page 180
Table 45: Advicor: key clinical trials - page 182
Table 46: Major Advicor events, 2002-03 - page 183
Table 47: ADVOCATE trial results - page 184
Table 48: Impacting factors on the revenues of Advicor, 2003-11 - page 191
Table 49: Crestor: key facts - page 192
Table 50: Crestor: key clinical trials - page 195
Table 51: Major Crestor events, 2002-03 - page 196
Table 52: Comparison of US drug prices for Lipitor and Crestor, 2003 - page 202
Table 53: GALAXY program summary - page 212
Table 54: Impacting factors on the revenues of Crestor, 2003-11 - page 214
Table 55: Livalo: key facts - page 215
Table 56: Key clinical trials: Livalo - page 217
Table 57: Major Livalo events, 2002-03 - page 218
Table 58: Impacting factors on the revenues of Livalo, 2003-11 - page 224
Table 59: Fibrates fact file - page 226
Table 60: Global sales of the leading branded fibrates, 2001-02 - page 226
Table 61: Triglyceride-lowering effects of statins - page 227
Figure 31: Fibrate market forecasts, 2003-11 - page 229
Table 62: Comparison of fibrate global sales forecasts ($m), 2003-11 - page 230
Table 63: Lipanthyl & TriCor: key facts - page 231
Table 64: Key clinical trials for fenofibrate - page 234
Table 65: Major Lipanthyl and TriCor events, 2002-03 - page 235
Table 66: Impacting factors on the revenues of TriCor, 2003-11 - page 246
Table 67: Impacting factors on the revenues of Lipanthyl, 2003-11 - page 247
Table 68: Bezafibrate: key facts - page 248
Table 69: Other anti-dyslipidemics fact file - page 251
Table 70: Global sales of the leading branded 'others', 2001-02 - page 252
Table 71: Cost of 'other' anti-dyslipidemics in the US - page 254
Figure 36: 'Other' anti-dyslipidemics market forecasts, 2003-11 - page 255
Table 72: Comparison of 'others' anti-dyslipidemics class global sales forecasts ($m), 2003-11 - page 256
Table 73: Zetia: key facts - page 257
Table 74: Zetia: key clinical trials - page 262
Table 75: Major Zetia events, 2002-03 - page 263
Table 76: Anti-dyslipidemic clinical trials assessing CRP reductions - page 266
Table 77: Results of the Add-On trial - page 270
Table 78: LDL cholesterol reduction obtained with ezetimibe alone versus simvastatin alone and ezetimibe plus simvastatin - page 270
Table 79: Impacting factors on the revenues of Zetia, 2003-11 - page 274
Table 80: WelChol: key facts - page 275
Table 81: WelChol: key clinical trials - page 278
Table 82: Major WelChol events, 2002-03 - page 279
Table 83: LDL cholesterol reductions with colesevelam alone and in combination versus ezetimibe alone and in combination - page 284
Table 84: Impacting factors on the revenues of WelChol, 2003-11 - page 287
Table 85: Niaspan: key facts - page 288
Table 86: Niaspan: key clinical trials - page 293
Table 87: Major Niaspan events, 2002-03 - page 294
Table 88: Roll-out of EU launches of Niaspan - page 301
Table 89: Impacting factors on the revenues of Niaspan, 2003-11 - page 303
Table 90: Epadel: key facts - page 304
Table 91: Use of combination therapy involving fish oil derivatives in Japan - page 305
Table 92: Questran: key facts - page 308

List of Figures
Figure 1: Scope and coverage of Datamonitor's 2003 dyslipidemia reports - page 4
Figure 2: Evolution of the anti-dyslipidemics market, 1987-2011 - page 12
Figure 3: Growth and market share of the anti-dyslipidemic drug classes, 2001-02 - page 47
Figure 4: Proportion of overall drug-treated dyslipidemia patients expected to be prescribed Zetia and Crestor by the end of their first year on the market in the seven major markets - page 50
Figure 6: Timeline for statin launches - page 60
Figure 7: Growth and class market share of the leading statins, 2001-02 - page 65
Figure 8: Global sales for the leading statins by quarter, 2002 - page 66
Figure 9: Availability of generic statins in the seven major markets in 2003 - page 67
Figure 10: Statin market forecasts, 2003-11 - page 68
Figure 11: SWOT analysis for Lipitor - page 94
Figure 12: Global sales forecasts for Lipitor, 2003-11 - page 97
Figure 13: Sales of Zocor versus Lipitor, Q1 2001 to Q4 2002 - page 101
Figure 14: SWOT analysis for Zocor - page 122
Figure 15: Global sales forecasts for Zocor, 2003-11 - page 125
Figure 16: SWOT analysis for Pravachol - page 142
Figure 17: Global sales forecasts for Pravachol, 2003-11 - page 145
Figure 18: SWOT analysis for Mevalotin - page 150
Figure 19: Global sales forecasts for Mevalotin, 2003-11 - page 152
Figure 20: Lescol SWOT analysis - page 164
Figure 21: Global sales forecasts for Lescol, 2003-11 - page 166
Figure 22: SWOT analysis for Mevacor - page 175
Figure 23: Global sales forecasts for Mevacor, 2003-11 - page 178
Figure 24: SWOT analysis: Advicor - page 188
Figure 25: Global sales forecasts for Advicor, 2003-11 - page 190
Figure 26: SWOT analysis for Crestor - page 207
Figure 27: Global sales forecasts for Crestor, 2003-11 - page 213
Figure 28: SWOT analysis for Livalo - page 220
Figure 29: Global sales forecasts for Livalo, 2003-11 - page 223
Figure 30: Growth and class market share of the leading fibrates, 2001-02 - page 228
Figure 32: SWOT analysis for Lipanthyl and TriCor - page 242
Figure 33: Global sales forecasts for TriCor, 2003-11 - page 245
Figure 34: Global sales forecasts for Lipanthyl, 2003-11 - page 247
Figure 35: Growth and class market share of the leading 'others', 2001-2002 - page 253
Figure 37: SWOT analysis for Zetia - page 269
Figure 38: Global sales forecasts for Zetia, 2003-11 - page 273
Figure 39: SWOT analysis for WelChol - page 282
Figure 40: Global sales forecasts for WelChol, 2003-11 - page 286
Figure 41: SWOT analysis for Niaspan - page 299
Figure 42: Global sales forecasts for Niaspan, 2003-11 - page 302
Figure 43: SWOT analysis for Epadel - page 307

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Commercial Perspectives: Anti-dyslipidemics - A tale of two launches

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