Reformulation Strategies - Comparisons of Past and Future Reformulation Strategies

About the Strategic Intelligence Team 3
Scope of the report 4
Format of the report 4
CHAPTER 1 EXISTING REFORMULATIONS 13
The importance of lifecycle management 13
Reformulation - a standard LCM strategy 13
Reformulation strategies 16
Why reformulate? 17
The key to a successful reformulation 18
Improved formulations 20
Reformulation strategies in the insomnia market 20
Combination products 22
Supergenerics 23
CHAPTER 2 REFORMULATION COMPARISONS 25
Risperdal versus paliperidone 25
Risperdal Consta - a successful expand and grow strategy 25
Paliperidone IM - unlikely to sustain J&J's antipsychotic franchise 26
Summary 27
Concerta versus Symbyax 29
Concerta - a successful market grab strategy 29
Symbyax - an unsuccessful market/niche grab strategy 30
Summary 31
Detrol LA versus Luvox CR 33
Detrol LA - a successful switch/expansion strategy 33
Luvox CR - unlikely to succeed in the face of generics 34
Summary 35
Vytorin versus Caduet 37
Vytorin - success in the US and Germany 37
Caduet - failure in the US and EU 38
Summary 40
CHAPTER 3 REFORMULATION CASE STUDIES 43
Risperdal Consta - a successful expand and grow strategy 43
Why J&J refomulated Risperdal 45
Risperdal's life cycle management 46
Risperdal - low-dose tablets 46
Risperdal - oral solutions targeting pediatrics and geriatrics 47
Risperdal - M-Tab (dissolving tablet) 48
Risperdal Consta - the first and only long-term, injectable antipsychotic 49
Risperdal Consta represents an expand and grow strategy 50
Clear therapeutic advantage allows premium price, but is it too high? 52
Marketing drives patient compliance 54
Poor promotional spend in the US 55
Clinical trial data support therapeutic advantage and justify pricing of Consta 57
Paliperidone - generic defense, but will it succeed? 58
Paliperidone ER shows no clear therapeutic advantage over Risperdal 59
Paliperidone IM - differentiated from Consta, but is that enough to suceed? 60
Will J&J learn its lesson from Consta's pricing? 61
Few patients will switch to, or remain on, paliperidone once generic risperidone is available 61
Concerta - a successful market grab 64
Why J&J refomulated methylphenidate 65
Concerta represents a classic market grab strategy 65
Concerta has become the market leading ADHD drug 66
Clear therapeutic advantage allows premium price 70
Strong promotional spend drives Concerta uptake across the US and EU 72
Symbyax - a failed market/niche grab 73
Why Lilly developed Symbyax 74
Why is Symbyax failing? 75
Concerns over misuse 75
Cost-effective, but poor promotional spend 76
Lilly failed to demonstrate efficacy of Symbyax against a suitable comparator 78
Detrol LA - a successful switch strategy in the US, and expand and grow strategy in the UK and Germany 80
Why Pfizer refomulated Detrol 82
Expand and grow or switch and grow? 83
Switch and grow - US and Spain 83
Detrol LA priced equivalently to competitors in the US 85
Promotional spend drives uptake of Detrol LA 86
Expand and grow - UK, Germany and Italy 87
Daily dose of Detrol LA precied equivalently to Detrol IR 89
Lack of promotion in Italy impacts Detrol LA franchise at competitor launch 91
Why Solvay reformulated Luvox 93
Luvox CR is unlikely to make a significant impact on the anxiety market 93
Vytorin - a success in the US and Germany 96
Why Merck and Schering Plough reformulated Zocor and Zetia 97
Zocor (simvastatin) 97
Zetia (ezetimibe) 99
Vytorin - the first combination pill for hypercholesterolemia 99
US - switch and grow/generic defense, EU - expand and grow 101
Vytorin is priced as high as possible in the US and Germany, while still maintaining its cost-effectiveness 103
Significant increase in promotional spend for Vytorin in the first year of launch drives uptake in the US and Germany 106
Zetia's promotional spend was redirected to Vytorin after its launch in the US, UK and Germany 107
Caduet - an overcomplicated combination strategy 109
Why Pfizer developed Caduet 110
Caduet's 11 dose formulations complicate prescribing 114
Copaxone pre-filled syringe - a successful switch and grow strategy 116
Why Teva reformualted Copaxone 117
Copaxone's pricing strategies in the US and EU 122
Marketing and promotion drove switching to Copaxone PFS 124
CHAPTER 4 BIBLIOGRAPHY 125
Bibliography 125
Websites 125
Journal articles 126
List of Tables
Table 1: Risperdal and paliperidone: key facts 25
Table 2: Concerta and Symbyax: key facts 29
Table 3: Detrol LA and Luvox CR: key facts 33
Table 4: Vytorin and Caduet: key facts 37
Table 5: Comparison of the successes of the Vytorin and Caduet franchises 40
Table 6: Risperdal: key facts 43
Table 7: Prices of different formulations of Risperdal, 2001-05, EU and US 52
Table 8: Paliperidone: key facts 58
Table 9: Comparison of paliperidone IM and Risperdal Consta 60
Table 10: Concerta: key facts 64
Table 11: Symbyax: key facts 73
Table 12: Detrol: key facts 80
Table 13: Revenue switch from Detrol to Detrol LA, 2001-05 85
Table 14: Luvox CR: key facts 92
Table 15: Marketed anxiety drugs approved for specific anxiety disorders, in the US, EU and Japan. 94
Table 16: Vytorin, Zocor and Zetia: key facts 96
Table 17: Revenue switch from Zocor and Zetia to Vytorin, 2001-05 103
Table 18: Caduet, Lipitor and Norvasc: key facts 109
Table 19: Proportion of patients to whom interviewed physicians would prescribe Caduet in its first year on the market, 2005 114
Table 20: Copaxone: key facts 116
Table 21: Revenue switch from Copaxone dry vial to pre-filled syringe, 2001-05 119
Table 22: Risperdal Consta market comparisons 127
Table 23: Concerta market comparisons 128
Table 24: Detrol LA market comparisons 129
Table 25: Vytorin market comparisons 130
Table 26: Copaxone market comparisons 130
List of Figures
Figure 1: More than one-third of products launched in 2002-05 by the top 50 manufacturers were reformulations 14
Figure 2: Breakdown of US reformulations by therapy area, 2002-05 15
Figure 3: Reformulation strategies for the lifecycle of a drug 16
Figure 4: Four classes of strategic objectives for drug reformulation 17
Figure 5: A successful reformulation can provide a threefold opportunity to recoup development costs 18
Figure 6: Average lifecycle launch timings for four reformulation strategies in the US market 19
Figure 7: Comparison of Risperdal Consta and paliperidone IM 28
Figure 8: Comparison of Concerta and Symbyax 32
Figure 9: Comparison of Detrol LA and Luvox CR 36
Figure 10: Comparison of Vytorin and Caduet 42
Figure 11: Comparison of Consta franchise share and growth 45
Figure 12: Risperdal's reformulation history 46
Figure 13: US revenues from Risperdal formulations, 1999-2005 47
Figure 14: Risperdal M-Tab is priced significantly lower than Zyprexa Zydis, 2001-05 48
Figure 15: Switch from Risperdal (tablets and liquid) to Risperdal Consta, 2001-05 50
Figure 16: Expansion of the Risperdal franchise following the launch of Risperdal Consta, 2001-05 51
Figure 17: Annual costs of Risperdal Consta versus standard tablet antipsychotic formulations in the US and EU 53
Figure 18: The risperdalconsta.com and constantresources.com websites 55
Figure 19: Promotional spend for Risperdal products, 2003-05 56
Figure 20: Forecast revenues for J&J's schizophrenia franchise, 2006-15 63
Figure 21: Quarterly revenues and market share of Concerta, 2001-05 67
Figure 22: Switch to Concerta, 2001-05 68
Figure 23: Uptake of Concerta in the UK market, 2002-05 69
Figure 24: Comparison of Concerta launches and uptake 70
Figure 25: Price of Concerta (at launch) versus Ritalin in the US and EU 71
Figure 26: US and EU promotional spend of Concerta versus Ritalin 72
Figure 27: Symbyax, Zyprexa and Prozac revenues, 2001-05 75
Figure 28: Pricing of Symbyax versus Zyprexa, Prozac and generic fluoxetine, 2001-05 76
Figure 29: Promotional spend for Symbyax versus Zyprexa and Prozac 77
Figure 30: Detrol LA became the leading once-daily OAB treatment within a year, and the market leading therapy in the US and UK after four and 10 quarters, respectively. 81
Figure 31: Comparison of Detrol LA launches and uptake 82
Figure 32: Quarterly growth rate of Detrol LA, 2001-05 84
Figure 33: Pricing of Detrol LA versus Detrol IR, 2001-05 86
Figure 34: Total promotional spend for Detrol and Detrol LA, 2003-05 87
Figure 35: Revenue switch from Detrol to Detrol LA, 2001-05 88
Figure 36: Quarterly growth rate of Detrol LA, 2001-05 89
Figure 37: Pricing of Detrol LA versus Detrol IR, 2001-05 90
Figure 38: Total promotional spend for Detrol and Detrol LA ,2003-05 91
Figure 39: Datamonitor forecast sales of Zocor, Zetia and Vytorin in the US and Germany to 2011 100
Figure 40: Quarterly growth rate of Vytorin, 2001-05 102
Figure 41: Pricing of Vytorin versus Zocor plus Zetia, 2001-05 105
Figure 42: Key efficacy studies play an important role in Vytorin product marketing 106
Figure 43: Promotional spend for Vytorin, Zocor and Zetia, 2003-05 108
Figure 44: Pricing of Caduet versus Lipitor plus Norvasc, 2001-05 111
Figure 45: US revenues and franchise share of Caduet after one year 112
Figure 46: US promotional spend for Lipitor, Caduet and Norvasc, 2003-05 113
Figure 47: Revenue share of Caduet doses, Q4 2005 115
Figure 48: Quarterly growth rate of Copaxone, 2001-05 120
Figure 49: Comparison of Copaxone franchise share and growth, US and EU 121
Figure 50: Price of Copaxone PFS versus the dry vial formulation 123
Figure 51: MSWatch - Copaxone's MS patient support website 124