Reformulation Strategies

Introduction

Product lifecycle management (LCM) is an integral part of portfolio continuation and preservation. With R&D productivity stalling, and profit margins increasingly eroded by cost-containment initiatives, maximizing the return on investment (ROI) of in-line brands is a key objective for pharmaceutical companies.

Scope

• Overview of product reformulation new formulations and combination products; and how, when, and why manufacturers implement reformulation strategies
• Review of reformulations in cardiovascular, CNS, diabetes, and women's health
• Comparison of successful and less effective reformulation strategies recently implemented, and evaluation of future reformulation strategies
• In depth case study analysis, utilizing IMS data to examine launch timing, marketing and promotion, pricing strategies and satisfaction of unmet needs

Highlights

With reformulation forming an established, and ever growing part of product LCM, it is important that manufacturers fully evaluate the suitability and likely profitability of such a strategy before implementation, as failure to do so will significantly impact the uptake of the reformulation and ultimately reduce the drug's return on investment.

Reformulation is a widely employed LCM technique, of the 50 top manufacturers in 2005, 39% of total product launches from 20022005 were reformulations.

Recently, CNS and "alimentary and metabolic" therapies have been the most frequently targeted for reformulation; indicative of the large number of treated patient populations, high commercial value, and the highly competitive nature of the markets.

Reasons to Purchase

• Understand how companies employ reformulations throughout different stages of the parent product's lifecycle
• Assess the relative success and failures of reformulation strategies across both the US and EU markets
• Gain insight into how competitive differentiation, pricing, promotion and launch timing influence the success of reformulation strategies

• Chapter 1 Existing Reformulations
  • The importance of lifecycle management
  • Reformulation - a standard LCM strategy
  • Reformulation strategies
  • Why reformulate?
  • The key to a successful reformulation
  • Improved formulations
  • Reformulation strategies in the insomnia market
  • Combination products
  • Supergenerics
• Chapter 2 Reformulation Comparisons
  • Risperdal versus paliperidone
  • Risperdal Consta - a successful expand and grow strategy
  • Paliperidone IM - unlikely to sustain J&J's antipsychotic franchise
  • Summary
  • Concerta versus Symbyax
  • Concerta - a successful market grab strategy
  • Symbyax - an unsuccessful market/niche grab strategy
  • Summary
  • Detrol LA versus Luvox CR
  • Detrol LA - a successful switch/expansion strategy
  • Luvox CR - unlikely to succeed in the face of generics
  • Summary
  • Vytorin versus Caduet
  • Vytorin - success in the US and Germany
  • Caduet - failure in the US and EU
  • Summary
• Chapter 3 Reformulation Case Studies
  • Risperdal Consta - a successful expand and grow strategy
  • Why J&J refomulated Risperdal
  • Risperdal's life cycle management
  • Risperdal - low-dose tablets
  • Risperdal - oral solutions targeting pediatrics and geriatrics
  • Risperdal - M-Tab (dissolving tablet)
  • Risperdal Consta - the first and only long-term, injectable antipsychotic
  • Risperdal Consta represents an expand and grow strategy
  • Clear therapeutic advantage allows premium price, but is it too high?
  • Marketing drives patient compliance
  • Poor promotional spend in the US
  • Clinical trial data support therapeutic advantage and justify pricing of Consta
  • Paliperidone - generic defense, but will it succeed?
  • Paliperidone ER shows no clear therapeutic advantage over Risperdal
  • Paliperidone IM - differentiated from Consta, but is that enough to suceed?
  • Will J&J learn its lesson from Consta's pricing?
  • Few patients will switch to, or remain on, paliperidone once generic risperidone is available
  • Concerta - a successful market grab
  • Why J&J refomulated methylphenidate
  • Concerta represents a classic market grab strategy
  • Concerta has become the market leading ADHD drug
  • Clear therapeutic advantage allows premium price
  • Strong promotional spend drives Concerta uptake across the US and EU
  • Symbyax - a failed market/niche grab
  • Why Lilly developed Symbyax
  • Why is Symbyax failing?
  • Concerns over misuse
  • Cost-effective, but poor promotional spend
  • Lilly failed to demonstrate efficacy of Symbyax against a suitable comparator
  • Detrol LA - a successful switch strategy in the US, and expand and grow strategy in the UK and Germany
  • Why Pfizer refomulated Detrol
  • Expand and grow or switch and grow?
  • Switch and grow - US and Spain
  • Detrol LA priced equivalently to competitors in the US
  • Promotional spend drives uptake of Detrol LA
  • Expand and grow - UK, Germany and Italy
  • Daily dose of Detrol LA precied equivalently to Detrol IR
  • Lack of promotion in Italy impacts Detrol LA franchise at competitor launch
  • Why Solvay reformulated Luvox
  • Luvox CR is unlikely to make a significant impact on the anxiety market
  • Vytorin - a success in the US and Germany
  • Why Merck and Schering Plough reformulated Zocor and Zetia
  • Zocor (simvastatin)
  • Zetia (ezetimibe)
  • Vytorin - the first combination pill for hypercholesterolemia
  • US - switch and grow/generic defense, EU - expand and grow
  • Vytorin is priced as high as possible in the US and Germany, while still maintaining its cost-effectiveness
  • Significant increase in promotional spend for Vytorin in the first year of launch drives uptake in the US and Germany
  • Zetia's promotional spend was redirected to Vytorin after its launch in the US, UK and Germany
  • Caduet - an overcomplicated combination strategy
  • Why Pfizer developed Caduet
  • Caduet's 11 dose formulations complicate prescribing
  • Copaxone pre-filled syringe - a successful switch and grow strategy
  • Why Teva reformualted Copaxone
  • Copaxone's pricing strategies in the US and EU
  • Marketing and promotion drove switching to Copaxone PFS
• Chapter 4 Bibliography
  • Bibliography
  • Websites
  • Journal articles
• List of Tables
  • Table 1: Risperdal and paliperidone: key facts
  • Table 2: Concerta and Symbyax: key facts
  • Table 3: Detrol LA and Luvox CR: key facts
  • Table 4: Vytorin and Caduet: key facts
  • Table 5: Comparison of the successes of the Vytorin and Caduet franchises
  • Table 6: Risperdal: key facts
  • Table 7: Prices of different formulations of Risperdal, 2001-05, EU and US
  • Table 8: Paliperidone: key facts
  • Table 9: Comparison of paliperidone IM and Risperdal Consta
  • Table 10: Concerta: key facts
  • Table 11: Symbyax: key facts
  • Table 12: Detrol: key facts
  • Table 13: Revenue switch from Detrol to Detrol LA, 2001-05
  • Table 14: Luvox CR: key facts
  • Table 15: Marketed anxiety drugs approved for specific anxiety disorders, in the US, EU and Japan.
  • Table 16: Vytorin, Zocor and Zetia: key facts
  • Table 17: Revenue switch from Zocor and Zetia to Vytorin, 2001-05
  • Table 18: Caduet, Lipitor and Norvasc: key facts
  • Table 19: Proportion of patients to whom interviewed physicians would prescribe Caduet in its first year on the market, 2005
  • Table 20: Copaxone: key facts
  • Table 21: Revenue switch from Copaxone dry vial to pre-filled syringe, 2001-05
  • Table 22: Risperdal Consta market comparisons
  • Table 23: Concerta market comparisons
  • Table 24: Detrol LA market comparisons
  • Table 25: Vytorin market comparisons
  • Table 26: Copaxone market comparisons
• List of Figures
  • Figure 1: More than one-third of products launched in 2002-05 by the top 50 manufacturers were reformulations
  • Figure 2: Breakdown of US reformulations by therapy area, 2002-05
  • Figure 3: Reformulation strategies for the lifecycle of a drug
  • Figure 4: Four classes of strategic objectives for drug reformulation
  • Figure 5: A successful reformulation can provide a threefold opportunity to recoup development costs
  • Figure 6: Average lifecycle launch timings for four reformulation strategies in the US market
  • Figure 7: Comparison of Risperdal Consta and paliperidone IM
  • Figure 8: Comparison of Concerta and Symbyax
  • Figure 9: Comparison of Detrol LA and Luvox CR
  • Figure 10: Comparison of Vytorin and Caduet
  • Figure 11: Comparison of Consta franchise share and growth
  • Figure 12: Risperdal's reformulation history
  • Figure 13: US revenues from Risperdal formulations, 1999-2005
  • Figure 14: Risperdal M-Tab is priced significantly lower than Zyprexa Zydis, 2001-05
  • Figure 15: Switch from Risperdal (tablets and liquid) to Risperdal Consta, 2001-05
  • Figure 16: Expansion of the Risperdal franchise following the launch of Risperdal Consta, 2001-05
  • Figure 17: Annual costs of Risperdal Consta versus standard tablet antipsychotic formulations in the US and EU
  • Figure 18: The risperdalconsta.com and constantresources.com websites
  • Figure 19: Promotional spend for Risperdal products, 2003-05
  • Figure 20: Forecast revenues for J&J's schizophrenia franchise, 2006-15
  • Figure 21: Quarterly revenues and market share of Concerta, 2001-05
  • Figure 22: Switch to Concerta, 2001-05
  • Figure 23: Uptake of Concerta in the UK market, 2002-05
  • Figure 24: Comparison of Concerta launches and uptake
  • Figure 25: Price of Concerta (at launch) versus Ritalin in the US and EU
  • Figure 26: US and EU promotional spend of Concerta versus Ritalin
  • Figure 27: Symbyax, Zyprexa and Prozac revenues, 2001-05
  • Figure 28: Pricing of Symbyax versus Zyprexa, Prozac and generic fluoxetine, 2001-05
  • Figure 29: Promotional spend for Symbyax versus Zyprexa and Prozac
  • 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.
  • Figure 31: Comparison of Detrol LA launches and uptake
  • Figure 32: Quarterly growth rate of Detrol LA, 2001-05
  • Figure 33: Pricing of Detrol LA versus Detrol IR, 2001-05
  • Figure 34: Total promotional spend for Detrol and Detrol LA, 2003-05
  • Figure 35: Revenue switch from Detrol to Detrol LA, 2001-05
  • Figure 36: Quarterly growth rate of Detrol LA, 2001-05
  • Figure 37: Pricing of Detrol LA versus Detrol IR, 2001-05
  • Figure 38: Total promotional spend for Detrol and Detrol LA ,2003-05
  • Figure 39: Datamonitor forecast sales of Zocor, Zetia and Vytorin in the US and Germany to 2011
  • Figure 40: Quarterly growth rate of Vytorin, 2001-05
  • Figure 41: Pricing of Vytorin versus Zocor plus Zetia, 2001-05
  • Figure 42: Key efficacy studies play an important role in Vytorin product marketing
  • Figure 43: Promotional spend for Vytorin, Zocor and Zetia, 2003-05
  • Figure 44: Pricing of Caduet versus Lipitor plus Norvasc, 2001-05
  • Figure 45: US revenues and franchise share of Caduet after one year
  • Figure 46: US promotional spend for Lipitor, Caduet and Norvasc, 2003-05
  • Figure 47: Revenue share of Caduet doses, Q4 2005
  • Figure 48: Quarterly growth rate of Copaxone, 2001-05
  • Figure 49: Comparison of Copaxone franchise share and growth, US and EU
  • Figure 50: Price of Copaxone PFS versus the dry vial formulation
  • Figure 51: MSWatch - Copaxone's MS patient support website