Market Report Source

Overview

Introduction

Commercial Insight: Antidyslipidemics explores current trends and key future issues in the management of dyslipidemia and the effects of generic competition and healthcare reforms on the main drug classes in this market. The growth potential of the leading classes is discussed, and case studies are used to highlight possible strategies to maximize future growth for lipid management franchises.

Scope

*Event-driven sales forecasts, for the period 2006-15, for the US, Japan, France, Germany, Italy, Spain and the UK, along with a global overview *Discussion of individual products in five main classes, focusing mainly on the statins, fibrates and other antidyslipidemics (e.g. Zetia, Niaspan) *Profiles of the country and market specific issues which will impact future sales in the market including generic erosion and new product launches *Commercial impact case studies on R&D innovation and the impact of generic erosion

Highlights

2006 is likely to mark an inflexion point in the sales value of the statin class across the seven major markets (7MM). Key drivers of this include patent expiries to Zocor and Pravachol in the US, with a predicted $8 billion expected to be wiped off the value of the branded statin monotherapy market between 2006-11 as a result.

Strategies designed to blunt the impact of generic erosion on lipid management franchises include the development and commercialization of novel products. With further advances in LDL-C lowering efficacy unlikely, current research is focused on developing better tolerated and more effective HDL-C targeted therapies.

A growing in-licensing and acquisition trend has surfaced in lipid management and antiatherosclerotic R&D. As in-house productivity falls, big pharma has spent billions on shoring up product pipelines, focusing particular on novel HDL-C targeted therapies, which Datamonitor believes is evolving into the new battleground in lipid management.

Reasons to Purchase

*Gain insight into the antidyslipidemics market via up-to-date thought-leader opinions and gold-standard IMS Health sales data *Assess the potential impact of clinical trial results, generic erosion and new product launches on the antidyslipidemics market *Access independent, event-driven forecasts for key antidyslipidemic products and classes across the seven major markets

Table of Contents

ABOUT DATAMONITOR HEALTHCARE

ADDENDUM

Pfizer provides update on plans for torcetrapib

CHAPTER 1 EXECUTIVE SUMMARY

Objective of the analysis

Datamonitor insight into the antidyslipidemics market

Summary of key milestones in the antidyslipidemics market

CHAPTER 2 MARKET DEFINITION AND OVERVIEW

Sales figures definition for this report

Market definition for this report

Current market situation

Strategic scoping and focus

CHAPTER 3 COUNTRY MARKET ASSESSMENTS

Global: market level assessment, opportunities and threats

Market level assessment

Opportunities

Patient numbers set to remain flat over the forecast period, but sheer numbers provide a sufficient patient pool

Decreased rates of diagnosis should provide the catalyst for better physician and patient education …

... While increasing treatment rates across 7MM could drive sales

Big pharma cannot ignore the emerging markets of India and China

New products should drive growth, but innovation comes at a price

Growing awareness of the metabolic syndrome

Threats

Patent expiry and generic erosion

Parallel trade

The growing problem of counterfeited drugs

The impact of poor public perception of the pharmaceutical industry

US: market level assessment, opportunities and threats

Market level assessment

Opportunities

Leveraging the NCEP ATP III guidelines

Direct-to-consumer (DTC) advertising is legal in the US and has been shown to influence patient prescription choice and increase diagnosis rates

Obesity becomes a super-sized epidemic in the US

Threats

High profile generic entrants into the statin class could slow growth

Medicare and Medicaid

Drug importation

Pricing and reimbursement issues

Japan: market level assessment, opportunities and threats

Market level assessment

Opportunities

Ageing population

An underdeveloped generics market slows brand erosion

Threats

Despite being underdeveloped, generics are expected to evolve into a significant player in the Japanese healthcare market in the future

Biannual price cuts still threaten market growth

Complex regulatory process

New healthcare reforms under debate

France: market level assessment, opportunities and threats

Market level assessment

Opportunities

Innovation encouraged in the pharmaceutical industry

Threats

Continuation of cost-control measures

Formulary access

Take off of generic sector

Germany: market level assessment, opportunities and threats

Market level assessment

Opportunities

Pricing freedom which supports innovation

Threats

Cost-containment measures in Germany have led to a healthy generics market

Italy: market level assessment, opportunities and threats

Market level assessment

Opportunities

Single agency holds regulatory authority

Negligible impact of generics is set to continue

Threats

Ongoing cost-containment measures

Stringent reference pricing system

Restructured reimbursement categories

Intellectual property to conform with rest of EU

Spain: market level assessment, opportunities and threats

Market level assessment

Opportunities

Underdeveloped generics market

Threats

Complex pricing system

Increased scrutiny of new drugs

Compulsory patient co-payments

UK: market level assessment, opportunities and threats

Market level assessment

Opportunities

Attractiveness of market

Supplementary and expanded prescribing powers

Taking the GMS contract to the next level

Increasing privatization has the potential to fuel use of higher-priced pharmaceuticals

Threats

Falling foul of the ABPI, the UK’s pharma watchdog

The National Institute of Clinical Excellence (NICE)

PPRS implements periodic price cuts

Cost-containment measures encourage continued high use of generics

Summary of environmental issues affecting the antidyslipidemics market size

CHAPTER 4 FORECAST ANALYSIS

Key events

Increased patient potential increases market size

New product launches

Atorvastatin plus torcetrapib

JTT-705

MK-0524A and MK-0524B

Simcor (KS-01-019; simvastatin plus extended release niacin)

FM-VP4 (disodium ascorbyl phytosanyl phosphate)

Major clinical trials

AIM-HIGH (Atherothrombosis intervention in metabolic syndrome with low HDL-C/high triglyceride and impact on global health outcomes)

COMPELL (comparative effects on lipid levels of Niaspan and statins versus other lipid therapies)

EXPLORER (examination of potential lipid modifying effects of rosuvastatin in combination with ezetimibe versus rosuvastatin alone)

VYVeR (Vytorin versus rosuvastatin)

GALAXY – AstraZeneca’s landmark program for Crestor (rosuvastatin)

HPS-2 THRIVE (treatment of HDL to reduce the incidence of vascular events)

IMPROVE IT (Improved reduction of outcomes: Vytorin efficacy international trial)

Additional indications

AstraZeneca will seek a plaque reversal indication for Crestor, but only when METEOR is completed in 2007

Pfizer obtains stroke prevention indication for Lipitor via SPARCL, but little impact on Lipitor sales is expected as a result of other, more effective, stroke prevention therapies being available

Schering-Plough/Merck & Co. receive FDA approval to promote Zetia use in combination with fenofibrate, but little impact on Zetia sales expected

Patent expiries

Effect of Medicare Modernization Act in the US

Biennial price cuts in Japan

Generic erosion assumptions

Data definitions, limitations and assumptions

Standard units

Japanese market data

Derivation of sales forecasts and pricing trends

Forecasts

Forecast methodology

CHAPTER 5 COMMERCIAL IMPACT AND LIFECYCLE MANAGEMENT: CASE STUDIES

Introduction

Case studies

Torcetrapib: an assessment of Pfizer’s position and key questions that will need to be answered before approval and launch

Introduction

HDL as a therapeutic target

Raising HDL the torcetrapib way

Pfizer’s Phase III program for torcetrapib/atorvastatin – $800 million and counting

All eyes will be on plaque regression data

Will plaque regression have an impact on mortality?

Is torcetrapib’s pro-hypertensive side effect anything to worry about?

What is the competition and how much will they affect torcetrapib’s commercial success?

In an era of increased sensitivity to price, what will the combination’s price be?

What is the patient potential for torcetrapib?

Summary

The patent expiries of Pravachol and Zocor in the US market: potential impacts, likely scenarios, desperate measures?

Overview

The antidyslipidemic patent landscape in the US

The impact of Zocor’s patent expiry – branded share is expected to erode considerably, and quickly

The impact on Lipitor – will brand loyalty and marketing muscle be enough to maintain market share for Pfizer?

The impact on the statins market – dynamics will swing in favor of generics

Could the statins be a case study for future therapeutic substitution?

APPENDIX A – MARKET DATA AND MAJOR BRAND FACTS

Summary of market data

Segmentation by country

Segmentation by drug class

Major brand facts

Statin market data

Lipitor

Zocor

Pravachol

Crestor

Vytorin

Fibrate market data

Tricor

Other antidyslipidemics market data

Zetia

APPENDIX B – MARKET FORECAST DATA

US

Japan

France

Germany

Italy

Spain

UK

M5EU

Global

APPENDIX C

Bibliography

References

Report methodology

About Datamonitor

About Datamonitor Healthcare

Datamonitor Healthcare’s therapy area capabilities

About the Cardiovascular analysis team

Key therapy team members

Dr Allison Fleetwood, Director, Cardiovascular, Diabetes and Women’s Health

Disclaimer

List of Tables

Table 1: 7MM sales of the antidyslipidemic drug classes, 2005

Table 2: Seven major market sales and market share of the 10 top-selling antidyslipidemics, 2005

Table 3: Prevalence of dyslipidemia (000s) in the seven major pharmaceutical markets, 2005-15 (totals are rounded to nearest thousand)

Table 4: US antidyslipidemic sales, 2005

Table 5: Prevalence of obesity in the seven major markets by age (000s), 2003 (all totals have been rounded where applicable)

Table 6: Japan antidyslipidemic sales, 2005

Table 7: An example of the savings to be realized by using generic drugs

Table 8: France antidyslipidemic sales, 2005

Table 9: Germany antidyslipidemic sales, 2005

Table 10: Italy antidyslipidemic sales, 2005

Table 11: Spain antidyslipidemic sales, 2005

Table 12: UK antidyslipidemic sales, 2005

Table 13: The ten clinical areas of the Quality Outcome Framework, as outlined in the GMS contract, 2005

Table 14: Summary of macro-environmental issues affecting the antidyslipidemics market, 2006

Table 15: Prevalence of dyslipidemia (000s) in the seven major pharmaceutical markets, 2005-15 (totals are rounded to nearest thousand)

Table 16: Efficacy of torcetrapib vs. JTT-705; HDL-C and LDL-C measure

Table 17: COMPELL study results: mean percent change from baseline at study end (week 12)

Table 18: Efficacy of Crestor plus Zetia; HDL-C and LDL-C measure

Table 19: Key efficacy results from Vytorin versus simvastatin

Table 20: Key efficacy results from Vytorin versus atorvastatin (VYVA)

Table 21: Key efficacy results from Vytorin versus rosuvastatin (VYVeR)

Table 22: Patent expiry information for key antidyslipidemic brands, 2006

Table 23: Selected statin outcome trials and the risk reduction

Table 24: Meta-analysis of standard versus intensive lipid lowering therapy in four large statin outcome trials (n=27,548); LDL-C reduction data

Table 25: Meta-analysis of standard versus intensive lipid lowering therapy in four large statin outcome trials (n=27,548); odds reduction and event data

Table 26: Phase II trial results for the atorvastatin + torcetrapib combination

Table 27: Mean percent increase in HDL-C

Table 28: Mean percentage decrease in LDL-C

Table 29: Patient discontinuation results

Table 30: Summary of torcetrapib’s late-stage clinical development, 2006

Table 31: Examples of HDL-elevating strategies, both marketed and in development, that have the potential to compete with torcetrapib, 2006

Table 32: The US statin monotherapy* market, 2005

Table 33: Patent position for each of the statins in the US

Table 34: Lipitor: key facts

Table 35: Zocor: key facts

Table 36: Pravachol: key facts

Table 37: Crestor: key facts

Table 38: Vytorin: key facts

Table 39: Tricor: key facts

Table 40: Zetia: key facts

Table 41: US antidyslpidemic sales forecasts ($m; 2005 figures are actuals)

Table 42: Japan antidyslpidemic sales forecasts ($m; 2005 figures are actuals)

Table 43: France antidyslpidemic sales forecasts ($m; 2005 figures are actuals)

Table 44: Germany antidyslpidemic sales forecasts ($m; 2005 figures are actuals)

Table 45: France antidyslpidemic sales forecasts ($m; 2005 figures are actuals)

Table 46: Spain antidyslpidemic sales forecasts ($m; 2005 figures are actuals)

Table 47: UK antidyslpidemic sales forecasts ($m; 2005 figures are actuals)

Table 48: M5EU antidyslpidemic sales forecasts ($m; 2005 figures are actuals)

Table 49: Global antidyslpidemic sales forecasts ($m; 2005 figures are actuals)

List of Figures

Figure 1: Key milestones expected to have an impact on the 7MM antidyslipidemics market, 2006 to 2015

Figure 2: 7MM pharmaceutical sales, 2004-05

Figure 3: Comparative antidyslipidemic market share information for 7MM in terms of sales value and sales volume, split by country, 2005

Figure 4: The prevalence of obesity is set to continue to rise in the US in the coming decade

Figure 5: Datamonitor research has shown that dyslipidemia diagnosis rates have fallen between 2003 and 2005

Figure 6: Datamonitor research has shown that dyslipidemia treatment rates have risen between 2003 and 2005

Figure 7: Age trends for mean TSC, LDL-C, and HDL-C in Chinese females (dashed lines) and Chinese males (solid lines).

Figure 8: Summary of potential licensing revenues due to Atherogenics in respect of out-licensing of AGI-1067 to AstraZeneca

Figure 9: Generalized distribution chain for parallel traded pharmaceutical products

Figure 10: AstraZeneca’s Crestor (rosuvastatin) and Abbott’s Tricor (fenofibrate) features on Public Citizen’s http://www.worstpills.org website

Figure 11: The growing prevalence of obesity in the US

Figure 12: Pravachol only accounts for 11% of US statin monotherapy sales value ($m) and 8.6% of sales volume (SUm)

Figure 13: Key pressures facing drug developers

Figure 14: The Japanese generic market is underdeveloped because of a number of factors

Figure 15: The various elements of the GALAXY program

Figure 16: HDL-C metabolism and the role of CETP

Figure 17: HDL-C levels in male and female residents of the USA

Figure 18: Likely scenarios for switching from Zocor to generic simvastatin, and the effect of generic atorvastatin from 2011 on generic simvastatin sales

Figure 19: Between 2006 and 2011, the value of the branded US statin monotherapy market is expected to fall by $8 billion (50%) due to generic incursion on branded statin revenues

Figure 20: Segmentation of the antidyslipidemics market by country

Figure 21: Segmentation of the antidyslipidemics market by drug class 160