スタチン系薬剤の補助治療薬市場の動向：ZetiaがZocorの収益を守る？

INTRODUCTION

Statins are undisputedly the gold standard in the treatment of dyslipidemia and more efficacious monotherapies are unlikely to be identified and developed in the near future. However, an important unmet need lies in the effective control of patients with complicated lipid profiles. Therefore, agents that can be used as adjuncts to statin therapy are being increasingly prescribed.

SCOPE OF THE REPORT

• Assess the market potential for non-statin anti-dyslipidemics offering a novel mechanism of action or additional benefits to statin monotherapy
• Examine the potential of Zetia as an adjunct to statin therapy by assessing its benefits over existing adjunctive therapies
• Understand existing constraints which may limit the uptake of Zetia and potential threats to the long-term success of the drug

REPORT HIGHLIGHTS

With statins unable to adequately control cholesterol in all patients, there remains a strong need for novel therapies that enhance the benefits of statins. In turn, Zetia is being firmly positioned as an adjunct to statin therapy, with the ability to enhance the LDL cholesterol lowering efficacy of these agents by 25%.

The combined use of a statin and Zetia as separate pills will have a negative impact on compliance and will increase the cost of lipid lowering therapy. However, the availability of a single pill combination of Zocor and Zetia may address certain of these issues.

The future sales potential of Zetia and its single pill formulation with Zocor may be threatened by third generation statins and developmental compounds with novel mechanisms of action that offer superior potency over marketed anti-dyslipidemics or have anti-atherosclerotic and anti-inflammatory benefits.

KEY REASONS TO BUY THIS REPORT

• Gain an independent view of the dynamics of the statin adjunct market and assess the future potential of these agents.
• Identify the most important unmet needs within the anti-dyslipidemic market for R&D prioritization.
• Understand the factors driving versus limiting the future of Zetia, thereby identifying the opportunities and threats within the adjunctive market.

Overview

Introduction

Scope

Report Highlights

Reasons to Purchase

DRIVERS AND TRENDS

Recent research suggests that around six out of ten patients with CHD receiving statin therapy were not at their LDL cholesterol target, as recommended by the NIH. This brief analyses the uptake of adjunctive therapies to statins, focusing on the future role of Zetia (ezetimibe) as an add-on therapy and as a single pill combination therapy with the first generation statin Zocor (simvastatin).

PATIENT POTENTIAL

Definition and segmentation of dyslipidemia combined with epidemiology data including:

• Estimated prevalence of hypercholesterolemia in the seven major markets from 2002 to 2010
• Prevalence of low HDL cholesterol broken down by age in the UK as an indicator of global trends

UPTAKE OF ADJUNCTIVE

Profiles of three existing adjunctive anti-dyslipidemics therapies, Niaspan, Advicor, and WelChol evaluating their patient and market potential.

• Drug Overview
• Clinical trial data
• Commercial potential

POTENTIAL FOR ZETIA

Examination of the commercial potential of Merck & Co./Schering-Plough' s cholesterol absorption inhibitor Zetia

• The historical development of the drug
• Existing clinical trial data for the use of the drug as a monotherapy and in combination with statins
• The potential drivers of Zetia' s commercial success, assessing the future role of the drug in the treatment of dyslipidemia
• Possible barriers to Zetia' s uptake

DATASETS

Table 1: Prevalence of hypercholesterolemia in the seven major markets (000s), 2002-2010

Table 2: Estimated prevalence of low HDL cholesterol (<40mg/dL) in the UK, 2003

Table 3: Cost comparison of Advicor single-pill combination versus Niaspan and generic lovastatin components

Table 4: Efficacy of Welchol as a monotherapy and in combination in reducing LDL cholesterol and triglyceride levels, and in increasing HDL cholesterol

Table 5: Clinical trial results for the use of Zetia as a monotherapy

Table 6: Clinical trial results obtained when adding ezetimibe to ongoing statin therapy in patients who had not met LDL cholesterol targets

Table 7: Clinical trial results obtained with the concurrent initiation of ezetimibe and statin therapy

Table 8: Comparison of Niaspan, Advicor and WeChol

Table 9: Factors that may drive of limit the uptake and potential of Zetia

Table 10: Number of fatal cases of rhabdomyolysis linked to statin usage in the US in 2001

Table 11: Key changes to lipid levels between the NCEP II and NCEP III

Table 12: Phase III trial results comparing rosuvastatin with atorvastatin

Table 13: Costs of statin monotherapy compared to Zetia/statin combination therapy

Table 14: Forecast sales of Zetia from 2003 to 2008 ($m)

Figure 1: Key factors in the market dynamics of Niaspan

Figure 2: Advicor: SWOT analysis

Figure 3: Key factors in the market dynamics of WelChol