Forecast Insight: Multiple Sclerosis - Tysabri to prevail despite safety setbacks

Published by: Datamonitor

Published: Aug. 20, 2008 - 127 Pages

Table of Contents

ABOUT DATAMONITOR HEALTHCARE

About the Central Nervous System (CNS) pharmaceutical analysis team

CHAPTER 1 EXECUTIVE SUMMARY

Strategic scoping and focus

Datamonitor insight into the disease market

Contributing experts

Related reports

CHAPTER 2 MARKET DEFINITION AND OVERVIEW

Market definition for this report

Current seven major market assessment

The seven major multiple sclerosis market grew to over $5.3 billion in 2007

US shows lowest yearly growth yet still accounts for over 65% of the seven major markets for multiple sclerosis in 2007

Despite strong growth over 2007 the UK remains a small market

Rest of the World snapshot

Rest of the world multiple sclerosis market is growing faster than the seven major markets

Canada is by far the largest emerging multiple sclerosis market

No one product dominates the multiple sclerosis market in the rest of the world

Future seven major market assessment

Comparison with previous forecast

Similar market dynamics between the two forecasts with Tysabri's upgrade the most significant change

Top-line events driving future market dynamics

Three distinct phases will determine the multiple sclerosis market dynamics over the next 10 years

Forecast data tables

CHAPTER 3 BRAND DYNAMICS

Multiple sclerosis competitive landscape

Current brand dynamics

Biogen Idec's Avonex remains top-selling multiple sclerosis therapy in 2007

Copaxone overtakes Avonex in the US in 2007 while Rebif leads in Europe

Avonex and Copaxone are more reliant on US sales

Tysabri became the sixth available multiple sclerosis therapy following its relaunch in 2006

Future market forecast by brand

Despite recent safety fears Tysabri is predicted to become a leading brand in the multiple sclerosis market

Novartis's FTY720 expected to achieve the greatest sales of all current late-stage pipeline products

Marketed brands overview

Avonex (interferon beta-1a, Biogen Idec and Genzyme)

Overview

Ongoing post-marketing studies unlikely to make much of an impact on Avonex prescriptions

Avonex sales to decline as Tysabri cannibalizes sales and biosimilar versions and pipeline products come to market

Copaxone (glatiramer acetate, Teva and Sanofi-Aventis)

Overview

Postmarketing trial results provide mixed market opportunities for Copaxone

Copaxone sales to decline following patent expiry and increased market competition from pipeline products

Rebif (interferon beta-1a, Merck Serono and Pfizer)

Overview

Merck Serono looks for Rebif to succeed through improved tolerability and early intervention

Increased market competition to offset positive near-term growth

Betaseron (interferon beta-1b, Bayer Schering)

Overview

Post-marketing studies provide mixed outlook for future Betaseron market growth

Limited future growth for Betaseron as Extavia cannibalizes sales and biosimilar versions and multiple pipeline products come to market

Tysabri (natalizumab, Biogen Idec and Elan)

Overview

Two new confirmed cases of PML rocks initially strong 2008 Tysabri uptake

Tysabri's sales forecast upgraded, however long-term growth hinges on the incidence and management of new PML cases

Novantrone (mitoxantrone)

Reintroduction of Tysabri pushes Novantrone further down the prescribing pathway

Key late-stage pipeline overview

Extavia (interferon beta-1b, Novartis)

Novartis's Extavia added to forecast update

US Extavia approval expected to follow May 2008 European approval

Establishing a presence in the multiple sclerosis market is of more importance to Novartis than multi-million dollar Extavia sales

Mylinax (oral cladribine, Merck Serono and Teva)

Overview

Phase III study fully enrolled with results expected for early 2009

Fast Track status provides oral cladribine with opportunity to become the first oral disease-modifier to market

Oral cladribine forecasts downgraded as price is reduced to account for anticipated add-on positioning

Fingolimod (FTY720, Novartis and Mitsubishi Tanabe Pharma)

Overview

Primary Phase III studies fully enrolled with results expected for late 2009

Three-year Phase II results show continued low relapse and disease activity

Long-term safety of FTY720 remains a concern

Extavia launch crucial for Novartis to build a presence in the multiple sclerosis market prior to FTY720 launch

Forecast update sees FTY720 uptake plateau off earlier due to greater pipeline competition

Panaclar (BG-12, Biogen idec)

Overview

Phase III studies continue to recruit patients

Thrice-daily dosing and anticipated positioning as add-on therapy results in assumed price reduction and downgraded forecast for BG-12

Dirucotide (MBP8298, BioMS Medical and Eli Lilly)

Overview

MBP8298 could become the only approved treatment for true secondary-progressive multiple sclerosis

Datamonitor successfully predicted Big Pharma collaboration in previous forecast

Forecast upgraded due to increased annual price point and greater recognition of the secondary-progressive market sector potential

Laquinimod (Active Biotech and Teva)

Overview

First Phase III study initiated in September 2007

Phase III efficacy profile will dictate laquinimod's positioning as either monotherapy or add-on therapy

Laquinimod overtakes teriflunomide to become the penultimate pipeline oral disease modifier to launch in forecast period

Campath (alemtuzumab, Genzyme and Bayer Schering)

Alemtuzumab added to forecast update

Phase II data show superior efficacy compared to Rebif

Phase III alemtuzumab clinical program initiated in second half of 2007

Alemtuzumab's greatest potential in multiple sclerosis is when given early

Side-effect issues will limit alemtuzumab's return from multiple sclerosis

Alemtuzumab's yearly price will bode well for reimbursement status but will prevent Genzyme and Bayer generating large revenues in multiple sclerosis

Teriflunomide (Sanofi-Aventis)

Overview

Phase III program broadened to offset slow initial enrollment

Teriflunomide forecast downgraded as regulatory submission now anticipated for 2012 and market positioning as add-on appears likely outcome

Anti-CD20 monoclonal antibody (Genentech and Biogen idec)

Rituxan not forecast to launch for multiple sclerosis

Ocrelizumab replaces Rituxan in Datamonitor's multiple sclerosis forecast

Biosimilar interferon beta

Despite lower costs brand loyalty may limit reward of biosimilars in multiple sclerosis

Biferonex (interferon beta-1a)

Unforecasted multiple sclerosis pipeline candidates

BIBLIOGRAPHY

Journal papers and broker reports

Websites

Datamonitor reports

APPENDIX A - MARKET ASSUMPTIONS

New product launches

Patent expiries

Data definitions, limitations and assumptions

Standard units

Japanese market data

Derivation of sales forecasts and pricing trends

Forecast methodology

APPENDIX B

Contributing experts

Report methodology

About Datamonitor

About Datamonitor Healthcare

About the central nervous system analysis team

Disclaimer

List of Tables

Table 1: Comparison of branded drug sales ($m) for multiple sclerosis in the seven major markets (7MM) and the Rest of the World (RoW), 2004-07

Table 2: Overview of the top three small and emerging markets for the leading five multiple sclerosis brands by sales ($m), 2007

Table 3: Multiple sclerosis-specific sales forecasts for the seven major markets ($m), 2007-2017

Table 4: Leading branded drug sales ($m) for multiple sclerosis in the seven major markets, 2004-07

Table 5: Branded drug sales ($m) for multiple sclerosis disease-modifying drugs in the seven major markets, 2007-2017

Table 6: Forecast for key products in late-stage R&D pipeline for multiple sclerosis, 2008

Table 7: Avonex: key facts, 2008

Table 8: Avonex (interferon-beta 1a) sales ($m) in each of the seven major markets, 2004-07

Table 9: Sales forecast ($m) for Avonex in the seven major markets, 2007-17

Table 10: Copaxone: key facts, 2008

Table 11: Copaxone (glatiramer acetate) sales ($m) in each of the seven major markets, 2004-07

Table 12: Sales forecast ($m) for Copaxone in the seven major markets, 2007-17

Table 13: Rebif: key facts, 2008

Table 14: Rebif (interferon-beta 1a) sales ($m) in each of the seven major markets, 2004-07

Table 15: Sales forecast ($m) for Rebif in the seven major markets, 2007-17

Table 16: Betaseron: key facts, 2008

Table 17: Betaseron (interferon-beta 1b) sales ($m) in each of the seven major markets, 2004-07

Table 18: Sales forecast ($m) for Betaseron in the seven major markets, 2007-17

Table 19: Tysabri: key facts, 2008

Table 20: Tysabri (natalizumab) sales ($m) in each of the seven major markets, 2004-07

Table 21: Sales forecast ($m) for Tysabri in the seven major markets, 2007-17

Table 22: Novantrone: key facts, 2008

Table 23: Sales forecast ($m) for Extavia in the seven major markets, 2007-17

Table 24: Key ongoing oral cladribine multiple sclerosis studies, 2008

Table 25: Multiple sclerosis-specific sales forecast ($m) for oral cladribine (Mylinax) in the seven major markets, 2007-17

Table 26: Key ongoing FTY720 multiple sclerosis studies, 2008

Table 27: Multiple sclerosis-specific sales forecast ($m) for FTY720 (fingolimod) in the seven major markets, 2007-17

Table 28: Key ongoing BG-12 multiple sclerosis studies, 2008

Table 29: Multiple sclerosis-specific sales forecast ($m) for BG-12 (Panaclar) in the seven major markets, 2007-17

Table 30: Key ongoing MBP8298 multiple sclerosis studies, 2008

Table 31: Multiple sclerosis-specific sales forecast ($m) for MBP8298 (Dirucotide) in the seven major markets, 2007-17

Table 32: Key ongoing laquinimod multiple sclerosis studies, 2008

Table 33: Multiple sclerosis-specific sales forecast ($m) for laquinimod in the seven major markets, 2007-17

Table 34: Phase II 2-year data for alemtuzumab in multiple sclerosis

Table 35: Key ongoing alemtuzumab multiple sclerosis studies, 2008

Table 36: Multiple sclerosis-specific sales forecast ($m) for alemtuzumab (Campath) in the seven major markets, 2007-17

Table 37: Key ongoing teriflunomide multiple sclerosis studies, 2008

Table 38: Multiple sclerosis-specific sales forecast ($m) for teriflunomide in the seven major markets, 2007-17

Table 39: Multiple sclerosis-specific sales forecast ($m) for ocrelizumab in the seven major markets, 2007-17

Table 40: Sales forecast ($m) for interferon beta biosimilars in the seven major markets, 2007-17

Table 41: Unforecasted developmental disease-modifying pipeline drugs in Phase II or higher development for multiple sclerosis, 2008

Table 42: Datamonitor's estimated launch dates for multiple sclerosis products in the US, Japan and 5EU, 2008-2017

Table 43: Anticipated patent expiry dates for multiple sclerosis brands in the US, Japan and 5EU, 2008-2017

List of Figures

Figure 1: Multiple sclerosis market value ($ billion) in the US, 5EU and Japan, 2004-07

Figure 2: Multiple sclerosis market sales volume (SU million) in the US, 5EU and Japan, 2004-07

Figure 3: Multiple sclerosis-specific sales by country in the seven major markets, 2006-07

Figure 4: Multiple sclerosis market sales value ($) and volume (SUs) in the rest of the world, 2004-07

Figure 5: Rest of the world versus the US and Japan and 5EU market sales ($m) split in the multiple sclerosis market, 2007

Figure 6: Multiple sclerosis market sales value ($m) in the 10 highest value emerging markets, 2004-07

Figure 7: Comparison of Datamonitor's updated multiple sclerosis market forecast to 2017 with the previous market forecast to 2016

Figure 8: Forecast multiple sclerosis market value ($m) in the seven major markets, 2008-2017

Figure 9: Impact of key events on the multiple sclerosis market, 2008-2017

Figure 10: Multiple sclerosis market position of the leading four disease-modifying therapies across the seven major markets, 2007

Figure 11: Proportion of the leading five multiple sclerosis brand sales value originating from the US, 5EU/Japan combined, and the rest of the world, 2007

Figure 12: Timeline: launch dates of disease-modifying therapies for the treatment of multiple sclerosis, 1993-2006

Figure 13: Multiple sclerosis-specific sales ($m) forecast for Avonex in the seven major markets, 2007-2017

Figure 14: Multiple sclerosis-specific sales ($m) forecast for Copaxone in the seven major markets, 2007-2017

Figure 15: REFLEX study and positioning in multiple sclerosis treatment

Figure 16: Multiple sclerosis-specific sales ($m) forecast for Rebif in the seven major markets, 2007-2017

Figure 17: Multiple sclerosis-specific sales ($m) forecast for Betaseron in the seven major markets, 2007-2017

Figure 18: Datamonitor's 2007 and updated sales ($m) forecast for Biogen Idec and Elan's Tysabri in the seven major markets, 2007-2017

Figure 19: Comparative sales forecast ($m) of the nine pipeline products launched during Datamonitor's 10-year multiple sclerosis market forecast, 2008-17

Figure 20: Multiple sclerosis-specific sales ($m) forecast for Extavia in the seven major markets, 2007-2017

Figure 21: Datamonitor's 2007 and updated sales ($m) forecast for Merck Serono's and Teva's oral cladribine (Mylinax) in the seven major markets, 2007-2017

Figure 22: Datamonitor's 2007 and updated sales ($m) forecast for Novartis's FTY720 (fingolimod) in the seven major markets, 2007-2017

Figure 23: Datamonitor's 2007 and updated sales ($m) forecast for Biogen Idec's BG-12 (Panaclar) in the seven major markets, 2007-2017

Figure 24: Datamonitor's 2007 and updated sales ($m) forecast for BioMS and Eli Lilly's MBP8298 (Dirucotide) in the seven major markets, 2007-2017

Figure 25: Datamonitor's 2007 and updated sales ($m) forecast for Teva and Active Biotech's laquinimod in the seven major markets, 2007-2017

Figure 26: Multiple sclerosis-specific sales ($m) forecast for alemtuzumab (Campath) in the seven major markets, 2007-2017

Figure 27: Datamonitor's 2007 and updated sales ($m) forecast for Sanofi-Aventis's teriflunomide in the seven major markets, 2007-2017

Figure 28: Datamonitor's 2007 Rituxan and updated ocrelizumab multiple sclerosis-specific sales ($m) forecast for in the seven major markets, 2007-2017

Abstract

Introduction

Spurred by uptake of Biogen Idec and Elan's Tysabri (natalizumab) and continued revenue growth for the three beta-interferon brands and Teva's Copaxone (glatiramer acetate), the seven major multiple sclerosis market value increased 15.1% from 2006 to $5.3 billion in 2007.

Scope

• This report gives a strategic analysis of the likely impact that recent events will have on the future multiple sclerosis market
• Includes multiple sclerosis-specific sales forecasts for the key brands and pipeline agents in the seven major markets to 2017
• Provides a global market snapshot by including multiple sclerosis-specific sales analysis for leading brands outside the seven major markets
• Key conclusions are supported by key opinion leader comment

• Despite the recent confirmation of two new cases of progressive multifocal leukoencephalopathy (PML), with a much stronger 2007-08 enrollment rate than previously anticipated and a greater level of confidence among opinion leaders, Datamonitor has upgraded its Tysabri's forecast.
• Datamonitor remains highly positive on Novartis's FTY720 (fingolimod). FTY720 is expected to achieve the greatest sales of all current late-stage pipeline products. However, sales growth will be restricted from 2012 by the later launch of additional oral pipeline disease-modifiers, which will represent tough direct competition.
• Genzyme and Bayer Schering's alemtuzumab (Campath) has been added to this latest multiple sclerosis forecast. Potentially positioned in both the earliest stages of the disease and for rapidly progressing patients refractory on other therapies, a poor perceived safety profile and an assumed low price-point, will limit returns from this market.

• Understand when late-stage pipeline products will launch and what impact these will have on the market during the forecast period 2008 to 2017
• Quantify the current size of the seven major markets and the trends in the rest of the world
• Assess the impact of events, such as patent expiries and new product launches, on the multiple sclerosis-specific sales of key brand name products

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