Tysabri（ナタリズマブ）の効能と市場再参入動向

Overview

Introduction

Rapid uptake of products focused on drug-resistant infections, such as Pfizers Zyvox (linezolid), has been driven by the increasing numbers of immunocompromised patients in hospitals. Despite these pockets of strong growth, the market for antibacterials, valued at $24 billion in the seven major markets, still faces significant revenue loss in the period 2005-2007 due to major patent expiries.

Scope

• Highlights epidemiological trends in bacterial infections across the major Western markets
• In-depth value analysis per product, class and country, with an assessment of underlying commercial and clinical influencers
• Case study analysis of Pfizers Zmax single dose formulation for respiratory tract infections, including the impact of generic azithromycin
• Examines the outlook for branded Rocephin in the key US market discussion of Sandoz, Lupin, and Hospira strategies for generic ceftriaxone

Highlights

In 2004 the global antibacterial market was valued at approximately $24 billion with modest growth on 2000 (CAGR 4.4%). The fastest growing classes during this period were the carbapenems and "others" with notable products such as Pfizers Zyvox (linezolid).

Although drug resistant infections such as MRSA have been a key focus over recent years, Datamonitors opinion leader research reveals new concerns with Gram negative organisms such as actineobacter, pseudomonas and ESBL producing strains.

Pfizers acquisition of Vircurons dalbavancin and Johnsons and Johnsons investment in both doripenem and ceftobipole brings much need reinvestment to the antibacterial sector and a commitment to combating serious hospital infections.

Reasons to Purchase

• Review the clinical and commercial factors driving new product decisions in antibacterials, and the opportunities and threats facing the market
• Gain insight into the product lifecycle management strategies of the top antibacterial players through real case study analyses
• Understand why 2005 has brought new investment to a previously neglected therapeutic sector

ABOUT DATAMONITOR HEALTHCARE

• About the CNS pharmaceutical analysis team

EXECUTIVE SUMMARY

• Introduction
• Scope and coverage of the Brief
• Key findings

TYSABRI - THE STORY SO FAR

• Tysabri withdrawn from market
• Overview of Tysabri
• Suspension of Tysabri - February 2005
• Linking Tysabri and PML
• Tysabris mechanism of action
• PML
• PML pathology
• Linking Tysabri and PML
• Tysabri monotherapy versus Tysabri/Avonex combination therapy
• Profile of PML patients
• Tysabri plus Avonex leads to drug accumulation and immune supression

CLINICAL TRIAL DATA

• AFFIRM two-year data
• SENTINEL one-year data
• SENTINEL two-year data
• GLANCE data
• ENCORE data - Crohns disease

DATAMONITOR ASSESSMENT AND THOUGHT LEADER OPINION

• Leading neurologists split on Tysabri monotherapy safety
• Action to be taken for Tysabris relaunch
• Potential product labeling of Tysabri
• Tysabri in immunosuppressed patients
• Screening of treatment-na・e and actively treated patients to reduce the risk of PML development
• Formulation of a treatment strategy to be executed if Tysabri patients develop PML
• How will Tysabri be positioned as a treatment strategy?
• Future clinical trials in MS
• Datamonitor Tysabri and monoclional antibody outlook

INTERVIEW TRANSCRIPTS

• Leading neurologists split on Tysabri monotherapy safety
• Interview 1
• Interview 2
• Interview 3
• Interview 4
• Interview 5
• Interview 6
• Interview 7
• Interview 8
• Interview 9
• Interview 10

APPENDIX

• Interviewed KOLs
• Bibliography
• Websites
• Journals and conference abstracts
• Research methodology
• Disclaimer
• List of Tables
• Table 1: Pharmacokinetics of Tysabri and Tysabri/Avonex at 20 weeks of treatment
• Table 2: Details of Tysabri patients with PML
• Table 3: Events since the withdrawal of Tysabri from market in February 2004
• List of Figures
• Figure 1: SWOT analysis of Tysabri
• Figure 2: Tysabri precautions
• Figure 3: Humira black box warning and strong warning on risk of infection
• Figure 4: Remicade black box warning and strong warning on risk of infection
• Figure 5: Novartiss Clozaril CARE website - WBC and ANC monitoring