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Tysabri withdrawn from market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