Market Report Source

Overview

Introduction
Traditionally, the treatment of respiratory infections has largely involved antibiotics from the macrolide class. Advanced Life Sciences’ cethromycin, along with Sanofi-Aventis’ Ketek, is a ketolide, a second-generation class of macrolides with activity against bacterial strains resistant to macrolides. Data from two Phase III trials in community-acquired pneumonia are expected in early 2007.

Scope
Analyzes the potential for FDA approval and the market outlook for Advanced Life Sciences’ cethromycin
Datamonitor interviewed six infectious disease specialists and high-prescribing primary care physicians in the course of research
Highlights
While there is some risk, dosing improvements over previous failed trials give cethromycin a good chance of yielding positive results in ongoing Phase III trials.

We expect slow, steady erosion in market share of the macrolide class by the ketolides, driven by concerns over resistant strains of pathogens, but tempered by the established position of Pfizer’s leading macrolide, Zithromax, and the price discounts offered by its generic form.

Recent concern over liver toxicity associated with Sanofi-Aventis’ Ketek, is likely to make physicians wary of cethromycin as well before its side effect profile is better known.

Reasons to Purchase
Understand the commercial potential for Advanced Life Sciences’ cethromycin, through in-depth analysis based on interviews with leading experts
Anticipate likely changes in the future market dynamics for antibacterial agents if cethromycin were to be approved”

Table of Contents

SUMMARY

Cethromycin: Phase III success should allow for ‘me-too’ market entry and above consensus growth

ADVANCED LIFE SCIENCES

Overview

Cethromycin

THE CURRENT RESPIRATORY INFECTION MARKET

Overview

Respiratory infections are primarily treated with macrolides or fluoroquinolones

Cethromycin would be a second-in-class ketolide agent behind Sanofi-Aventis’ Ketek

CETHROMYCIN CLINICAL TRIALS

Two Phase III trials are enrolling to evaluate cethromycin 300 mg once-daily in CAP

We expect complete trial enrollment by year-end 2006 and top line results in Q1 2007

Previous single arm studies demonstrated efficacy in CAP

Comparator trials of 150 mg dose of cethromycin failed in bronchitis and pharyngitis

Trial success likely based on pharmokinetics differences between doses

Cethromycin has low activity against H. influenzae, but unlikely to affect CAP trial

FACTORS IMPACTING CLINICAL USE

With generic formulations of leading brands available, macrolide use may persist

Cethromycin’s Phase III trial uses an inferior competitor; likely to hurt marketing efforts

Ketek’s recent toxicity case report could create cautious attitudes toward cethromycin

Despite obstacles, cethromycin could take share from Ketek due to rare side effect

Ketolide class is not overcrowded; cethromycin will help establish positioning

With a CAP indication, cethromycin is likely to be used liberally off-label

Success of cethromycin would be highly dependent on aggressive marketing

CETHROMYCIN FORECAST

Physicians indicate that the ketolide market could support another agent

Abbott collaboration and royalty structure

APPENDIX

Datamonitor Healthcare

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List of Tables

Table 1: Expected Milestone events for cethromycin

Table 2: Phase II data for cethromycin in respiratory infections

Table 3: Phase III data for cethromycin in respiratory infections

Table 4: Ketolide Class Forecast – 2006-2012 14