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Advanced Life Sciences' Cethromycin - Phase III success should allow 'me-too' market entry

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

Report 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

Table of Contents

• SUMMARY - page 1
  • Cethromycin: Phase III success should allow for 'me-too' market entry and above consensus growth - page 1
• ADVANCED LIFE SCIENCES - page 5
  • Overview - page 5
  • Cethromycin - page 5
• THE CURRENT RESPIRATORY INFECTION MARKET - page 5
  • Overview - page 5
  • Respiratory infections are primarily treated with macrolides or fluoroquinolones - page 6
  • Cethromycin would be a second-in-class ketolide agent behind Sanofi-Aventis' Ketek - page 6
• CETHROMYCIN CLINICAL TRIALS - page 7
  • Two Phase III trials are enrolling to evaluate cethromycin 300 mg once-daily in CAP - page 7
  • We expect complete trial enrollment by year-end 2006 and top line results in Q1 2007 - page 7
  • Previous single arm studies demonstrated efficacy in CAP - page 7
  • Comparator trials of 150 mg dose of cethromycin failed in bronchitis and pharyngitis - page 8
  • Trial success likely based on pharmokinetics differences between doses - page 8
  • Cethromycin has low activity against H. influenzae, but unlikely to affect CAP trial - page 9
• FACTORS IMPACTING CLINICAL USE - page 9
  • With generic formulations of leading brands available, macrolide use may persist - page 9
  • Cethromycin's Phase III trial uses an inferior competitor; likely to hurt marketing efforts - page 10
  • Ketek's recent toxicity case report could create cautious attitudes toward cethromycin - page 11
  • Despite obstacles, cethromycin could take share from Ketek due to rare side effect - page 12
  • Ketolide class is not overcrowded; cethromycin will help establish positioning - page 12
  • With a CAP indication, cethromycin is likely to be used liberally off-label - page 12
  • Success of cethromycin would be highly dependent on aggressive marketing - page 13
• CETHROMYCIN FORECAST - page 13
  • Physicians indicate that the ketolide market could support another agent - page 13
  • Abbott collaboration and royalty structure - page 14
• APPENDIX - page 16
  • Datamonitor Healthcare - page 16
  • Disclosure information - page 16
  • Ask the analyst - page 17


• List of Tables
• Table 1: Expected Milestone events for cethromycin - page 5
• Table 2: Phase II data for cethromycin in respiratory infections - page 8
• Table 3: Phase III data for cethromycin in respiratory infections - page 8
• Table 4: Ketolide Class Forecast - 2006-2012 - page 14

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