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Advanced Life Sciences Cethromycin - Phase III Success Should Allow Me-too Market Entry and Above-consensus Growth
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Description: |
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 of this title: - Analyzes the potential for FDA approval and the market outlook for Advanced Life Sciences cethromycin - We interviewed six infectious disease specialists and high-prescribing primary care physicians in the course of research
Highlights of this title: - 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 Pfizers 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 order your copy: - 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
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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 7 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 Cethromycins Phase III trial uses an inferior competitor likely to hurt marketing efforts Keteks 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 Healthcare Disclosure information Ask the analyst
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
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Companies Mentioned |
Pfizer
Advanced Life Sciences
Sanofi-Aventis
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Advanced Life Sciences Cethromycin - Phase III Success Should Allow Me-too Market Entry and Above-consensus Growth
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