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Advanced Life Sciences Cethromycin - Phase III Success Should Allow Me-too Market Entry and Above-consensus Growth


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


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


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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Please fax this form to:
(646) 607-1907 or (646) 964-6609 - From USA
+353 1 481 1716 or +353 1 653 1571 - From Rest of World