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Research and Markets: Understand the Commercial Potential for Advanced Life Sciences Cethromycin, Through In-Depth Analysis Based on Interviews With Leading Experts

Posted on: Thursday, 5 October 2006, 12:01 CDT

Research and Markets (http://www.researchandmarkets.com/reports/c43153) has announced the addition of the new report from Datamonitor "Advanced Life Sciences Cethromycin - Phase III Success Should Allow Me-too Market Entry and Above-consensus Growth" to their offering.

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:

This report 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 include:

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 Include:

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

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

For more information visit http://www.researchandmarkets.com/reports/c43153

Source: Datamonitor

Source: Business Wire

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