Research and Markets: Understand the Commercial Potential for Advanced Life Sciences Cethromycin, through In-Depth Analysis Based on Interviews with Leading Experts.DUBLIN, Ireland -- 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 Noun 1. phase III - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the FDA Success Should Allow Me-too Market Entry and Above-consensus Growth" to their offering. Traditionally, the treatment of respiratory infections Noun 1. respiratory infection - any infection of the respiratory tract respiratory tract infection infection - the pathological state resulting from the invasion of the body by pathogenic microorganisms 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 community-acquired pneumonia Pneumonia caused by an infection currently present in the community; CAP is the most common cause of infectious death–US, and number 6 killer overall; of the 57% of CAPs in which a pathogen is identified, S pneumoniae are expected in early 2007. Scope of this title: This report analyzes the potential for FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. approval and the market outlook for Advanced Life Sciences cethromycin. We interviewed six infectious disease Infectious disease A pathological condition spread among biological species. Infectious diseases, although varied in their effects, are always associated with viruses, bacteria, fungi, protozoa, multicellular parasites and aberrant proteins known as prions. 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 toxicity /tox·ic·i·ty/ (tok-sis´i-te) the quality of being poisonous, especially the degree of virulence of a toxic microbe or of a poison. 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 antibacterial /an·ti·bac·te·ri·al/ (-bak-ter´e-al) destroying or suppressing growth or reproduction of bacteria; also, an agent that does this. an·ti·bac·te·ri·al adj. 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 comparator Instrument for comparing something with a similar thing or with a standard measure, in particular to measure small displacements in mechanical devices. In astronomy, the blink comparator is used to examine photographic plates for signs of moving bodies. trials of 150 mg dose of cethromycin failed in bronchitis bronchitis (brŏnkī`tĭs), inflammation of the mucous membrane of the bronchial tubes. It can be caused by viral or bacterial infections or by allergic reactions to irritants such as tobacco smoke. 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 o·ver·crowd v. o·ver·crowd·ed, o·ver·crowd·ing, o·ver·crowds v.tr. To cause to be excessively crowded: a system of consolidation that only overcrowded the classrooms. 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 |
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