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Cethromycin achieves all endpoints in second pivotal Phase III Trial for treatment for pneumonia
Date:11/15/2007

establishes non-inferiority. Under this analysis, the study met the radiographic success rate endpoint in the mITT population. Since p>0.05, there is not a statistically significant difference between cethromycin and Biaxin, which supports non-inferiority.

  • Bacteriological cure rate- cethromycin 95.9% (70 subjects/73 subjects) compared to Biaxin 97.1% (67 subjects/69 subjects). The bacteriologically evaluable population for each arm of the trial was not powered to demonstrate statistical non-inferiority at a 95% confidence interval.

  • Percent of bacteriologically evaluable patients- approximately 33% of subjects in the per protocol population were bacteriologically evaluable. The Company believes that this percentage of bacteriologically evaluable patients is consistent with rates observed in precedent successful antibiotic drug approvals and that it will add to its existing bacteriologically evaluable patient database for cethromycin.

  • Discontinuation rate- from the modified intent-to-treat population, discontinuation rate due to adverse events was 4.2% for cethromycin and 2.8% for Biaxin.

Cethromycin demonstrated a favorable safety profile in Trial CL-05. The incidence of adverse events was not statistically different between cethromycin and Biaxin. The most common adverse events reported in patients receiving cethromycin were mild-to-moderate diarrhea (cethromycin 4.5%, Biaxin 4.1%), headache (cethromycin 2.4%, Biaxin 3.1%), nausea (cethromycin 4.5%, Biaxin 1.4%), vomiting (cethromycin 1.4%, Biaxin 1.0%), abdominal pain (cethromycin 1.4%, Biaxin 1.4%) and taste disturbance (cethromycin 7.6%, Biaxin 2.1%). No drug-related serious adverse events were observed in any study subject. Liver function tests and electrocardiogram monitoring in Trial CL-05 demonstrated no significant differences between subjects receiving cethromycin and subjects receiving Biaxin.

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Contact: Melanie Nimrodi
mnimrodi@mww.com
312-546-3508
MWW Group
Source:Eurekalert

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