Cethromycin Achieves All Endpoints in Second Pivotal Phase III Trial for Treatment of...( subjects) [-4.9 +5.6] (p0.9999). ...),Health

subjects) [-4.9, +5.6] (p>0.9999). Based on the 92.7% radiographic

success rate for cethromycin being greater than 90%, a delta value of

10% or less on the lower bound and greater than zero on the upper

bound [-4.9, +5.6] establishes non-inferiority. Under this analysis,

the study met the radiographic success rate endpoint in the PPc

population. Since p>0.05, there is not a statistically significant

difference between cethromycin and Biaxin, which supports

non-inferiority.

-- Modified intent-to-treat radiographic success rate -- cethromycin

82.4% (215 subjects/261 subjects) compared to Biaxin 81.5%

(207 subjects/254 subjects) [-6.0, +7.7] (p=0.8195). Based on the

82.4% radiographic success rate for cethromycin being between 80% and

90%, a delta value of 15% or less on the lower bound and greater than

zero on the upper bound [-6.0, +7.7] 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 ad
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