Theravance
Telavancin Shows Trend towards Superiority
Theravance released positive data from two phase III telavancin studies in serious
skin infections, which achieved the primary endpoint of non-inferiority vs.
vancomycin, and showed a strong trend toward superiority in patients with
resistant (MRSA) infection. Given the strong superiority trend, we believe there is
a significant probability that telavancin will achieve superiority for MRSA patients
in the hospital-acquired pneumonia (HAP) study, which should be released in
mid-07. Safety appeared consistent with prior studies, but should be elucidated
on its 8 AM conference call. Reiterate BUY.
Achieves Non-Inferiority vs. Vanco
The telavancin phase III studies in complicated skin & soft structure infections
achieved the primary endpoint of non-inferiority in clinical cure rate vs.
vancomycin, and also demonstrated a strong trend towards superiority.
Strong Trend To Superiority
Most important for its commercial positioning, the drug was able to demonstrate a
strong trend toward superiority in clinical cure rate vs. vancomycin in patients with
methacillin-resistant staph aureus (MRSA). Telavancin showed a clinical cure
rate of 90.6% vs. vanco’s clinical cure rate of 86.4% (p=0.06).
Strong Trend Suggests High Chance of Superiority in HAP
Study
A strong trend to superiority in the skin study for MRSA patients suggests a high
likelihood of showing superiority in the HAP study, which should have data in mid-
07. The high cure rate in the vanco arm of the skin study makes it difficult to
demonstrate a big enough difference to hit significance. But, the cure rate for the
control group in the HAP study is expected to be much lower, which should allow
a significant difference to be more easily shown.
Full Safety Data Not Yet Released
The press release described the safety profile as consistent with other studies
including small percentages of kidney adverse events or increases in the QTc
interval. For safety to be as expected, kidney toxicity should occur in less than
5% of patients, it should be mild to moderate and transient. The QTc interval
prolongation should not be associated with other events such as arrhythmias or
fainting. |
