Pfizer Geodon CV Safety Trial Fully Enrolled; Rx Growth Slows
Executive Summary
Pfizer has completed enrollment in a cardiovascular safety study of the antipsychotic Geodon (ziprasidone), the company told investors during an Oct. 17 conference call.
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Pfizer has completed enrollment in a cardiovascular safety study of
the antipsychotic Geodon (ziprasidone), the company told investors
during an Oct. 17 conference call. "The cardiovascular study is fully enrolled, and once that's
completed we will file for final approval by FDA," Pfizer CEO Henry
McKinnell said. The company believes that the trial will address a disadvantage
it has in labeling regarding the risk of QT/QTc prolongation.
Pfizer Pharmaceuticals President Karen Katen acknowledged that the
QT warning is holding back Geodon's performance. "When deciding among the alternative treatments available for
this condition, the prescriber should consider the finding of
ziprasidone's greater capacity to prolong the QT/QTc interval
compared to several other antipsychotic drugs," Geodon labeling
states. Katen highlighted warnings about co-administration with other
agents likely to increase the QT interval. "That's been a
constraint - along with a lot of counterdetailing by Lilly - that's
been a constraint in our ability to ratchet up the growth pattern"
for Geodon. Geodon sales were $23 mil. during the third quarter, level with
second quarter sales after an initial sell-in of $65 mil. in the
first quarter. Lilly's Zyprexa (olanzapine) is not showing any
adverse impact from the Geodon launch: sales grew 26% to $812.5
mil. during the quarter. Katen maintained that Geodon is tracking ahead of plan. "Right
now, we're over 150% of budget. We're very satisfied with the
performance of the product today." She acknowledged that the most
recent weekly prescription data has not shown continued growth. "We
would like to see it grow more." "When we launch the intramuscular formulation, which should be
relatively soon, we will get a spurt of growth associated with
increased use in emergency rooms," Katen added. Geodon IM is
"approvable." Pfizer did not disclose a timeline for the filing to address the CV labeling. However, McKinnell advised investors to "stay tuned next year." |