Pfizer, Inc. (PFE) and partner Bristol-Myers Squibb presented data on their anti-clotting drug Eliquis (apixaban) at the 2013 ESC Congress in the Netherlands. The companies presented the results on Eliquis from a subanalysis of the phase III ARISTOTLE study.
The study evaluated the efficacy and safety of Eliquis versus warfarin for the preventing stroke or systemic embolism in patients suffering from nonvalvular atrial fibrillation (NVAF). Atrial fibrillation refers to a cardiac rhythm disorder characterized by an erratic heartbeat.
The subanalysis evaluated Eliquis versus warfarin in 4,808 NVAF patients (26.4% of the patients evaluated in the ARISTOTLE study) with or without other types of valvular heart disease. Data from the subanalysis was found to be consistent with the results of the overall ARISTOTLE study.
In particular, data revealed that treatment with Eliquis reduced stroke or systemic embolism, caused fewer major bleeding events and reduced all-cause mortality compared to those treated with warfarin.
Late last month, Pfizer and Bristol-Myers presented results from a post-hoc sub-analysis of the ARISTOTLE trial at the ESC Congress 2013. The sub-analysis was carried out to determine the overall rates of key post-procedural outcomes, such as stroke or systemic embolism and major bleeding, among Eliquis and warfarin patients who underwent a procedure during the ARISTOTLE trial. The sub-analysis also examined differences in post-procedural events according to whether or not the study drug was continued.
The companies said that in the 30-day period following a procedure, rates of clinical events (stroke or systemic embolism, major bleeding, and all-cause death) were comparable in the Eliquis and warfarin arms.
Event rates in the 30-day period following a procedure in patients in the Eliquis arm were similar irrespective of Eliquis being stopped prior to the procedure or continued during the procedure. However, in the warfarin arm, a minimum twofold higher rate of major bleeding and death was observed during the 30-day period following a procedure when warfarin was continued during the procedure compared to when warfarin was stopped before the procedure.
We note that the anti-coagulant market currently includes Bayer/Johnson & Johnson’s (BAYRY/JNJ) blood-thinner Xarelto. Moreover, the arrival of Boehringer Ingelheim’s Pradaxa has intensified competition in the market.
Pfizer carries a Zacks Rank #3 (Hold). Pfizer’s second quarter 2013 results were mixed with earnings slightly above expectations and revenues continuing to lag expectations. We believe revenues will remain under pressure due to genericization and the expiration of a few co-promotion agreements. However, cost-cutting efforts and share buybacks should help the company achieve its 2013 earnings guidance. Pfizer expects earnings of $2.10 – $2.20 per share in 2013. Gilead Sciences Inc. (GILD) appears to be very attractive with a Zacks Rank #1 (Strong Buy).
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