Biotech Values

[DewDiligence]

Exceptionally strong Eliquis results in secondary VTE prevention—easily strong enough to overcome the doubts about Eliquis from prior trials in VTE prevention. From BMY/PFE’s own PR:

http://finance.yahoo.com/news/eliquis-apixaban-demonstrated-superiority-reducing-190000748.html

Bristol-Myers Squibb Company and Pfizer Inc. today announced the results of the Phase 3 AMPLIFY-EXT trial, which evaluated treatment with ELIQUIS® (apixaban) over a one-year period compared to placebo for the prevention of recurrent venous thromboembolism (VTE) in 2,486 patients who had already completed 6 to 12 months of anticoagulation treatment for VTE, including deep vein thrombosis (DVT) or pulmonary embolism (PE). In the trial, extended treatment with ELIQUIS 2.5 mg and 5 mg twice daily, demonstrated superiority versus placebo in the reduction of the composite endpoint of symptomatic, recurrent VTE and death from any cause (11.6% in the placebo group, compared with 3.8% and 4.2% in the ELIQUIS 2.5 mg and 5 mg groups, respectively, P<0.001), the primary efficacy outcome of the trial.

ELIQUIS also was superior to placebo for the predefined secondary efficacy outcome of recurrent VTE and VTE-related death (8.8% in the placebo group, compared with 1.7% in both the ELIQUIS 2.5 mg and 5 mg groups). Both of these endpoints, the primary and secondary efficacy outcomes, were statistically significant (p<0.001).

…The rate of the primary safety outcome of major bleeding was comparable across treatment groups (0.2 % for ELIQUIS 2.5 mg; 0.1 % for ELIQUIS 5 mg and 0.5% for placebo). The rate of the composite of major bleeding and clinically relevant non-major bleeding for the 5 mg treatment group (4.3%) was higher versus the placebo group (2.7%), while the rate for the 2.5 mg treatment group (3.2%) was similar to the placebo group.

The findings were published online today in The New England Journal of Medicine…

Note that the 2.5 mg BID dose of Eliquis in the above trial was used only in special dose-reduction situations in the Eliquis trials in AF/stroke prevention, where 5mg BID was the standard dose. For VTE prevention, 2.5mg BID appears to be just as good as the higher dose, so it will presumably be the approved dose in this indication.

I’m already on record with a prediction that, in due course, Eliquis will become the largest-selling drug in history, and nothing in the above press release is a reason to change such a prediction. To the contrary, secondary VTE prevention is not a market in which Elqiuis was expected to do well. Analysts will now have to upgrade their sales projections!