The Bristol and Pfizer Blood Thinner: 'A Major Win'

Includes: BMY, PFE
by: Pharmalot

Late Wednesday, Pfizer (NYSE:PFE) and Bristol-Myers Squibb (NYSE:BMY) released results of a Phase III trial for the forthcoming apixaban blood thinner and the news appears to be a huge win for the drugmakers - the med prevented more strokes with less major bleeding than warfain, which is the standard treatment in patients with atrial fibrillation. The outcome surpassed expectations and is creating a stir among analysts.

Here’s why: Wall Street expected the study would show that apixaban, which will be marketed commercially as Eliquis, would only meet its primary goal of showing non-inferiority to warfarin in preventing strokes and clots. For instance, a survey conducted by ISI Group analyst Mark Schoenebaum found that 80 percent of 234 buy-side investors expected non-inferiority efficacy.

Only sparse results were issued (see here) and complete data will be available at the European Society of Cardiology Congress in August, but Wall Street now anticipates that apixaban will have a big edge on rival meds in the $7 billion market for blood thinners. Notably, there is the recently approved Praxada treatment from Boehringer Ingelheim that is being widely promoted to consumers, as well as the Xarelto med from Bayer (OTCPK:BAYZF) and Johnson & Johnson (NYSE:JNJ) that awaits FDA approval.

“Assuming no warts in the data when presented at ESC, we believe apixaban could become the leader in the warfarin-replacement market since the drug is apparently better than warfarin with safety similar to aspirin,” writes Leerink Swann analyst Seamus Fernandez in an investor note in which he bumped his apixaban sales estimates by $850 million, to $3.1 billion, in 2017.

He adds that Pradaxa demonstrated superior efficacy, but not safety, compared with warfarin with twice-daily dosing and gastrointestinal tolerability issues. And while Xarelto does have an advantage, because this is a once-a-day treatment, the med proved non-inferior to warfarin in more severe patients on both efficacy and safety.

In his own note, Schoenebaum opines that apixaban appears to be the only blood thinner with superior efficacy and safety, as far as bleeding goes, and so could grab up to 50 percent of the “treated non-valvular a-fib market.” What might that mean? As much as $3.5 billion global sales of a-fib alone. Previously, he forecast a market share of just 18 percent.

“Recall that Pradaxa was superior to warfarin as well. However, that trial was open label, and thus the level of ‘evidence’ for superiority is not ideal,” Schoenebaum writes to investors. The apixaban trial, however, “was a blinded trial. Thus, we believe the ’superiority’ conclusion will probably be viewed by physicians as stronger than that for Pradaxa. Although it’s possible that the ultimate FDA label does not officially include a superiority claim (FDA sometimes requires 2 trials for superiority label claims), we still believe these data will be highly compelling to physicians.”

Meanwhile, Wells Fargo Securities analyst Larry Biegelsen wrote that “our model assumes Xarelto and apixaban each capture about 30 percent of the stroke prevention for atrial fibrillation (SPAF) indication, with BI’s Pradaxa capturing the remainder among the new anticoagulants given Pradaxa’s first mover advantage. However, this data suggests that apixaban should capture a greater portion of the market than we currently model.”

He does add, though, that Xarelto may have some advantages. For one, Bristol-Myers plans to seek FDA approval late this year, giving Xarelto a head start of about six to 12 months, assuming Xarelto is approved in the US later this year. Then there’s once-a-day dosing for Xarelto compared with twice daily for apixaban; Xarelto should receive an orthopedic indication in the US, which apixaban is unlikely to win; Xarelto may still be able to receive an acute coronary syndrome indication if data from a forthcoming study is positive; apixaban, he notes, failed in this indication; and Xarelto should receive a an indication for treating deep vein thrombosis about a year before apixaban. Nonetheless, he calls the apixaban a “major win.”