Bayer left playing catch-up with BMS after Xarelto failure

Bayer has said a failed trial for a potential new use of anticoagulant Xarelto will not affect forecast peak sales of $5 billion – although it will not help it gain ground on Bristol-Myers Squibb’s dominant rival, Eliquis.

Bayer and development partner Janssen halted the phase 3 NAVIGATE ESUS study of Xarelto (rivaroxaban) after it showed the drug was no more effective than aspirin and with a higher risk of bleeding.

The study was testing Xarelto in secondary prevention of stroke and systemic embolism in patients with a recent embolic stroke of undetermined source (ESUS).

But Bayer halted the trial early on the recommendation of its independent monitoring committee following a planned interim analysis.

The results come at a bad time for Xarelto, which is playing catch-up with Bristol-Myers Squibb’s rival novel oral anticoagulant, Eliquis.

In the last quarter, Eliquis took a commanding lead over Xarelto, with sales increasing 51% to just under $1.2 billion.

While Xarelto’s sales were up 18.6% compared with last year’s Q2 to $834 million, Bayer’s chances of toppling Eliquis as market leader look slim.

Boehringer Ingelheim’s rival Pradaxa is also a blockbuster but seems firmly in third place after generating sales of around $1.5 billion for all of last year.

Bayer said that failing to gain the new indication will not affect peak sales forecasts of around $5 billion – but it will not help it win market share from BMS.

Interim analysis

The analysis showed comparable efficacy between the rivaroxaban and aspirin arms and very little chance of showing overall benefit if the study were completed.

While bleeding rates were low overall, there was an increase in bleeding in the rivaroxaban arm compared with the low dose aspirin arm.

ESUS refers to patients with embolic stroke documented by neuroimaging for which the cause remains unidentified despite thorough investigations attempting to rule out established cardiac and vascular sources.

It does not include patients with atrial fibrillation or established atherosclerotic disease and therefore the patient population in NAVIGATE ESUS differs from the currently approved indications for rivaroxaban. Despite recommended treatments, the stroke recurrence risk for patients with ESUS remains substantial.

With the NOAC drugs, pharma companies have produced novel anticoagulants designed to replace warfarin by reducing the risk of stroke and other damaging blood clots with a lower risk of bleeding.