Johnson & Johnson ($JNJ) and Bayer's Xarelto made its way to the front of the new-age anticoagulant pack not long after hitting the U.S. market, gaining ground from rival Pradaxa to head what has since become a three-horse race. And that's ground its makers aren't ready to cede.
The companies last week widened their R&D program for the drug, a move that could solidify its lead. Bayer and J&J have added three new trials to their previous 5-trial lineup in the Xarelto-focused Explorer research program. And one of the additional studies is pitched at gaining a new indication--and market share--for the anticoagulant drug.
That study--Mariner--is designed to determine whether Xarelto reduces the risk of potentially deadly blood clots in the legs and lungs in sick patients discharged from the hospital. It joins two other previously announced indication-seeking Phase III studies evaluating Xarelto in patients with artery diseases, Dr. Anne Vosatka, Xarelto development team leader at J&J's Janssen unit, told FiercePharmaMarketing.
If successful, those trials could help Bayer and J&J build on the 6 indications Xarelto already boasts. Along with its once-daily dosing regimen, that list of approved uses has kept Xarelto "in a solid position to continue market share gain … among the new oral anticoagulants," Wells Fargo analyst Larry Biegelsen wrote in a report last week. And the R&D expansion won't likely stop there: Bayer recently pledged to spend an extra $600 million on R&D and marketing for its top 5 meds, including Xarelto.
That's not to say Xarelto's competitors haven't racked up new indications of their own. Both runner-up Pradaxa from Boehringer Ingelheim and market trailer Eliquis from Pfizer ($PFE) and Bristol-Myers Squibb ($BMY)--which claimed 3.9% and 2.1% shares of new prescriptions this February, compared with Xarelto's 12.6%--recently grabbed indications related to the prevention of deep vein thrombrosis (DVT) and pulmonary embolism (PE) in some patients. Still, Bigelow says, Wells Fargo expects Xarelto to "capture the lion's share of the $1 billion DVT/PE opportunity for now."
Xarelto made a quick trip to the blockbuster benchmark after its 2011 U.S. approval. In 2013, the drug pulled in $864 million in stateside sales for J&J, not to mention the overseas revenue it scored for Bayer. In a presentation at Cowen & Co.'s Health Care Conference in March, J&J CFO Dominic Caruso credited the success of his company's new hot-selling pharma products not only to their clinical profiles, but also to their appropriate placement "in the formularies and reimbursement, so that patients can access these products."
But in terms of their slice of the overall anticoagulant market, Bigelow says the Xarelto-Pradaxa-Eliquis trio still has plenty of room for expansion. So far, cardiologists have driven their market-share gains in stroke prevention, he noted, but he expects the new group of drugs to make gains over time as primary care providers get more comfortable with their safety and efficacy profile.
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