Xarelto - Bayer and Johnson & Johnson

Xarelto (rivaroxaban)
Bayer and Johnson & Johnson
Launch Date:
2008 in EU, November 2011 in U.S.
First-Year Sales: €322 million for Bayer; $239 million for J&J
First-Half 2013 Sales: €374 million for Bayer; $347 million for J&J
Analyst Estimate for 2018: $3.68 billion

Xarelto made its debut in Europe as a clot preventive for surgery patients. But it didn't win its key approval--to prevent stroke in patients with atrial fibrillation--until November 2011 in the U.S. and December 2011 in the EU. That put it a year behind its head-to-head rival Pradaxa (dabigatran) from Boehringer Ingelheim.

But Xarelto has already caught up. Boehringer reported €612 million in Pradaxa sales for the first half of this year, or about $827 million. Between Johnson & Johnson's $347 million and Bayer's €374 million, Xarelto racked up about $847 million. At that rate, it will smoke past the blockbuster barrier by Dec. 31, in its second full year on the market.

In a way, Xarelto shows that being second to the party can be a good thing. Pradaxa has had to bear the burden of a steep learning curve; doctors well-versed in dealing with the cantankerous standard therapy, warfarin, may have relaxed their guard a bit too much. Deaths and serious bleeding prompted Boehringer to warn physicians that they should test kidney function first, before prescribing Pradaxa, to avoid inadvertent overdoses that put patients at greater risk of bleeding. Pradaxa is now the subject of hundreds of lawsuits, and liability lawyers are trolling for more. That's despite the fact that the number of deaths and serious bleeds hews pretty closely, statistically speaking, to the rate seen in clinical trials, and regulators have backed the drug's safety.

By the time Xarelto came onto the scene, physicians were a bit wary of the new generation of anticoagulants. They worried about serious bleeding and the lack of a quick antidote. That didn't stop them from prescribing the drug--otherwise Xarelto wouldn't have brought in $239 million last year for J&J and another €322 million for Bayer. But they might have been more careful to select the proper patients than they were before the bleeding worries arose. Plus, Bayer and J&J could quickly say they were working on an antidote (just as Boehringer is).

Bayer and J&J have also had some success at broadening Xarelto's market. Last November, the drug won approval in Europe to prevent and treat pulmonary embolism and deep vein thrombosis. The big prize is acute coronary syndrome, a catchall category that encompasses any malady caused by sudden blockage to the heart's blood supply, such as heart attacks and unstable angina; an estimated 1.2 million ACS patients are hospitalized annually in the U.S. Xarelto was the only one of the new generation of anticoagulants to generate strong enough data to warrant an application for approval. Bayer won a European approval in May to prevent heart attacks, strokes and death in ACS patients. But J&J, which markets the drug in the U.S., has been turned away twice by the FDA. And the FDA rejected J&J's app for another potential lucrative use: to prevent clots in stent patients.

Now, Bayer and J&J are tackling even bigger markets. Bayer has embarked on a 20,000-patient study to evaluate how well Xarelto, combined with aspirin, can hold off heart attack, death and stroke in patients with coronary or peripheral artery disease. Plus, J&J is preparing to test Xarelto on patients with chronic heart failure and significant coronary artery disease.

Those studies won't be wrapped up for years, however, and in the meantime, Xarelto has a new threat to contend with: Eliquis (apixaban), the third entry onto the warfarin-alternative scene. After a series of delays, it finally won FDA approval at the end of 2012. Because trial data on Eliquis is particularly strong, the Pfizer ($PFE) and Bristol-Myers Squibb ($BMY) drug was expected to grab a big share of the new anticoagulant market. So far, that hasn't happened; as Pfizer announced earnings recently, executives acknowledged that Eliquis uptake had so far been disappointing at $17 million for the first quarter and even less for the second. That could change, however, and soon.

Still, Xarelto is in a strong position, with more indications than Pradaxa or Eliquis. Analysts figure Bayer and J&J together could reap about $3.7 billion in sales by 2018. Bayer CEO Marijn Dekkers has repeatedly predicted that his company alone would hit $2.5 billion with Xarelto.

For more:
Special Report: Top Pharma Companies by 2012 Revenues - Bayer - J&J
German regulators see no new risks with Bayer's Xarelto
Bayer, J&J test Xarelto uses, even as ACS indication eludes
Bayer, J&J's Xarelto again falls short in bid for ACS use
Fight for anticoagulant market heats up with antidote deals
Bayer gambling $4B budget on Xarelto, top blockbuster hopefuls

-- Tracy Staton (email | Twitter)

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Xarelto - Bayer and Johnson & Johnson