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Bayer, J&J’s Xarelto Bests Warfarin in Key Study

Johnson & Johnson and Bayer AG’s blood thinner Xarelto prevented strokes in patients with an erratic heartbeat better than standard therapy with warfarin in a study, without raising the risk of bleeding.

Patients taking Xarelto once a day were 21 percent less likely to suffer a stroke or embolism than those on warfarin, a 56-year-old medicine first used as rat poison, researchers said at the American Heart Association’s annual meeting in Chicago. A second analysis of the data using more stringent methods found Xarelto was equal to warfarin. Bleeding risk, a feared side effect of therapy, was similar.

The study positions Xarelto to take at least a third of the market for warfarin replacements, following the approval of a rival drug called Pradaxa in the U.S. last month, Savant Ahmed, a London-based analyst for the Royal Bank of Scotland, said in an e-mail. Bayer has estimated the market for new blood-thinners including Xarelto could surpass $14 billion in annual sales.

“If you look at the data, Pradaxa and Xarelto are just a lot better than warfarin,” Leslie Iltgen, a Frankfurt-based analyst at Bankhaus Lampe KG, said in a telephone interview. The market is big enough to support both drugs, said Lampe, who recommends buying Bayer shares.

Xarelto may generate combined peak sales for Bayer and Johnson & Johnson of $3.9 billion by 2020, according to estimates from Sanford C. Bernstein & Co. Their calculations assumed the Bayer drug would be about as effective as Boehringer Ingelheim GmbH’s Pradaxa.

Bayer Gains

Bayer gained 2.09 euros, or 3.9 percent, to 56.13 euros at the 5:30 p.m. close of trading in Frankfurt, the biggest advance in more than three months. J&J climbed 47 cents, or less than 1 percent, to $64.14 at 4 p.m. in New York Stock Exchange composite trading.

Xarelto and Pradaxa allow patients to avoid the repeat laboratory tests needed to ensure proper levels of warfarin. Xarelto sales may exceed 2 billion euros ($2.73 billion) a year, Bayer Chief Executive Officer Marijn Dekkers estimated in an interview last month. Frank Misselwitz, head of Bayer’s cardiovascular unit, repeated the estimate today and called it “conservative.”

The study included 14,264 patients with atrial fibrillation who were at high risk for having a stroke. The condition occurs when the upper chambers of the heart quiver rather than contract, allowing blood to pool and form into clots. More than 2.5 million Americans suffer from it and 11,000 die every year.

Once a Day

In the study, 1.7 percent of patients taking Xarelto had a stroke or a blood clot in another part of the body, compared with 2.2 percent of those given warfarin.

“We have a drug you can take once a day, without monitoring, that is at least as good as warfarin and carries no additional risk,” said Robert Califf, the study co-chairman and vice chancellor for clinical research at Duke University Medical Center in Durham, North Carolina. “The findings as we dive into the details of the data look better and better.”

When the researchers included patients who stopped the medicine before the trial was complete, 2.1 percent of those on Xarelto and 2.4 percent of those on warfarin had a stroke or a clot, a difference that was no longer statistically significant.

The study was funded by New Brunswick, New Jersey-based Johnson & Johnson and Germany’s Bayer.

Bayer’s View

“The trial exceeded expectations,” Bayer’s Misselwitz said in a telephone interview today, adding that the results don’t put Xarelto at a disadvantage compared with Pradaxa.

Boehringer’s Pradaxa, taken twice a day, reduced the risk of strokes in its pivotal study by 34 percent without additional bleeding. The trial didn’t mask which drug patients were taking, which can skew the results, and included a less-sick patient population.

Pradaxa sales have been moving “at a very nice pace” compared with what the company anticipated, said Wa’el Hashad, Boehringer’s vice president, cardiovascular and metabolic disorders marketing, in a telephone interview. Many insurance companies waived the standard waiting period to cover new medications, and the company has concluded its scientific presentations at most major insurers.

While researchers cautioned against comparing the two drugs and their respective studies, doctors will have to choose if Xarelto is approved. Johnson & Johnson plans to file for U.S. Food and Drug Administration approval of the drug for patients with atrial fibrillation before the end of the year. Bayer will do the same in Europe, Misselwitz said.

More Drugs

There are more than a half-dozen pills now in development to prevent blood clots from forming in patients with the erratic heart rate known as atrial fibrillation. Pfizer Inc. and Bristol-Myers Squibb Co. are next in line, with data expected from their warfarin replacement, known as apixaban, next year.

“We see ample room for many blockbuster players, given the substantial market opportunity with no ‘one size fits all’ drug,” Jami Rubin, an analyst at Goldman, Sachs & Co. in New York, said in a Nov. 4 note to investors. The market opportunity is a “rare bright spot” for drug companies who have struggled to develop new blockbuster treatments to replace medicines going off patent, she said.

Merck & Co. is working on a rival medication known as betrixaban that it licensed from Portola Pharmaceuticals Inc. in 2009. The drug is in the second of three stages of testing. Tokyo drugmaker Daiichi-Sankyo Co. has a similar product in late-stage testing.

Bleeding Risk

Patients taking Xarelto had slightly higher risks of nuisance bleeding, such as oozing from a wound, and needed more transfusions, according to Califf. The risk of more serious bleeding, including hemorrhage in the brain or those leading to death, was cut by about half, he said.

“These data show pretty convincingly that we have a real alternative here that is effective, that’s better than warfarin, that’s easy to manage and is once daily,” Peter DiBattiste, vice president of cardiovascular development at Johnson & Johnson. “We don’t have any safety signal of concern. This is a real solution for patients who have been struggling with warfarin for 60 years.”

Both Xarelto and Pradaxa, from Ingelheim, Germany-based Boehringer, appear to reduce the risk of the most dangerous, deadly bleeding, Califf said. The findings suggest the drugs, and perhaps the entire class of medicines, don’t cause the same side effects as warfarin. While the hypothesis needs to be confirmed, the implication is that even patients who do well with warfarin may benefit from one of the newer drugs, he said.

There were few discontinuations, and the drug didn’t seem to have the problem with stomach upset including abdominal pain seen with Pradaxa or the higher rate of heart attack, he said.

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