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[DewDiligence]

Here’s the Reuters newswire on Rivaroxaban. Please see
#msg-25147464 and #msg-24337258 for prior info on this drug.

http://www.reuters.com/article/marketsNews/idINL3067779620080530

>>
Bayer, JNJ Clot-Drug Success Lifts US Prospects

Fri May 30, 2008 7:21am EDT
By Ransdell Pierson

NEW YORK, May 30 (Reuters) - A drug being developed by Bayer AG (BAYG.DE) and Johnson & Johnson (JNJ) has again proven better than a standard treatment in preventing dangerous blood clots among patients undergoing orthopedic surgery, boosting its chances for U.S. approval.

The results were seen in a late-stage trial of the medicine rivaroxaban, or Xarelto, which involved 3,148 patients undergoing knee replacement surgery in the United States and overseas, the companies said on Friday.

Like three earlier Phase III trials, rivaroxaban proved safe and significantly more effective than Sanofi-Aventis SA's (SNY) widely used Lovenox, now the gold standard in preventing blood clots among patients recovering from knee- and hip-replacement surgery.

Shares in Germany's Bayer rose 1.5 percent to 57.22 euros after the news.

"The data tell us we have a true medical advance here because, in consecutive studies, it has showed compelling superiority to a drug that works really well," Peter DiBattiste, J&J's head of cardiovascular medicine, said in an interview.

In the latest trial, patients taking rivaroxaban for 14 days had a 31 percent reduced risk of serious blood clots -- including clots in blood vessels of the leg and of the lung -- and death from all causes compared with patients taking Lovenox for the same period.

The rate of major bleeding, the main safety measure of the trial, was numerically higher for rivaroxaban than Lovenox, but the difference was not statistically significant.

"We had not expected superiority. In that respect, the outcome is all the more positive," Frank Misselwitz, Bayer's head of cardiovascular clinical development, told Reuters. "We have practically proved superiority against the comparative treatment regime with this fourth study in a row."

PIVOTAL STUDY

Previous large trials pitted once-daily rivaroxaban against the daily 40-milligram dose of Lovenox recommended outside the United States after orthopedic surgery.

The newest study is considered pivotal for the drug's potential U.S. approval because it instead compared rivaroxaban to the overall higher 60 milligram Lovenox doses recommended in the United States -- 30 milligram pills of the Sanofi drug given twice daily.

Results of the latest trial, called Record 4, were presented in Nice, France at the annual meeting of the European Federation of National Associations of Orthopaedics & Traumatology.

"We have deliberately waited for the outcome of Record 4 study before we seek approval from U.S. authorities," Misselwitz said.

In an earlier two-week trial involving patients recovering from knee-replacement surgery, blood-clot risk was reduced 49 percent in the rivaroxaban group compared with those receiving the standard lower total dose of Lovenox used overseas, J&J said.

The most impressive results were seen in the first late-stage study, which involved patients treated after hip-replacement surgery. DiBattiste said rivaroxaban reduced clotting risk 70 percent during the 35-day treatment period, compared with Lovenox.

Rivaroxaban, which works by blocking a protein called Factor Xa involved in the clotting process, is also being tested to see how well it prevents strokes among patients with a heart-rhythm abnormality called atrial fibrillation. [However, the lack of FIIa inhibition figures to be a disadcantage in arterial settings.]

Use of the drug among atrial fibrillation patients is considered to have a far larger sales potential because it would be taken every day on a long-term basis, rather than for the limited periods needed after orthopedic surgery.

Bristol-Myers Squibb Co (BMY) and Pfizer Inc (PFE) are developing a potential rival medicine, called apixaban, that also works by blocking Factor Xa [#msg-19134406, #msg-21044973]. But it needs to be taken twice daily, a potential marketing disadvantage.
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