Replies to post #131035 on Biotech Values

[DewDiligence]

Bayer Shares Edge Lower on Xarelto Data

[Bayer’s shares closed today on XETRA at €47.03, down 2.2%.]

http://www.reuters.com/article/2011/11/14/bayer-idUSL5E7ME1S720111114

›Mon Nov 14, 2011 6:29am EST

FRANKFURT, Nov 14 (Reuters) - Bayer shares edged lower on Monday as investors weighed which way study data released over the weekend could tip the balance in the highly contested market for new anti-blood-clotting pills.

The life-saving benefits of blood thinner Xarelto, co-developed with Johnson & Johnson, could alter the treatment of patients who suffer from acute coronary syndrome (ACS), according to experts at the American Heart Association scientific meeting in Orlando, where the data was presented.

While Xarelto patients incurred a significantly higher risk of major haemorrhages, including bleeding in the brain, there was no increase in fatal bleeds.

Researchers in Orlando said the lower death rate trumped the bleeding risk, but some analysts were more cautious.

Bayer shares had edged 0.5 percent lower by 1052 GMT. [They finished the day down 2.2%.]

"The initial commercial potential looks limited, given the increased bleeding risks seen with Xarelto in the trial," Deutsche Bank analysts said in a research note.

"We expect use in ACS to be limited, given the availability of newer, more potent anti-platelet regimes such as AstraZeneca's Brilinta that improve outcomes with less increased bleeding," they said.

Results presented on Sunday showed the new Xarelto pill reduced the risk of death by more than 30 percent in patients who have had an ACS episode, typically a heart attack caused by a blocked coronary artery.

"This will make Xarelto a must-have drug for cardiologists for at least a proportion of their acute coronary syndrome patients," [but what proportion?] UniCredit analysts Craig Maxwell and Andreas Heine said in a note.

The New England Journal of Medicine said in an editorial [#msg-68962549] that the results heralded a "new era" in the prevention of heart attacks in ACS patients, but cautioned that more research into patients at a high risk of bleeding was needed.

The use in ACS patients accounts for about 15 percent of the drug's potential overall market, when measured by treatment days, according to 2009 data posted on Bayer's website.

Its most important intended use is preventing strokes in patients suffering from atrial fibrillation, a type of irregular heartbeat common among the elderly. Earlier this month, Xarelto won U.S. approval for use in this setting.

Xarelto is competing with other new medicines in the multibillion-dollar anti-clotting market, including Bristol-Myers Squibb and Pfizer's apixaban, also known by its brand name Eliquis, which has so far been seen as superior.

Another contender is Pradaxa, sold by privately held German drugmaker Boehringer Ingelheim, which was first to market.

But apixaban/Eliquis failed to meet the main goal of separate, unrelated studies presented in Orlando.

"(The Xarelto study results), combined with the failure of key competitor Eliquis in the prevention of venous clots presented in the same meeting, will in our view drive a significant sentiment swing in favour of Xarelto among cardiologists," UniCredit analysts said.

In a study that compared it to the current standard treatment, apixaban showed a trend toward preventing dangerous blood clots in seriously ill, bed-ridden patients but fell short of achieving a statistically significant result.

Xarelto had also suffered a setback in that setting in April, when surprisingly high bleeding rates were deemed unacceptable for such patients.‹

[urche]

xarelto-Bayer/JNJ

After reading some summaries of the NEJM data, I think you are correct, DEW, that Xarelto has considerable problems that may affect its commercial success, despite the favorable spin in the media today.

The biggest problem I see is that even for the lower 2.5 mg BID dose, the "major bleeding risk" is about 4X that for placebo (2.1% vs 0.6%). There was not a measurable risk of "fatal bleeding". But, from a clinical viewpoint, that makes little difference. Pt's and doctors for reasons that may be partly emotional, partly rational, and partly legal are very afraid of bleeding risk, especially intracranial hemorrhage. We saw this phenomenon with TPA and other thrombolytics.

The bleeding risk would be tolerated, of course, if the efficacy were high enough. But, the absolute survival benefit of treatment with riva was only 9.1 vs 10.7 for placebo or 1.8%. I don't have the statistics background to put forth the numbers needed to treat and harm, but my gut says the all important net clinical benefit may be very small.

There is also a problem now with dosing. Faced with data that even this small dose of Xarelto is associated with 4 fold major bleeding risk, how are we going to view the higher doses (I think it was 20 mg) approved for other indications such as A. fib? This drug has more testing to sort out how to use it, IMO.

By the way, anyone able to post numbers needed to treat for benefit and harm would be much appreciated.

Urche