Xarelto Scores Again In Huge Heart Trial

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Includes: BAYRY, BMY, JNJ, PFE
by: EP Vantage

With Bristol-Myers Squibb (NYSE:BMY) and Pfizer (NYSE:PFE) throwing everything they’ve got behind Eliquis, Bayer (OTCPK:BAYRY) and Johnson & Johnson (NYSE:JNJ) need to keep up the pressure with Xarelto. These efforts should be helped by success in a huge trial in patients with certain types of artery disease, which has been stopped early for efficacy.

This could open up another big market for the blood thinner, and Bayer shares climbed 2% today on hopes that prospects for its biggest blockbuster just got brighter; the company already projects €5bn ($5.3bn) in peak sales. However, caution is warranted ahead of full data; the partners know full well that apparent clinical success does not always translate into label expansion.

This is exactly what happened the last time they attempted to broaden Xarelto’s patient population, into patients with acute coronary syndrome. Representing a very sick and fragile population this was always a high risk gamble, and it only paid off in Europe (Xarelto knockback shows ACS a troublesome category, February 17, 2014)

Helped by a broader label in the markets that Bayer controls, Xarelto continues to dominate the novel oral anti-coagulant space in Europe. In the US, however, Eliquis has been catching up. A look at how consensus forecasts have shifted over the last 12 months makes this clear.

Shifting outlooks

Product

Company

2016 sales ($bn)

2020e sales ($bn)

12 mth change in 2020 forecast ($m)

Eliquis

Bristol-Myers Squibb

3.34

6.15

1,896

Xarelto*

Bayer

2.60

4.07

138

Xarelto**

Johnson & Johnson

2.29

3.12

76

*Ex-US

**US

Source:EvaluatePharma

These agents all represent a trade-off between clot prevention and bleeding risk, and on this Eliquis arguably has the stronger profile in its biggest approved indication – stroke prevention in atrial fibrillation. Uptake was initially held back by its third-to-market position and twice-a-day dosing, versus once-a-day for Xarelto, but these shackles have now been thrown off.

As the market leader in the US and a real contender in Europe, the threat that Eliquis has long posed is now very real. Thus a label expansion would be a big boost for the Xarelto partners.

Pointing the way

The Compass study sought to prove that Xarelto could lower the risk of major adverse cardiac events in patients with coronary or peripheral artery disease. This represents a substantial market – according to J&J’s numbers, around 27 million Americans suffer from the conditions.

The study enrolled 27,401 patients from across the globe, who were randomized into one of three arms: low dose Xarelto plus low dose aspirin, high dose Xarelto alone, or high dose aspirin alone.

The trial, which was expected to read out early next year, was stopped after reaching its pre-specified criteria for superiority. It is not yet clear which Xarelto arm proved superior to aspirin, or the extent of the benefit.

These details will be crucial to assessing how big this new opportunity could be – with aspirin cheap it is clear that payers will push back unless a substantial benefit can be shown, with an acceptable bleeding risk. Currently many of these patients are treated with clopidogrel or similar agents, and again these are off patent now so comparisons will need to be made. Full data, due later this year at a medical meeting, will be closely scrutinized.

Bayer’s most recent €5bn peak sales projection for Xarelto included new indications, albeit risk adjusted. Analysts at Bryan Garnier commented today that Compass was one of the higher risk trials, and its success could add at least a billion in projected sales.

As the most important growth driver for the German conglomerate’s pharma business, this would be incredibly helpful new revenue. Particularly as the patent clock is ticking: both drugs probably have only six or seven years of protection left for them.

These agents continue to represent huge investments for their respective developers, and time to make that back is running out.

Trial

ID

Compass

NCT01776424

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