Eliquis back on track with European endorsement

The data issues that had held up Eliquis in the US did not trouble the blood thinner in Europe. The European Medicines Agency’s human drugs committee has recommended approval of the Bristol-Myers Squibb and Pfizer factor Xa inhibitor in the key stroke prevention indication, bringing the two companies closer to a big launch of an important growth driver.

With more than half of all sales expected in the US market, getting approval in the world’s largest drug market will be crucial to the product's ability to live up to sky-high expectations. That the EMA committee did not have the same reservations should probably be taken as a sign that the FDA’s questions are fairly minor, and that Eliquis is back on track.

Needed validation

The FDA’s surprise complete response letter last June raised questions about data management and verification from the Aristotle trial against warfarin, in which the new drug showed that it was as good as warfarin at preventing strokes for patients with atrial fibrillation while resulting in significantly fewer bleeding episodes (Eliquis FDA setback turns up the heat on Pfizer and Bristol-Myers Squibb, June 25, 2012). It could be mid-2013 before the drug hits the US market in stroke prevention, making it the last of the new generation of blood thinners to be launched.

The delay will certainly sacrifice some momentum to Boehringer Ingelheim’s Pradaxa and Bayer and Johnson & Johnson’s Xarelto – 2016 forecasts have fallen back by $700m since the beginning of the year, and now stand at $2.8bn. EvaluatePharma forecasts sales will reach $4.2bn in 2018. US sales account for an estimated $2.5bn of the worldwide total.

With the delay in the US, it must come as some relief to get some validation in another jurisdiction – not to mention begin to unlock the revenue stream that Eliquis represents. The anticoagulant is Bristol-Myers Squibb’s biggest growth driver, and for Pfizer, the $2.17bn in cost-sharing alliance revenue it is forecast to collect in 2018 exceeds all its wholly owned growth drivers except vaccine Prevnar 13.

As both companies are reeling from major patent expiries – Lipitor for Pfizer and Plavix for Bristol-Myers – they are keen to generate new growth, and Eliquis is key to that strategy.

Even so, the space is not looking quite like the jackpot once thought. Payer preference and physician familiarity has kept warfarin alive for a bit, helped along by bleeding worries with Pradaxa and Xarelto’s failure to show any efficacy benefit and only a limited safety advantage (Warfarin proves resilient against oral blood thinners, August 21, 2012).

Blessed life

A drug that has experienced less difficulty with global regulators is Regeneron Pharmaceuticals' and Bayer’s Eylea, which also received EMA backing. The injected treatment for wet age-related macular degeneration has seemingly breezed through its key approval catalysts and has seen its outlook steadily improve, with a 2018 forecast that now stands at $2.95bn.

Analysts for Bayer, which owns ex-US co-promotion rights with Regeneron, have been less optimistic, with the German group forecast to earn $876m in sales in 2018. This is a sign that it will win less sales from its main competitor, Novartis’s Lucentis, which is under much stricter price caps outside the US.

Another win will do little to discourage the overall bullish view of Eylea, which has used its dosing advantage to turn the maculopathy space into a fiercely competitive one. On the other hand, with Eliquis, a European win in its biggest indication will have analysts and investors feeling a little more confident that it can indeed live up to expectations.

To contact the writer of this story email Jonathan Gardner in London at [email protected]

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