Armed with EU stroke approval, Pfizer, BMS talk up Eliquis' edge over rivals

Pfizer and Bristol-Myers Squibb finally have the chance to give their new blood thinner a real boost. European regulators approved Eliquis to prevent stroke in patients with atrial fibrillation, giving the drug access to a much larger market. It's the drug's first approval for that use worldwide--and its first big step toward blockbuster status.

While Eliquis won't exactly mint money off this new approval, it could spin some serious gold for Pfizer ($PFE) and Bristol-Myers ($BMY). Millions of patients in Europe have atrial fibrillation, and studies have shown that the prevalence of AF is rising. So, whereas Eliquis brought in just $1 million for Bristol-Myers Squibb during the third quarter, based on its approval for clot prevention in certain surgery patients, the drug really could take off in the AF market.

Indeed, analysts figure it can hit up to $5 billion in peak sales if it wins approval in the U.S. And that makes Eliquis a major new product for Pfizer and Bristol-Myers Squibb, which share sales and profits equally. Both companies have lost patent protection on their previous best-sellers, Lipitor and Plavix. Sales of those meds have plummeted, putting a big drag on overall revenues. While Eliquis won't completely fill the gaps left by those now-generic megablockbusters, it could be a big help.

Eliquis will compete with warfarin, the standard-and-generic treatment it's designed to replace, and with two other warfarin alternatives. Boehringer Ingelheim's Pradaxa has the biggest head start; it won European approval for stroke prevention in AF patients last August. Bayer's Xarelto secured the same indication in December.

But Eliquis has an edge over both of its head-to-head competitors, and you can bet that Pfizer and Bristol-Myers will use it. "Eliquis is the only oral anticoagulant that has demonstrated superior risk reduction versus warfarin in the three important outcomes of stroke and systemic embolism, major bleeding, and all-cause mortality," the companies said in announcing the approval. Pfizer CEO Ian Read touted its "differentiated profile." Sales materials and reps will be beating that drum repeatedly.

In one major trial, Eliquis beat warfarin at preventing strokes, and the Eliquis arm saw fewer bleeding problems. Xarelto only matched warfarin on safety and efficacy. Pradaxa outperformed warfarin in its own supporting trials, but FDA questioned the quality of that data--the study wasn't totally blind--and didn't allow Boehringer to claim superiority to warfarin on its label.

Plus, since Pradaxa's introduction, Boehringer has had to strengthen warnings against its use in kidney patients, after FDA and EMA reviewed reports of hundreds of deaths and even more cases of serious bleeding. Both agencies have continued to back the drug--and pointed out that Pradaxa has been prescribed to millions of patients--but some doctors have grown leery. Unlike warfarin, neither Pradaxa nor any of its warfarin-alternative rivals, has an antidote to stop serious bleeding once it starts. (Boehringer is looking for one.)

Eliquis is still waiting for FDA approval, after a series of delays. In June, the agency surprised analysts--and the companies, no doubt--by putting off approval again, probably till spring 2013.

- get the companies' press release
- see the Reuters news

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