Eliquis (apixaban)

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The drug: Eliquis (apixaban)
The disease: Atrial fibrillation
The developer: Bristol-Myers Squibb, Pfizer
Peak sales potential: Estimates start around $3.8 billion and rise to $5 billion or more.

Bristol-Myers Squibb ($BMY) and Pfizer ($PFE) have already been stiff-armed twice by the FDA on this program, pushing back the PDUFA date to March 17, 2013. The delays have benefited some major league competition in the field that wrangled approvals earlier--Pradaxa and Xarelto--but analysts still see a big upside if the FDA goes ahead and provides its OK.

Mark Schoenebaum is one of a number of analysts who believe that Eliquis--called apixaban earlier--will grow to dominate the multibillion-dollar market for blood thinners in the U.S. as well as Europe. That's exactly what both companies are hoping for. For Pfizer, an approval will provide a crowning achievement in its push to rehabilitate a discredited R&D effort. And after BMS's setback in hepatitis C, you can believe that there's a big appetite to add another pearl to its string of successes.

The developers have proffered data demonstrating that Eliquis--an oral factor Xa inhibitor--can prevent stroke and embolism in patients with atrial fibrillation. And they're pushing for a European approval as well.

The key to remember here is that there are some 6 million people in Europe and another 6 million in the U.S. who suffer from atrial fibrillation. Add in a 25% chance of developing this condition after the age of 40, and you'll see just how lucrative this franchise can be.

For more:
Pfizer and Bristol's Eliquis marches closer to FDA decision
Xarelto, Pradaxa find reprieve in Eliquis delay
FDA rejects blockbuster Eliquis bid, asks Pfizer, BMS for trial clarification