Auryxia differentiation strategy, check. Next, Keryx has to persuade prescribers

Incoming Keryx CEO Greg Madison outside the JP Morgan Healthcare Conference

Keryx Biopharmaceuticals' ($KERX) launch for hyperphosphatemia med Auryxia is officially underway, and the way incoming CEO Greg Madison sees it, the company has reason to be optimistic. While the New York-based company has its rivals--and competitive ones, at that--the drugmaker has what it takes to carve out its own corner of the market, he says.

Keryx is rolling out Auryxia in the shadow of Renvela, a treatment from Sanofi's ($SNY) Genzyme unit that currently dominates the market with about 65% of scripts. In combination with sister oral phosphate binder Renagel, the French drugmaker's treatment pulled in €531 million in U.S. sales in 2013. A host of generic, calcium-based products are also on the scene. But Madison says Auryxia has an edge that all those drugs don't: iron.

As Auryxia works, patients absorb iron, something many dialysis patients need anyway. By using Auryxia over a competing product, dialysis centers can cut out 52% of the extra injectable iron they provide to deficient patients, Madison says--and simultaneously cut down on costs. Medicare pays dialysis centers a flat-rate $240 per session that covers both the session and the injectable drugs used, meaning that if they can use less of those drugs, they can keep the difference.

"Dialysis centers are motivated to provide excellent quality care and do it in the most efficient way possible," Madison told FiercePharmaMarketing earlier this month outside the JP Morgan Healthcare Conference. "They're for-profit organizations that do need to run themselves as a business overall."

In contrast, Genzyme's product doesn't have that added punch, while the absorbable calcium in the generic products can actually be detrimental to patients, Madison said. And that's what Keryx's field force of 60 reps will be telling payers as the launch ramps up.

The company's sales force will be targeting 5,000 out of 8,000 of the country's nephrologists--the "big writers" for hyperphosphatemia, as Madison calls them. Reps will be pushing iron absorption as a selling point with that audience, too, focusing on the fact that reducing the need for IV iron can reduce the risk of overall side effects like anaphylaxis.

All told, according to Madison, the savings per patient per year from using Auryxia over a competitor range on average between $2,000 and $4,000. He's confident those figures will boost his company's new med at a time when patients, providers and payers are taking a closer look at pharmacoeconomics.

"We're trying to bring value across all the different stakeholders," Madison said. "It's good for patients, good for dialysis providers and good for the payer system."

But that iron comes with a caveat. When U.S. regulators approved Auryxia last September, they also slapped on a label warning that the drug could end up triggering iron overload--leaving some analysts wondering whether the label could hold the drug back.

"The expectations were that the label would have an indication for anemia management," FBR Capital Markets analyst Andrew Berens told the Associated Press at the time. "Instead where it appeared was in the warning section, which is kind of strange because it's like turning a benefit into a warning."

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