Staff Writer

It was a day late - but AMAG Pharmaceuticals Inc. will hardly end up any dollars short.

Aftermarket word Tuesday that the FDA approved AMAG's Feraheme as an iron replacement therapy sent relief through some quarters, though the firm had assured Wall Street that the delay past the Monday decision date was strictly administrative.

Feraheme (ferumoxytol) won clearance for anemia in adults with chronic kidney disease. The recommended dose is an initial 510 mg intravenously, second 510 mg I.V. hit three to eight days later. The same dose may be given again to patients with persistent or recurrent iron deficiency anemia.

"The label is clean as a whistle," Brian J.G. Pereira, president and CEO of AMAG, told BioWorld Today. "We couldn't have asked for more."

Approval of Feraheme ends a roller coaster ride for investors, disappointed in October when the FDA wanted more information about the product, and then cheered the following month after the agency granted a quicker-than-expected review of the new information. (See BioWorld Today, Nov. 14, 2008.)

That quick review, with a late December decision date, did not quite materialize. But AMAG has cause for celebration now, and the Lexington, Mass.-based firm plans to launch the product during the second half of next month, using a commercial team of about 150 people, including a specialized sales force of 80.

"We intend to price it at a premium to existing I.V. irons," Pereira said, and the exact price will be made public at launch. Company officials were expected to discuss the approval in a conference call slated for today.

Feraheme's leg up in the $500 million I.V. iron market (mostly in dialysis-dependent kidney disease) consists of a 17-second infusion time compared to as long as half an hour, at two doses - rather than eight to 10 doses - per week, in a regimen that lasts a week rather than a month.

AMAG will benefit from use in dialysis patients through 2009 especially, since this is the last year of a payment structure that contributes more for higher-cost drugs.

In pre-dialysis patients, Feraheme probably will expand into the market considerably - increasing penetration from 10 percent to 15 percent, according to a Leerink Swann estimate. But the picture could prove even brighter, since erythropoietin-stimulating agents penetrated 50 percent - and many ESA patients also are deficient in iron.

"The first thing you need to do [in treating anemia] is fix iron deficiency," Pereira pointed out, though many patients are treated with ESAs and are not getting iron. Part of AMAG's push will involve educating nephrologists, he added.

Thanks to its dosing benefits, Feraheme could gain further ground in dialysis clinics officially held down by agreements to use Venofer (iron sucrose), the I.V. iron from Fresenius Biotech, of Bad Homburg, Germany, which claims 55 percent of the U.S. market share.

The other I.V. iron product on the market is Ferrlecit (sodium ferric gluconate) from Corona, Calif.-based Watson Pharma Inc.

Pereira said that, despite skepticism from some people, AMAG felt sure about the approval. "What held us up was a few manufacturing issues," he said. "The moment we addressed those, we were confident that approval was in the cards."

Published  July 1, 2009