Thursday, August 21, 2008

AMAG Pharma’s CKD diagnostics on FDA Fast Track

By Mass High Tech Staff

Cambridge biotech AMAG Pharmaceuticals Inc. (Nasdaq: AMAG) has reported its ferumoxytol, a diagnostic tool for arterial disease in patients with chronic kidney disease, has been given Fast Track designation from the U.S. Food and Drug Administration.

Fast Track is an FDA status that speeds development of certain products that have potential to treat “a serious or life-threatening condition.”

Ferumoxytol is an intravenous iron replacement therapeutic agent that treats iron deficiency anemia. It also works with Vascular-Enhanced Magnetic Resonance Imaging to detect arterial problems, such as leg pain linked to walking, for people diagnosed with or suspected to have chronic kidney disease.

In May, a partnership between AMAG Pharmaceuticals and 3SBio Inc. of China will allow the Chinese biotechnology company to develop and commercialize ferumoxytol in China. Under terms of the agreement, 3SBio (Nasdaq: SSRX) will pay AMAG Pharma $1 million up front with potential for further payments if the therapeutic agent meets regulations for use with chronic kidney disease. AMAG Pharma may also receive royalties of up to 25 percent from sales of ferumoxytol.

The company is planning to move its headquarters this fall to Lexington, while using the Cambridge facility for manufacturing and research. AMAG Pharmaceuticals reported a 2007 net loss of $33 million on revenue of $2.25 million, and employs 88 workers.