The most recent trial compared ferumoxytol, an intravenous iron replacement therapeutic, to iron taken orally in anemic patients with chronic kidney disease (CKD) who are on hemodialysis. Iron is required for the production of red blood cells, a deficiency in which leads to anemia. Ferumoxytol raised the amount of hemoglobin -- an indirect measure of iron levels -- in the patients significantly more than oral administration of iron, resulting in the trial meeting its primary endpoint.
Oral iron can have some complications, including gastrointestinal side effects, which weren't seen in the patients who received ferumoxytol. Overall, there were fewer drug-related adverse events in the ferumoxytol group.
This was the fourth -- and hopefully final -- phase 3 clinical trial for ferumoxytol. The previous clinical trials looked at both dialysis-dependent and non-dialysis-dependent CKD patients, so the company will be able to ask for marketing approval for both types of patients, which will increase the potential market for the drug.
The company plans to submit all the clinical trial data to the FDA in a New Drug Application in the fourth quarter of this year. That would mean it would get a response from the FDA next summer and could possibly have the product on the market by the end of next year.
Advanced Magnetics hasn't always been a biopharmaceutical company. In fact, its two marketed products -- Feridex I.V., which it markets with Bayer
AMAG Pharmaceuticals had $146 million in the bank at the end of the first quarter. But it should report a substantially larger number when it announces earnings this afternoon, since it made a public stock offering in May. With a burn rate of just $10 million a quarter, which should go down now that clinical trials are through, AMAG should have no problems making it until the FDA makes its decision next year. Whether its sales force can compete with other IV iron injectables from Watson Pharmaceuticals
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