- The company reported an increase in U.S. Feraheme net product sales, driven by increased utilization of Feraheme for the treatment of iron deficiency anemia (IDA) in chronic kidney disease (CKD) patients. Total Feraheme provider demand for 2012 was approximately 110,000 grams, representing a 17% increase in provider demand over 2011. Feraheme provider demand for the fourth quarter of 2012 was approximately 27,500 grams, approximately 14% higher than the fourth quarter of 2011. 1
- The company made significant progress expanding the geographic reach of ferumoxytol, with approvals for use in adult IDA patients with CKD in the European Union (EU), Canada and Switzerland. Takeda has commercial rights to ferumoxytol in these regions, where they launched commercially in the fourth quarter of 2012. In the EU and Switzerland, Takeda launched under the trade name Rienso®; in Canada, Takeda launched under the trade name Feraheme. During 2012, AMAG received $33 million in milestone payments from Takeda related to the approvals and launches of Feraheme/Rienso in Europe and Canada.
- AMAG also made meaningful progress in its efforts to expand the label for Feraheme. The company completed a 1,400 patient, phase III registration program for ferumoxytol in adult IDA patients, regardless of the underlying cause of their anemia. The program was comprised of two phase III trials, both of which achieved their respective primary and secondary endpoints (with high statistical significance). AMAG submitted a supplemental new drug application (sNDA) with the U.S. Food and Drug Administration (FDA) in December 2012 seeking to expand the indication for Feraheme beyond the current CKD indication to include all adult patients with IDA who have failed or otherwise cannot take oral iron therapy.
AMAG Announces Fourth Quarter And Year End 2012 Financial Results
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