AMAG Pharma Guides on Feraheme - Analyst Blog
Recently, AMAG Pharmaceuticals Inc. (AMAG) stated that it expects net revenues between $12 and $13 million from its lead anti-anemia injectable product Feraheme for the fourth quarter of fiscal 2009 (ended December 31).
AMAG had launched the Feraheme (ferumoxytol) injection in the United States on July 13, 2009. It is an intravenous iron replacement therapy to fight anemia in patients with chronic kidney disease (CKD). The drug can be used by patients even if they are undergoing dialysis.
The company further stated that Feraheme has been purchased by more than 1,000 customers to date, approximately 60% of whom have bought the drug on a repeat basis. Management believes that approximately 60% of the demand for Feraheme since its launch has come from patients not undergoing dialysis.
AMAG believes that the total operating expenses incurred in the fourth quarter of 2009 will exceed that recorded in the immediately preceding quarter. The increase is attributable to higher research and development expenses and commercial spending.
The company also provided an update on the developments for Feraheme outside the United States. In Dec. 2009, the company applied for an approval of the product in Canada for treating iron deficiency anemia in CKD patients. The company intends to apply for European approval of the drug for the same indication by mid-2010.
AMAG is currently consulting with commercial partners in the European Union. Recently, 3SBio Inc. (SSRX), AMAG’s partner in China, submitted an application for a registrational trial to the Chinese State Food and Drug Administration for Feraheme for intravenous use.
AMAG has also provided an update on its efforts to expand Feraheme’s label. The company is in active discussions with global regulatory authorities regarding the protocols for the registrational trial of Feraheme for treating iron deficiency anemia irrespective of the underlying cause, and intends to initiate the late-stage study mid-2010.
Furthermore, a mid-stage study for Feraheme in vascular-enhanced magnetic resonance imaging (VE-MRI) in patients with peripheral arterial disease (PAD) is undergoing enrollment.
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