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April 6, 2010
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Recently, AMAG Pharmaceuticals Inc. (AMAG) and Japan-based Takeda Pharmaceutical Co. Ltd. entered into a license, development and commercialization deal related to AMAG’s Feraheme (ferumoxytol) injection for intravenous (IV) use across all potential indications for the drug.
Feraheme is an intravenous iron-replacement therapy for fighting anemia in patients with chronic kidney disease (CKD). The drug can be used by patients irrespective of dialysis.
The deal, potentially worth $280 million, will grant Takeda rights to sell its anemia drug in some overseas markets. Specifically, the deal provides Takeda the rights to market Feraheme in Europe, the Commonwealth of Independent States, Canada, Turkey, and the Asia-Pacific region apart from China, Japan, and Taiwan.
Under the terms of the agreement, AMAG will receive an upfront payment of $60 million. Furthermore, the Massachusetts-based company will be eligible to receive up to $220 million in the event of Feraheme advancing through clinical development and regulatory hurdles. Additionally, AMAG will get tiered, double-digit royalties based on the net sales of the drug in the licensed territories.
The agreement further states that AMAG will be responsible for the clinical development of Feraheme. The company will handle regulatory filings in Europe and Canada while regulatory filings in the other countries covered by the deal will be handled by Takeda.
We remind investors that the US Food and Drug Administration (FDA) had granted marketing approval to Feraheme injection in 2009 for treating iron deficiency anemia (IDA) in adult patients suffering from CKD. AMAG plans to apply for marketing approval of the drug for the same indication in Europe in 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 registration trial to the Chinese State Food and Drug Administration for Feraheme for intravenous use.
AMAG is also making efforts to expand Feraheme’s label. The company is in active discussions with global regulatory authorities regarding the protocols for the registration trial of Feraheme for treating IDA irrespective of the underlying cause and intends to initiate the late-stage study mid-2010.
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