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news.AMAG Pharmaceuticals and Takeda Pharmaceutical have entered into a license, development and commercialisation agreement related to Feraheme (ferumoxytol) injection for intravenous (IV) use in all therapeutic indications.
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Takeda Pharmaceutical has received an exclusive license to Feraheme for all therapeutic applications in 5 regions, including Europe, Canada, Turkey, the Commonwealth of Independent States and Asia Pacific countries, excluding Japan, China and Taiwan.
AMAG has received a $60m upfront payment and is eligible to receive up to $220m in development and commercial milestones. AMAG is expected to receive tiered, double-digit royalties based on net sales of Feraheme in the licensed territories. The company is expected to execute and fund the global clinical development of Feraheme in all potential therapeutic indications.
Furthermore, AMAG Pharma also is also expected to be initially responsible for the filing of regulatory applications for Feraheme in Europe and Canada, with Takeda responsible for the regulatory filings in all other regions covered by the agreement. Takeda will eventually hold all marketing authorizations in the licensed territories.
Takeda will be responsible for commercializing Feraheme in all regions included in the licensed territories.
Currently, Feraheme is approved in the US for the treatment of iron deficiency anemia (IDA) in adult patients with chronic kidney disease. AMAG plans to submit a marketing authorisation application to the European Medicines Agency (EMA) for Feraheme for the treatment of IDA in adult patients with chronic kidney disease in Europe in mid-2010.
In addition to that, AMAG also plans to initiate a broad global registrational program for Feraheme for the treatment of IDA regardless of the underlying cause in mid-2010.
Brian Pereira, president and CEO of AMAG Pharmaceuticals, said: “One of our primary goals is to expand the reach of Feraheme to patients around the world with iron deficiency anemia. Takeda’s global presence, their pipeline that includes complementary products to Feraheme and their strength in the marketing and commercialization of therapeutics across many specialties where iron deficiency anemia is present makes them the ideal partner for Feraheme.”
Alan MacKenzie, executive vice president of international operations and CEO at Takeda Pharmaceuticals International, said: “This partnership provides an exciting opportunity to combine AMAG’s unique development abilities with Takeda’s global commercialization capabilities. Takeda is poised to maximize Feraheme’s entry into the selected countries following approval.”