Takeda Pharmaceutical Company and AMAG Pharmaceuticals, a specialty pharmaceutical company, have mutually agreed to terminate their license, development, and commercialization agreement, which granted Takeda exclusive rights to market ferumoxytol, a drug to treat iron deficiency anemia (IDA) in patients with chronic kidney disease (CKD), in Canada, the European Union (EU), and Switzerland as well as certain other geographic territories. The companies had formed the agreement in March 2010. The drug is marketed as Feraheme in Canada and as Rienso outside of Canada.

Under the termination agreement, AMAG will regain all worldwide development and commercialization rights for Feraheme/Rienso. Takeda will make a payment to AMAG in connection with the termination and will provide certain transition services to AMAG for up to 180 days after the marketing authorization in each territory. In addition, both parties will undertake a transfer of the regulatory files for the product in each respective territory, and Takeda will not participate in any future development or commercialization activities.

Takeda has been commercializing Feraheme in Canada and Riesno in the EU for the treatment of IDA with patients with CKD. In both of these territories, Takeda has submitted applications to expand the product’s current label to include all patients with IDA regardless of the underlying cause. AMAG will be assessing alternative commercialization strategies for Feraheme in Canada and Rienso in the EU based on pending regulatory decisions, which are expected in 2015.

Feraheme received US regulatory approval in June 2009. Ferumoxytol is protected in the US be five issued patents covering the composition and dosage form of the product. Each issued patent is listed in the US Food and Drug Administration’s Orange Book, the last of which expiries in June 2023.

Ferumoxytol received marketing approval in Canada in December 2012, in the EU in June 2013, and in Switzerland in August 2013.

Source: Takeda Pharmaceutical Company