AMAG Pharmaceuticals And Takeda Announce Mutual Termination of Agreement to License, Develop and Commercialize Ferumoxytol in Ex-U.S. Territories, Including Europe

AMAG Pharmaceuticals

and Takeda Pharmaceutical Company Limited (Takeda) announced today that they have entered into an agreement to mutually terminate the March 2010 license, development and commercialization agreement, which granted Takeda exclusive rights to market ferumoxytol in Canada, the European Union (EU) and Switzerland, as well as certain other geographic territories (under the trade name Rienso® outside of Canada where the product's trade name is Feraheme®). Under the terms of 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 transfer 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 Rienso in the EU for the treatment of iron deficiency anemia (IDA) in patients with chronic kidney disease (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 underlying cause. AMAG will be assessing various alternative commercialization strategies for Feraheme in Canada and Rienso in the EU based, in part, on the pending regulatory decisions which are expected in 2015.