AMAG Pharmaceuticals And Takeda Announce Mutual Termination Of Agreement

(RTTNews) - AMAG Pharmaceuticals (AMAG) and Takeda Pharmaceutical Company Ltd. (TKPYY.PK, TKPHF.PK) have reached 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 or 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.

As per 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. 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 or IDA in patients with chronic kidney disease or 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.