Takeda, AMAG Pharmaceuticals agree to terminate ferumoxytol commercialization agreement

The agreement granted Takeda exclusive rights to market ferumoxytol in Canada, EU and Switzerland, as well as certain other geographic territories

As part of the termination deal, AMAG will regain all worldwide development and commercialization rights for the product.

In addition, Takeda will make a payment to AMAG in connection with the termination as well as provide certain transition services to AMAG for up to 180 days after the marketing authorization transfer in each territory.

The two parties will undertake a transfer of the regulatory files for the product in each respective territory, while Takeda will not participate in any future development or commercialization activities.

Ferumoxytol was marketed under the trade name Rienso outside of Canada where the product’s trade name is Feraheme.

The drug was commercialized by Takeda in Canada as Feraheme and in the EU as Rienso to treat iron deficiency anemia (IDA) in patients with chronic kidney disease (CKD).

Takeda has also submitted applications in both of these territories 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 the product in Canada and in the EU based, in part, on the pending regulatory decisions which are expected in 2015.

Image: Takeda Midosuji Building, the head office of Takeda Pharmaceutical Company, in Chuo-ku, Osaka, Japan. Photo: courtesy of J o.