Amag Pharmaceuticals Inc said its marketing partner in Switzerland, Takeda Pharmaceutical Co Ltd, is recalling a batch of Amag's anemia drug, Rienso, because of a death and several cases of hypersensitivity.
Amag shares were down about 5 percent at $23.75 in after-market trading on Tuesday.
"The batch was only distributed to and sold in Switzerland and the recall is limited to the specific batch and specifically Switzerland," Lexington, Massachusetts-based Amag said in a regulatory filing on Tuesday. (r.reuters.com/fek38t)
Amag and Japan-based Takeda are investigating the specific batch and gathering data on the adverse events.
New batches of Rienso may be introduced into the Swiss market depending on the approval of the Swiss health regulator, Swissmedic, Amag said.
Rienso is marketed under the name of Feraheme in the United States and Canada. While Amag markets the drug in the U.S., Takeda owns the distribution rights to it in Canada, European Union and Switzerland.
The drug, which is approved to treat iron deficiency anemia in chronic kidney disease patients, received Swiss marketing approval in August 2012.
Amag aims to increase the patient base for the drug and is planning to seek approval for Feraheme to treat anemia in patients, regardless of the underlying cause.
In a second late-stage study conducted to support an application for the wider indication, the company reported three deaths, of which two were in the Feraheme-controlled group, but none related to the drug.
(Reporting by Pallavi Ail in Bangalore; Editing by Joyjeet Das)