Lonquex lipegfilgrastim regulatory update

Amgen Inc. (NASDAQ:AMGN, Thousand Oaks, Calif.) said Teva notified it that the generics company withdrew a BLA from FDA for Lonquex lipegfilgrastim to prevent chemotherapy-induced neutropenia. Amgen said that as a result of the withdrawal it agreed to dismiss a patent infringement suit against Teva filed in the U.S. District Court for the District of New Jersey in August. Teva submitted the BLA last December. The glyco-pegylated recombinant human G-CSF ( CSF3) is approved in Europe to prevent chemotherapy-induced neutropenia and to reduce the duration of neutropenia and the incidence of febrile neutropenia in adults treated with cytotoxic chemotherapy for malignancy, excluding chronic myelogenous leukemia (CML) and myelodysplastic syndromes (MDS). Teva gained Lonquex through its 2010 acquisition of ratiopharm GmbH (see BioCentury, Aug. 16, 2010). ...