Hospira, Inc. has acquired worldwide rights to a biogeneric version of filgrastim and an affiliated manufacturing facility from PLIVA Hrvatska in Zagreb, Croatia. Financial terms were not disclosed.
Hospira will now have full global rights to the biogeneric filgrastim that had previously been part of a strategic collaboration between Hospira and PLIVA/Barr, now owned by Teva Pharmaceutical Industries Ltd.
As part of the agreement, Hospira has also acquired process development capabilities. The Croatia site has sufficient capacity to meet Hospira's worldwide filgrastim and pegfilgrastim requirements, along with expansion options for additional biogenerics manufacturing.
"With this agreement, Hospira expands its reach to new markets for filgrastim, and its global manufacturing capacity for pegfilgrastim," said Ron Squarer, senior vice president, Global Marketing and Corporate Development, Hospira. "Hospira is already well-positioned in the biogenerics marketplace, given our internal capabilities, our strategic collaborations and our commercialization experience in Europe. The additional vertical integration this deal brings, as well as the access to broader markets for our products, further demonstrates Hospira's robust commitment to the biogenerics space."
Applications for the approval of filgrastim were filed with the EMEA and Australia's Therapeutic Goods Administration (TGA) in 1Q09. Filgrastim is a granulocyte colony-stimulating factor (G-CSF) used to treat neutropenia.
Hospira's pegfilgrastim would be a biogeneric version of Amgen's Neulasta, also used to treat neutropenia. Hospira is currently working on regulatory submissions in Europe, Asia and the U.S.