Hospira, Inc, a global specialty pharmaceutical and medication delivery company, announced the acquisition of worldwide rights to a biogeneric version of filgrastim and an affiliated European manufacturing facility from PLIVA Hrvatska d.o.o. (Zagreb, Croatia), a move that will help extend Hospira's reach and vertical integration in biogenerics. financial terms of the agreement were not disclosed.
As a result of the acquisition, 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, the latter two companies now owned by Teva Pharmaceutical Industries Ltd.
As part of the agreement, Hospira has also acquired process development capabilities and a manufacturing plant in Croatia. The site has capacity sufficient to meet Hospira's worldwide filgrastim and pegfilgrastim requirements, along with expansion possibility 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 product approval of filgrastim were filed with the European Medicines Agency (EMEA) and Australia's Therapeutic Goods Administration (TGA) in the first quarter of 2009.
Filgrastim is a granulocyte colony-stimulating factor (G-CSF) used to treat neutropenia, a condition in which the body makes too few infection-fighting white blood cells. The condition is often caused by drugs prescribed for cancer treatment.
Hospira's pegfilgrastim would be a biogeneric version of Amgen's Neulasta, a second-generation G-CSF also used to treat neutropenia. Hospira intends to launch its biogeneric pegfilgrastim in Europe, Asia and the United States prior to the expiry of patents relating to Neulasta, and is conducting the requisite clinical work to support these regulatory submissions. Hospira also intends to register the Croatian plant and an existing Hospira facility in Australia as global sites of manufacture for pegfilgrastim.
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