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Pfenex announced that it entered into an agreement to partner with Hospira on the development and commercialization of PF582, a biosimilar candidate to Lucentis.
On Feb. 10, 2015, Pfenex, a clinical-stage biotechnology company, announced that it would partner with Hospira to develop and commercialize worldwide sales of PF582. The injectable drug, which is currently in Phase Ib/IIa clinical trials, is a biosimilar candidate to Genentech’s Lucentis (ranibizumab injection).
As part of the agreement, Pfenex will receive an upfront payment of $51 million and an addition $291 million based on milestones set by the companies. The Phase III clinical trial costs will be split between the two companies, however Hospira will be responsible for manufacturing and commercializing the product worldwide. The Phase Ib/IIa trials are being conducted among 24 randomized patients who receive monthly intra-ocular injections of PF582 or Lucentis for three doses, with an ongoing patient evaluation for 12 months. The trials were designed to measure safety and tolerability, with other objectives including pharmacokinetic and pharmacodynamic evaluations to demonstrate its biosimilarity to Lucentis.
This announcement comes only four days after Genentech announced that it had received expanded approval for Lucentis from FDA for the indication of diabetic retinopathy in patients with diabetic macular edema. This announcement also comes less than a week after Pfizer broke the news that it would buy Hospira for $17 billion, citing its biosimilar pipeline as a driving factor in the acquisition.