Pfenex Inc, a clinical-stage biotechnology company engaged in the development of biosimilar therapeutics, and Hospira, Inc., a provider of injectable drugs and infusion technologies and biosimilars, have entered into an agreement to exclusively develop and commercialize for worldwide sales PF582, Pfenex’s biosimilar candidate to Genentech’s Lucentis (ranibizumab injection). 

Under the terms of the collaboration, Pfenex will receive an upfront payment of $51 million once the collaboration receives antitrust approval, and, over the next five years and beyond, will be eligible to receive a combination of development and sales-based milestone payments up to an additional $291 million, and tiered double-digit royalty on net sales of the product. Pfenex and Hospira will share the Phase III equivalence clinical trial costs, and Hospira will be responsible for manufacturing and commercializing the product worldwide. The collaboration will be governed by an Executive Steering Committee consisting of equal representation from Pfenex and Hospira.The agreement also allows for additional future product collaborations.

Pfenex is currently conducting a Phase Ib/IIa clinical trial of the ranibizuma biosimilar. The clinical trial’s primary objective is to evaluate safety and tolerability of PF582, with secondary objectives including comparative pharmacokinetic and pharmacodynamic evaluations to help demonstrate biosimilarity to Lucentis.

Lucentis had estimated global sales of approximately $4 billion in 2014 and is part of the broader $6.7 billion intraocular anti-VEGF (vascular endothelial growth factor) therapeutic segment, according to information from Hospira.

Source: Hospira