Clinical-stage biotechnology firm Pfenex has partnered with Hospira to develop and commercialise PF582, Pfenex’s biosimilar candidate to Genentech’s Lucentis (ranibizumab injection).
PF582 is being developed to treat patients with retinal diseases.
Lucentis forms part of a $6.7bn intraocular anti-vascular endothelial growth factor (VEGF) therapeutic segment and reported global sales of around $4bn in 2014.
Pfenex CEO Bertrand Liang said: "This collaboration further validates the product development strength and capability of Pfenex as we continue to advance our pipeline of biosimilar candidates."
As part of the deal, Pfenex will secure an upfront payment of $51m, once the collaboration receives antitrust approval.
Pfenex will also be eligible to receive a combination of development and sales-based milestone payments up to an additional $291m, over the next five years and beyond.
In addition, the company will receive tiered double-digit royalty on net sales of the product.
Both the firms will share costs of the Phase III equivalence clinical trial, while Hospira will take the responsibility for manufacturing and commercialising the product worldwide.
Hospira senior vice-president and chief scientific officer Sumant Ramachandra said: "We are excited to be entering this collaboration with Pfenex for its biosimilar candidate to Lucentis, which we expect will expand Hospira’s biosimilars pipeline to include a new therapeutic area."
Pfenex is currently carrying out a Phase Ib/IIa clinical trial, where 24 patients were randomised to receive monthly intraocular injections of PF582 or Lucentis for three doses and ongoing patient follow-up for 12 months.
The primary objective of the study is to assess safety and tolerability of PF582, and the secondary objectives include comparative pharmacokinetic (PK) and pharmacodynamic (PD) evaluations to help demonstrate biosimilarity to Lucentis.
Image: Hospira headquarters. Photo: courtesy of Acherubini2020.