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

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.

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 3 equivalence clinical trial costs, and Hospira will be responsible for manufacturing and commercialising 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.

"We are extremely pleased to announce our collaboration with Hospira, a recognized world leader in biosimilars. This collaboration further validates the product development strength and capability of Pfenex as we continue to advance our pipeline of biosimilar candidates," said Bertrand Liang, chief executive officer, Pfenex Inc.

Pfenex is currently conducting a Phase 1b/2a clinical trial where 24 patients have been randomized to receive monthly intraocular injections of PF582 or Lucentis for 3 doses and ongoing patient follow-up for 12 months. The clinical trial's primary objective is to evaluate safety and tolerability of PF582, with secondary objectives including comparative pharmacokinetic (PK) and pharmacodynamic (PD) evaluations to help demonstrate biosimilarity to Lucentis.

"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 has established expertise in the development of biosimilars, leveraging its proprietary expression technology together with differentiated bioanalytical characterisation capabilities," says Sumant Ramachandra, MD, senior vice president, chief scientific officer, Hospira. "We look forward to working closely with the Pfenex team to offer patients, physicians and healthcare systems a more affordable treatment option for retinal diseases."

The agreement is subject to review under the Hart-Scott-Rodino Antitrust Improvements Act.