Pfenex, Hospira to develop and commercialize proposed biosimilar of Lucentis

PF582 is Pfenex’s biosimilar candidate to Genentech’s Lucentis (ranibizumab injection).

As part of the deal, Pfenex will receive an upfront payment of $51m once the collaboration receives antitrust approval.

Over the next five years and beyond, the company will also be eligible to receive a combination of development and sales-based milestone payments up to an additional $291m, and tiered double-digit royalty on net sales of the product.

The two firms will share the Phase III equivalence clinical trial costs, while Hospira will be responsible for manufacturing and commercializing the product across the world.

The collaboration will be governed by an Executive Steering Committee consisting of equal representation from both the firms.

Pfenex chief executive officer Bertrand Liang said: "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."

Currently, Pfenex is carrying out a Phase Ib/IIa clinical trial where 24 patients have been randomized to receive monthly intraocular injections of PF582 or Lucentis for three doses and ongoing patient follow-up for 12 months.

The trial’s primary objective is to evaluate safety and tolerability of PF582, while secondary objectives include comparative pharmacokinetic (PK) and pharmacodynamic (PD) evaluations to help demonstrate biosimilarity to Lucentis.