Pfenex and Hospira, which is in the process of being acquired by Pfizer, are teaming up to develop the former’s biosimilar of Roche and Novartis’ eye blockbuster Lucentis.
Pfenex is currently conducting a Phase Ib/IIa trial where 24 patients have been randomized to receive monthly intraocular injections of its product, PF582, or Lucentis (ranibizumab) for three doses, with ongoing patient follow-up for 12 months. The big-selling vascular endothelial growth factor (VEGF) inhibitor had global sales of around $4 billion in 2014 and is approved in a number of indications, notably diabetic macular oedema (DME) and wet age-related macular degeneration.
Cashwise, Pfenex will receive an upfront fee of $51 million once the collaboration receives antitrust approval, and, over the next five years and beyond, will be eligible for payments up to an additional $291 million, plus tiered double-digit royalties. The firms will share the Phase III equivalence trial costs, and Hospira will be responsible for manufacturing and commercialisation worldwide.
Just last week, the US Food and Drug Administration expanded approval on Lucentis to treat diabetic retinopathy in patients with DME. The drug is sold outside the USA by Novartis.