Hospira and Pfenex link up to develop Lucentis biosimilar


Pfenex will receive US$51m upfront once the collaboration receives antitrust approval

Hospira, a US injectables drug specialist, is teaming up with Pfenex, a clinical-stage biotechnology company, to develop and commercialise PF582, Pfenex's biosimilar version of Genentech's eye treatment Lucentis (ranibizumab injection).

The deal follows hot on the heels of the announcement that Hospira has agreed to be acquired by Pfizer for about US$17bn.

Under the terms of this new agreement, Hospira will pay $51m upfront to Pfenex once the collaboration receives antitrust approval.

Over the next five years and beyond, the companies said, Pfenex will be eligible to receive a combination of development and sales-based milestone payments up to an additional $291m, and tiered double-digit royalties on net sales of the Lucentis biosimilar.

Lucentis is a vascular endothelial growth factor (VEGF) inhibitor indicated for the treatment of patients with neovascular (wet) age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME), and diabetic retinopathy (DR) in patients with DME.

Earlier this month, Genentech received approval from the US FDA for Lucentis for the treatment of diabetic retinopathy in people with diabetic macular edema (DME).

Hospira will pay $51m upfront to Pfenex once the collaboration receives antitrust approval

Pfenex is currently conducting a Phase 1b/2a clinical trial of PF582 where 24 patients have been randomised to receive monthly intraocular injections of the drug or Lucentis for three 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.

Hospira and Pfenex will share the costs of a Phase III equivalence clinical trial, and Hospira will be responsible for manufacturing and commercialising the product worldwide.

The agreement also allows for additional future product collaborations.

'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,' said Sumant Ramachandra, SVP, 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.'

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Lucentis generated global sales of approximately $4bn in 2014 and is part of the broader $6.7bn intraocular anti-VEGF (vascular endothelial growth factor) therapeutic segment.