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Hospira and Pfenex to collaborate on ranibizumab biosimilar Posted 20/02/2015

US-based injectables specialist Hospira and US biotechnology firm Pfenex announced on 10 February 2015 that they had entered into an agreement to exclusively develop and commercialize for worldwide sales PF582 (ranibizumab), Pfenex’s leading biosimilar candidate.

Pfenex had been looking for investors to raise money to further its biosimilars pipeline [1].

PF582 is a biosimilar of Novartis/Genentech’s age-related vision loss treatment Lucentis (ranibizumab). The monoclonal antibody drug is indicated for the treatment of wet macular degeneration, macular oedema, degenerative myopia, and diabetes complications; all conditions of the eye causing vision loss.

Lucentis had estimated global sales of approximately US$4 billion in 2014 and is part of the broader US$6.7 billion intraocular anti-VEGF (vascular endothelial growth factor) therapeutic segment. The patents on Lucentis expire in Europe in 2022 and in the US in June 2020.

Under the terms of the collaboration, Pfenex will receive an upfront payment of US$51 million once approved, and, over the next five years and beyond, will be eligible for milestone payments up to an additional US$291 million, as well as royalty payments on net sales of the product.

Pfenex and Hospira will share the phase III equivalence clinical trial costs, and Hospira will be responsible for manufacturing and commercializing the product worldwide.

Pfenex is currently conducting 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 clinical trial’s primary objective is to evaluate the safety and tolerability of PF582, with secondary objectives including comparative pharmacokinetics and pharmacodynamics to help demonstrate biosimilarity to Lucentis.

Pfenex is also developing six biosimilars as part of a joint venture with Strides Arcolab subsidiary Aguila Biotech [2] and a biosimilar of arthritis drug Cimzia (certolizumab-pegol) (PF688) on its own [1].

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References
1.   GaBI Online - Generics and Biosimilars Initiative. Pfenex looking for funding for its biosimilars pipeline [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Feb 20]. Available from: www.gabionline.net/Pharma-News/Pfenex-looking-for-funding-for-its-biosimilars-pipeline 
2.  GaBI Online - Generics and Biosimilars Initiative. Agila Biotech and Pfenex make biosimilars deal [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Feb 20]. Available from: www.gabionline.net/Biosimilars/News/Agila-Biotech-and-Pfenex-make-biosimilars-deal 

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Source: EMA, FDA, Hospira, Pfenex

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