Date: 2016-08-08
Type of information: Termination of an agreement
Compound: PF582 ( biosimilar candidate to Lucentis® - ranibizumab injection)
Company: Hospira (USA - IL) Pfenex (USA - CA)
Therapeutic area: Ophtalmological diseases
Type agreement: development commercialisation
Action mechanism: biosimilar monoclonal antibody
Disease: wet age-related macular degeneration (wet AMD), diabetic macular edema (DME), visual impairment due to macular edema secondary to retinal vein occlusion (RVO)
Details: * On February 10, 2015, Pfenex, a clinical-stage biotechnology company engaged in the development of biosimilar therapeutics, and Hospira announced that the companies have entered into an agreement to exclusively develop and commercialize for worldwide sales PF582, Pfenex's biosimilar candidate to Genentech's Lucentis® (ranibizumab injection). Pfenex and Hospira will share the Phase 3 equivalence clinical trial costs, and Hospira will be responsible for manufacturing and commercializing the product worldwide. The collaboration will be governed by an Executive Steering Committee consisting of equal representation from Pfenex and Hospira. 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®.The agreement is subject to review under the Hart-Scott-Rodino Antitrust Improvements Act. 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. The agreement also allows for additional future product collaborations. Pfenex's pipeline also include PF530, an interferon beta-1b biosimilar (Betaseron®), PF694, a peg-interferon alpha-2a biosimilar (Pegasys®), PF529, a peg-filgrastim biosimilar (Neulasta®), PF444, a human growth hormone biosimilar (Genotropin®), PF688, certolizumab-pego biosimilar (Cimzia®) and PF-690, a peg-aspargase biosimilar (Oncaspar®).
Financial terms: 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.
Latest news: * On August 8, 2016, Pfenex announced that the company will regain the full rights to PF582, a biosimilar candidate to Lucentis®, following Hospira's strategic review of the current therapeutic focus of its biosimilar pipeline. The company has also announced PF582 phase 1/2 safety and efficacy data. The primary endpoint of the study was safety and tolerability of PF582 compared to that of Lucentis in patients with neovascular age-related macular degeneration.
