Hospira will team up with Pfenex to exclusively develop and commercialize for worldwide sales its lead product candidate PF582, Pfenex's biosimilar candidate to Genentech's eye treatment Lucentis® (ranibizumab injection), in a deal that could generate up to $342 million for Pfenex.
The deal comes just five days after Hospira said it had agreed to be acquired by Pfizer for about $17 billion, in a deal designed to enhance the pharma giant’s established drug business with Hospira’s expertise in biosimilars as well as injectable drugs and infusion technologies.
Under the collaboration disclosed today, Hospira agreed to pay Pfenex $51 million upfront once the collaboration receives antitrust approval. The agreement is subject to review under the Hart-Scott-Rodino Antitrust Improvements Act.
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 $291 million from Hospira, as well as tiered double-digit royalty 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.
Genentech won that last DR-in-DME indication just on Friday, the first treatment approved in the U.S. for such use, and the fourth indication for Lucentis since it was launched to market in 2006.
The FDA granted Lucentis a Breakthrough Therapy Designation and Priority Review for DR-in-DME based on results from the RISE and RIDE Phase III clinical trials. The trials involved 759 participants who were treated and followed for three years. In the two studies, participants being treated with Lucentis showed significant improvement in the severity of their DR at two years compared to patients who did not receive an injection.
Lucentis generated CHF 1.701 billion (about $1.838 billion) in 2014 sales for Genentech and parent company Roche, up 0.7% from 2013 sales of CHF 1.689 billion ($1.825 billion).
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, as well as 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 study (NCT02121353) has an estimated completion date of June 2015, according to ClinicalTrials.gov.
Pfenex and Hospira have agreed to share the costs of a planned Phase III equivalence clinical trial, 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. The agreement also allows for additional future product collaborations.
“This collaboration further validates the product development strength and capability of Pfenex as we continue to advance our pipeline of biosimilar candidates,” Pfenex CEO Bertrand Liang said in a statement.
Sumant Ramachandra, M.D., Ph.D., Hospira svp and CSO, said the collaboration will leverage Pfenex’s biosimilars development expertise—including its expression technology and differentiated bioanalytical characterization capabilities—with the expectation of expanding Hospira's biosimilars pipeline to include a new therapeutic area.