SAN DIEGO & LAKE FOREST, Ill.—Biotechnology company Pfenex Inc. and Hospira Inc. have established an agreement for the exclusive development and commercialization of PF582, Pfenex's biosimilar of Genentech's LUCENTIS (ranibizumab injection). Per the terms of the agreement, Hospira will make an upfront payment to Pfenex of $51 million once the collaboration secures antitrust approval. In addition, Pfenex will be eligible over the next five years and beyond to receive a combination of development and sales-based milestone payments worth up to an additional $291 million, as well as tiered double-digit royalties on net sales of the product. The agreement also allows for the possibility of additional future product collaborations.
The two companies will share the costs of the Phase 3 equivalence clinical trials, with Hospira assuming responsibility for manufacturing and commercialization of PF582 worldwide. An executive steering committee, formed of equal representation from both companies, will govern the collaboration. The agreement is subject to regulatory review under the Hart-Scott-Rodino Antitrust Improvements Act.
"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 characterization capabilities," Dr. Sumant Ramachandra, M.D., senior vice president and chief scientific officer at Hospira, said in a press release. "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."
Pfenex is currently investigating PF582 in a Phase 1b/2a clinical trial of 24 patients; the participants have been randomized to receive either monthly intraocular injections of PF582 or LUCENTIS for three doses and ongoing patient follow-up for one year. The primary objective of the trial to to determine the safety and tolerability of PF582, while the secondary objectives consist of comparative pharmacokinetic and pharmacodynamic evaluations to aid in demonstrating the compound's biosimilarity to LUCENTIS.
"We are extremely pleased to announce our collaboration with Hospira, a recognized world leader in biosimilars. This collaboration further validates the product development strength and capability of Pfenex as we continue to advance our pipeline of biosimilar candidates," Bertrand Liang, CEO of Pfenex, commented in a statement regarding the agreement.
This collaboration comes just a few days after Hospira announced, along with Pfizer Inc., a definitive merger agreement pursuant to which Pfizer will acquire Hospira for $90 per share in cash, with a total enterprise value of roughly $17 billion.
SOURCE: Hospira press release
