February 11, 2015
By Alex Keown, BioSpace.com Breaking News Staff
SAN DIEGO -- Hospira, Inc. and Pfenex Inc. have entered into a $342 million agreement to develop and market PF582, Pfenex’s “wet” age-related macular degeneration medication similar to Genentech’s Lucentis.
Pfenex (pronounced “Phoenix”) is currently conducting a Phase Ib/IIa clinical trial where 24 patients are receiving monthly eye injections of PF582 for three doses. Those patients will receive ongoing 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 company said in a press release.
Macular degeneration is the leading cause of severe vision loss in people over age 60. The growth of abnormal blood vessels from characterizes the “wet” form of macular degeneration. These blood vessels leak blood and fluid into the retina, causing distortion of vision. The blood vessels eventually leave scar tissue, which can lead to permanent loss of central vision. The more common form of macular degeneration is the “dry” form, however about 10 percent of those cases lead to the “wet” form.
Pfenex, a clinical stage biotechnology firm specializing in biosimilars, and Hospira, one of the leading companies providing injectable medications, will share the Phase III equivalence clinical trial costs, and Hospira will be responsible for manufacturing and commercializing the product worldwide. As part of the agreement, Pfenex will receive an upfront payment of $51 million and recoup another $291 million as part of development and sales-based payments tiered double-digit royalties on sales of the drug over the next five years. . Hospira will manufacture the drug. The agreement between the two companies is subject to review under the Hart-Scott-Rodino Antitrust Improvements Act.
Sumant Ramachandra, chief scientific officer for Hospira, said the collaboration 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,” Ramachandra said.
Genentech ’s Lucentis is a prescription medicine for the treatment of patients with wet age-related macular degeneration (wAMD), macular edema following retinal vein occlusion (RVO), and diabetic macular edema. Last year Lucentis had estimated global sales of approximately $4 billion.
Pfenex currently has nine biosimilar molecules in development. In addition to PF582, a biosimilar candidate to Lucentis, the company is working on PF530, a biosimilar candidate to Betaseron marketed by Bayer AG for the treatment of multiple sclerosis.
Last week Hospira was acquired by Pfizer for $17 billion.
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