San Diego, California based Pfenex has traditionally provided its proprietary protein expression platform as a service with around 35% of its 2013 revenues coming from an anthrax development contract with the US Government's Biomedical Advanced Research and Development Authority (BARDA), and a further 18% from a process development contract with federal funded Leidos Holdings.
However, Pfenex is now focusing on its own biosimilar pipeline, after raising $52.6m (€40m) in an initial public offering (IPO) which closed in July, according to a quarterly report form 10-Q filed with the SEC last week.
“Our historical revenue has been primarily derived from monetizing our Pfēnex Expression Technology through collaboration agreements, service agreements, government contracts and reagent protein product sales,” the firm said in the filing.
However, “as we continue to focus our business on the development of our product pipeline, we anticipate allocating fewer resources to certain aspects of our protein production activities that currently generate our revenue.”
For the first half 2014, the firm reported total revenues of $5.8m – up slightly on the same period 2013 – and attributed to its government contract and a one-time reagent protein sale, however Pfenex expects revenue related to its protein production services to decline in the near-term as its shifts its resources to developing biosimilars.
Pfenex Expression Tech
Pfenex’s lead candidate is PF582, a version of Genentech’s monoclonal antibody drug Lucentis (ranibizumab) for the treatment of patients with retinal diseases, currently in Phase Ib/IIa trials. The firm is also developing a biosimilar to Bayer’s Betaseron (interferon beta-1b), as well as developing a further six products in a joint venture with Agila-subsidiary, Strides Arcolab.
“Our biosimilar product candidate selection strategy is to focus on products with large addressable markets,” the firm said in the filing, “which will be free of intellectual property barriers during our projected approval timelines, and for which our Pfēnex Expression Technology enables efficient and large scale manufacturing.”
The platform is based on the automated high-throughput screening of large libraries of genetically engineered Pseudonamas fluorescens bacterial expression strains and, according to the company, can generate high quality, high titre proteins in less than nine weeks compared to – on average – a year.
“Traditional techniques for protein production employ a trial and error approach to production organism, or strain, selection and process optimization, which is inherently inefficient and typically produces suboptimal results,” the company added. “This historically inefficient process provides barriers to create or replicate complex proteins, adds significant time to market and results in the high cost of goods.”
And Biopharma-Reporter will be delving deeper into the issues affecting biosimilars with a free virtual event on September 26. Join four industry experts as they discuss the development, manufacture and sale of such products in a 60 minute seminar hosted by our Editor-in-Chief Gareth Macdonald. Click here for more details...