On occasion, we profile some biosimilar manufacturers with whom our readers may not be as familiar as the big pharma players. In this post, we highlight a San Diego company, named Pfenex (pronounced FEE-nex, as in the city).
Pfenex was founded in 2009, the result of a spin-off from The Dow Chemical Company, whose business was based on its proprietary protein production platform. Called Pfenex Expression TechnologyTM, “it combines an extensive toolbox of expression components with a robotically-enabled high-throughput parallel strain screening technology, delivering unprecedented speed and success in identifying protein production strains capable of producing large amounts of soluble, active product,” according to Pfenex’s website. The company believes that use of this recombinant protein production platform could enable the avoidance of process related intellectual property that challenge other biosimilar manufacturers.
The technology itself was developed in 2001. Patrick Lucy, the Interim Chief Executive Officer, President and Secretary, and Chief Business Officer, has been with the company and its predecessor from the beginning of the platform development. Pfenex is also a founding member of the Biosimilars Council.
Why you may be hearing more about this company: A biosimilar version of ranibizumab (Lucentis®) and a therapeutic equivalent to teriparatide (Forteo®) are lead products for Pfenex. Teriparatide, although a recombinant protein, is being developed via the 505(b)(2) pathway and the pivotal study is ongoing. Ranibizumab has completed a phase 1/2 trial and according to Mr. Lucy, Pfenex “is considering its strategic options” with regard to advancing the product. Both were produced using its Pfenex Expression Technology, and Pfenex is further leveraging its platform for the development of other products. In 2016, Pfenex completed a $181 million multiproduct partnership with Jazz Pharmaceuticals, which includes an option for Jazz to negotiate a license to Pfenex’s pegaspargase (Oncaspar®) biosimilar candidate.
Interestingly, Pfenex is also using its technology to develop a very different drug candidate, Px563L, a novel recombinant protective antigen-based vaccine to protect against anthrax. This is part of a $143.5 million advanced development contract with the Biomedical Advanced Research and Development Authority (BARDA) of the Department of Health and Human Services (HHS).