Pfenex filed a registration statement with the US Securities and Exchange Commission for a proposed initial public offering of its common stock on 6 June 2014.

Pfenex is focussed on biosimilars, and its lead product is PF582, a biosimilar of Roche’s Lucentis (ranibizumab). The monoclonal antibody drug is indicated for the treatment of patients with wet age-related macular degeneration (AMD), macular oedema following retinal vein occlusion (RVO) and diabetic macular oedema (DME); all conditions of the eye causing vision loss.

The company’s biosimilars pipeline also includes six biosimilars that are being developed as part of a joint venture with Strides Arcolab subsidiary Aguila Biotech [1]. These include biosimilars of multiple sclerosis treatment Betaseron (interferon beta-1b) (PF530), chronic hepatitis B/C treatment Pegasys (peg-interferon alpha-2a) (PF694), peg-interferon beta (PF756), neutropenia treatment Neulasta (peg-filgrastim) (PF529), human growth hormone (PF444) and leukaemia treatment Oncaspar (peg-aspargase) (PF690). Pfenex is also developing a biosimilar of arthritis drug Cimzia (certolizumab-pegol) (PF688) on its own.

Pfenex intends to use approximately US$40 million of the funds raised from the sale of shares in the company to fund clinical development of PF582, including approximately US$5 million for the ongoing phase Ib/IIa trial and approximately US$35 million for the planned phase III trial. The company expects to start the phase III trial of PF582 in mid-2015, with data expected in 2017. The patent on Lucentis only expires in 2019, giving Pfenex some time yet to work on its biosimilar.

Pfenex will also use approximately US$5 million to fund Pfenex’s share of the planned phase III clinical development of PF530, which it expects to start in the second half of 2014.

Any remaining cash will be used to fund the research and development of other products, including PF694, for which it expects to start a phase I trial in the second half of 2015.

Related article
Biosimilars developments during 2013

Reference
1. GaBI Online - Generics and Biosimilars Initiative. Agila Biotech and Pfenex make biosimilars dealIndia [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Jun 27]. Available from: www.gabionline.net/Biosimilars/News/Agila-Biotech-and-Pfenex-make-biosimilars-deal

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