Pfenex to pause development activities on biosimilar Lucentis and Neulasta
Along with reporting results for the third quarter last night, Pfenex provided a business update. Pfenex said it has completed a strategic review of PF582 and PF529, biosimilar product candidates to Lucentis and Neulasta, respectively. The strategic review considered timeline for development and cost. While the market opportunities remain attractive, Pfenex has decided to pause development activities on PF582 and PF529 and focus development efforts elsewhere within the product portfolio until strategic partnerships for these candidates are forged. The company continues to engage with potential strategic partners to monetize the assets. Px563L and RPA563, novel anthrax vaccine candidates, are being developed by Pfenex in response to the United States government's unmet demand for increased quantity, stability and dose-sparing regimens of anthrax vaccine. "The development of our anthrax candidates is funded by the U.S. Department of Health and Human Services, through the Biomedical Advanced Research and Development Authority, or BARDA, in accordance with a cost plus fixed fee advanced development contract valued at up to approximately $143.5M. Recently, Pfenex completed a meeting with the FDA, in which the Agency provided clear guidance for the proposed clinical development and licensure plans for post-exposure prophylaxis indication. Ahead of the phase 2 study initiation, Pfenex expects to continue to demonstrate stability of the vaccine candidates and complete manufacturing of the clinical supply. Pfenex expects to initiate the phase 2 study by year-end 2018," the company added.