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The opportunity for PF708 reaches beyond the US from the fact that Forteo accounted for $289 million of sales in the EU in 2018. In May, the European Medicines Agency (EMA) accepted the Marketing Authorization Application for PF708, which was submitted by Pfenex’s partner Alvogen. If EMA approval is received, PF708 will be authorized for marketing in all 28 member states of the EU.
“Looking ahead, we are confident in the planning that Alvogen has done thus far in preparation for the commercial launch of PF708 and their established sales and marketing teams are excited to bring PF708 to market. To optimize patient and payer impact, we currently expect our commercial partner Alvogen to launch PF708 upon an FDA decision on the therapeutic equivalence rating,” said Pfenex CEO Eef Schimmelpennink.