US FDA stalls Protalix Gaucher drug taliglucerase, calling for more data, but not new trials
USA-based Protalix BioTherapeutics (NYSE Amex: PLX) saw its shares plunge 27% to $6.86 in morning trading last Friday, after the company said that the US Food and Drug Administration issued a Complete Response Letter regarding its New Drug Application for taliglucerase alfa for the treatment of Gaucher disease, under development with global drugs behemoth Pfizer (NYSE: PFE).
Assuming eventual approval, taliglucerase would compete with two already approved Gauchers drugs, Genzyme’s Cerezyme (imiglucerase), global sales of which reached $719.6 million last year, and Ireland-based Shire’s Vpriv (velaglucerase alfa), which was only approved by the FDA in February 2010 and generated sales of $143 million in 2010. Pfizer acquired rights to taliglucerase in an upfront $60 million deal, with Protalix eligible for a further $55 million in milestone payments.
Manufacturing questions raised
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