FDA withholds approval on Protalix Fabry drug


The FDA has asked for additional data, probably relating to the production process of the treatment.

Israeli drug development company Protalix Biotherapeutics Inc. (NYSE:PLX; TASE: PLX) saw its share price fall sharply after reporting that it had received a "Complete Response Letter" from the US Food and Drug Administration (FDA) for its ProCellEx plant cell-based protein expression system pegunigalsidase alfa (PRX 102). Protalix and Italian company Chiesi Farmaceutici are developing pegunigalsidase alfafor the treatment of adult patients with Fabry disease.

After the announcement, Protalix's share price fell 32.59% to $3.93, giving a market cap of $264.6 million, and is down a further 3.31% in after-market trading.

Sources close to the matter say that the problem is not so much the data itself as concern over the production process for the medication and the lack of supervision over the process during the Covid-19 crisis. The FDA had already delayed its decision for three months while it investigated the production plant in France.

A likely scenario is that no more new trials will be needed and that Protalix and Chiesi will be able to get approval for the factory within a year. A less optimistic scenario is that the FDA won't visit the factory until after the Phase III trial is completed, in which case approval might not be gained for another two years.

Fabry is a rare genetic disease in which harmful proteins accumulate in many organs in the body. 

Published by Globes, Israel business news - en.globes.co.il - on April 29, 2021

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