Protalix Biotherapeutics Inc. (AMEX:PLX; TASE: PLX) announced today that the US Food and Drug Administration (FDA) will respond by February 1, 2012, to the company's resubmission of the New Drug Application (NDA) for its treatment for Gaucher's disease, Uplyso (the taliglucerase alfa). The FDA had demanded more information about the drug in February 2011, and the company resubmitted the application earlier this month.
The FDA did not claim that there were problems with the drug, but that information was missing to complete the approval process. If the FDA again rejects the drug, it will be a massive blow to Protalix, and to its marketing partner in the US< Pfizer Inc. (NYSE: PFE; LSE: PFZ). The marketing contract is worth hundreds of millions of dollars.
Protalix already sells Uplyso in France, Brazil, Israel, and other countries. The drug is sold in the US under a special program for experimental treatments. Protalix has filed for marketing approval of the drug in several countries in Europe and in Australia.
If the FDA approves Uplyso, Protalix will be the third company in the Gaucher's disease market, after Genzyme Corporation and Shire plc (LSE: SHP). Uplyso is cheaper than Shire's Vpriv and Genzyme's Cerezyme, but a marketing strategy based on this fact could hurt the $1.3 billion market.
Protalix had $4.9 million in sales in the first half, 110% more than in the first half of 2010.
Protalix's share price will open at $4.78 on the American Stock Exchange, giving a market cap of $409 million. The share price rose 3% by mid-afternoon on the TASE to NIS 17.47.
Published by Globes [online], Israel business news - www.globes-online.com - on August 17, 2011
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