Clal Finance believes that Protalix Biotherapeutics Inc. (AMEX:PLX; TASE: PLX) has a 70% chance of obtaining US Food and Drug Administration (FDA) approval for its treatment for Gaucher's disease on May 1, and that the approval will be an important milestone for the company and its core technology.
"Following FDA approval, we expect marketing approval for the drug in Europe in the second quarter, and progress in talks with the Brazilian health authorities," says Clal Finance biotech advisor Yoav Keidar.
Protalix is due to obtain FDA approval for Uplyso (taliglucerase alfa), its treatment for Gaucher's disease, in May. In February, the company announced additional data from the extension study of the drug on patients not previously treated. The trial met all its endpoints.
Protalix is also waiting for a response from Brazil's National Health Surveillance Agency (ANVISA) about an agreement worth hundreds of millions of dollars to supply Uplyso to the country. A decision will probably be made after the response from the FDA.
Despite the optimism, Keidar cautions that delays in the FDA approval, which was originally due in February, has resulted in Protalix facing a more complex market for Gaucher's disease. "Delay in approval of the drug and the entry of additional competitors into the market (Genzyme and Shire Pharmaceuticals plc (LSE: SHP)) increase pressure on the company," he says.
The share price rose 4.2% in morning trading on the TASE today to NIS 20.92.
Published by Globes [online], Israel business news - www.globes-online.com - on March 5, 2012
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