Protalix races to FDA with Gaucher's drug app

With Pfizer at its back, Israel's Protalix has pushed ahead with an application to market its new treatment for Gaucher's disease. The promising a new therapy could undercut market leader Genzyme as the big biotech struggles to overcome an embarrassing manufacturing snafu. And Protalix has ambitious plans for more regulatory filings in the near future.

"With this submission, Protalix and Pfizer take a significant step forward in making a cost-effective treatment alternative available for Gaucher's disease patients," Protalix President and CEO David Aviezer says in a statement. "Our global plans include submitting additional regulatory applications for taliglucerase alfa in the near term." Protalix earned a $5 million milestone from Pfizer for the submission, part of a $55 million package of regulatory rewards laid out in their partnership deal.

Genzyme's Cerezyme is one of the most expensive drugs on the planet, costing about $200,000 a year to treat 5,700 patients around the world. But that figure is likely to drop as new competitors come on the market. Shire filed for an approval of its new Gaucher's disease drug in September. Both Shire and Protalix are hustling to get approvals as Genzyme deals with the fallout from the sudden closure of its Allston Landing plant in Massachusetts. 

- check out the Protalix release
- here's the report from the Boston Business Journal

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