UPDATE 1-Protalix's Gaucher drug treatment protocol gets FDA nod

lunedì 17 agosto 2009 14:25

* FDA approves treatment protocol for Gaucher disease drug

* Protalix shares up 30 pct in pre-market trade

Aug 17 (Reuters) - Protalix BioTherapeutics Inc (PLX.A: Quotazione) said U.S. health regulators approved the treatment protocol for the company's experimental drug for Gaucher disease, sending its shares soaring 30 percent.

The biotechnology company was approached by the U.S. Food and Drug Administration last month to consider submitting a treatment protocol that would allow use of its treatment, prGCD, under an expanded access program.

The treatment protocol is designed to allow physicians to treat patients of Gaucher disease with the drug during an expected shortage of the current leading treatment, Cerezyme.

Cerezyme is made by Genzyme Corp GENZ.O, which recently announced that it would shut down its plant in Boston after a virus halted the production of the drug. Shortages of the drug are expected to hit this month.

In Gaucher patients, organs such as the spleen and liver become enlarged due to the lack of the enzyme needed to break down fats.

"We expect to conclude our phase III pivotal study next month and are looking forward to announcing top-line results from this study in October. We anticipate filing an NDA with the FDA by the end of this year," Protalix Chief Executive David Aviezer said in a statement.

Another company developing a new Gaucher drug is Shire Plc (SHP.L: Quotazione) SHPGY.O.

Shares of Protalix were up 30 percent at $7.50 in pre-market trade. They closed at $5.77 Friday on the American Stock Exchange. (Reporting by Esha Dey in Bangalore; Editing by Deepak Kannan)