UPDATE 2-Protalix says FDA seeks more data on Gaucher drug

* Protalix expects to submit more data during Q2

* Says request primarily related to manufacturing process

* Shares down 14 pct in pre-market trade (Adds details, share movement)

Feb 2 (Reuters) - Israeli biotechnology company Protalix Biotherapeutics Inc (PLX.A) said U.S. health regulators have sought additional information on its experimental drug for Gaucher disease, sending its shares down 14 percent.

"The request focused primarily on validation of the manufacturing process in the company's upgraded manufacturing facility," Protalix said in a statement.

The company said the U.S. Food and Drug Administration (FDA) has not requested any additional clinical or preclinical information.

Protalix expects to submit the requested data regarding chemistry, manufacturing and controls to the FDA during the second quarter of 2010.

If approved, the drug would compete with Genzyme Corp's GENZ.O Cerezyme, the only approved treatment for the disease.

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

Shares of the company were down 98 cents at $6.07 in pre-market trade Tuesday. They closed at $7.05 Monday on the American Stock Exchange. (Reporting by Anand Basu in Bangalore; Editing by Anil D'Silva)