UPDATE 2-Savient: FDA does not see more trials for gout drug

* Co still sees filing resubmission by early 2010

* Resubmission would be subject to Class 2 review cycle

* Says has cash to fund ops through at least Dec 2010

* Shares up 2 pct (Adds details, analyst comments, stock movement)

By Esha Dey

BANGALORE, Sept 16 (Reuters) - Savient Pharmaceuticals Inc (SVNT.O) said U.S. health regulators do not expect additional trials to be required for its experimental gout drug, which was denied approval in July, and the resubmission of its marketing application could take up to six months for review.

Savient, which met with the Food and Drug Administration (FDA) on Monday, believes that it can still resubmit for marketing approval of the drug, Krystexxa, by early 2010.

The company also said that it has enough cash to fund operations through at least December 2010, compared to its prior view of August 2010.

The company's shares, which were up 5 percent in premarket trade, fell as much as 6 percent early morning. They were trading up 2 percent at $16.17 midday on Nasdaq.

Analysts called Wednesday's news "mildly positive," saying that the company now provided better visibility.

"Everything falls in line with my expectations," Wedbush Morgan Securities analyst Kimberly Lee said.

Savient said its resubmission would be subject to a Class 2 review, which typically means the regulators would review the drug within six months of a filing.

However, Leerink Swann analyst Joseph Schwartz said the company's goal of resubmitting the application by early 2010 was "pretty conservative."

"This meeting suggests that there aren't any additional pieces of information that the FDA requires," he said.

"They have a relatively short list of remaining items which should be done in October. I don't see why they can't resubmit in November or December," he added.

Savient is trying to get the infused drug approved for patients with chronic gout -- a painful type of arthritis -- who do not improve with other treatments or cannot take the alternatives for various reasons.

About 5 million Americans suffer from gout, in which a build up of uric acid causes swollen joints. Of those, about 40,000 to 60,000 see no improvement with other therapies, according to the company.

In a conference call with analysts, the company said it would now look at reviving its efforts to apply for an approval from the European regulators, but refused to specify a timeline.

Earlier, the FDA had declined to approve the drug citing "deficiencies with the chemistry, manufacturing and controls" section of Savient's Biologics License Application. It had also raised an issue about a change made by the company in its proposed process for manufacturing the drug for commercial use.

On Wednesday, the company said the FDA does not expect further clinical trials to be required as the company has now reverted to its original manufacturing process, provided the drug produced now is representative of that used in the late-stage trials.

The FDA also provided additional clarity relating to the steps necessary for Savient's drug substance manufacturer, Bio-Technology General (Israel) Ltd to satisfactorily correct the observations cited by the FDA during its pre-approval inspection of the manufacturing facility.

Bio-Technology General is a unit of Swiss drugmaker Ferring Pharmaceuticals. (Editing by Aradhana Aravindan)