Silver Spring firm moves to testing of its cancer drug

United Therapeutics Corp. yesterday said it moved one step closer to federal government approval for its ovarian cancer drug, OvaRex.

The Silver Spring biotechnology company, which has reported solid sales growth for its only marketed drug, Remodulin, said it reached its goal of enrolling 177 patients for one of two patient studies for OvaRex.

“This doesn’t mean the drug works any better or worse, but it is a nice milestone,” said company spokesman Andrew Fisher.

United Therapeutics has no timetable for when the studies will be completed or when it will receive a final decision from the Food and Drug Administration, Mr. Fisher said.

The announcement comes a month after the company’s shares on the Nasdaq Stock Market reached a record high of $77.82, three days after United Therapeutics released its latest earnings report. Company shares fell 55 cents yesterday to close at $70.34.

Net income for the company’s third quarter, ended Sept. 30, more than doubled to $15.76 million (61 cents per diluted share) from $6.26 million (27 cents) a year earlier. Fully diluted earnings include the value of convertible warrants and stock options.

Revenue jumped 65 percent to $33 million from $19.9 million in the 2004 quarter.

United Therapeutics has an undisclosed number of drugs in development, but OvaRex is the closest to getting FDA approval, Mr. Fisher said.

But analysts yesterday were more interested in developments for Remodulin, which treats rare lung disorder pulmonary arterial hypertension.

OvaRex “is a wait-and-see product,” said analyst Gil Aharon, estimating that the drug’s tests would take another two years to produce results.

Mr. Aharon, with Toronto investment firm Infinium Capital Corp., said he rated United Therapeutics shares “outperform,” based on the sales strength of Remodulin.

Mr. Aharon does not own any company stock, but Infinium is seeking business with United Therapeutics.

Remodulin is sold through an injection administered just under a patient’s skin or via a newer intravenous (IV) version, which is injected directly into a patient’s vein. United Therapeutics also is developing an oral and inhaled version of the drug.

The IV treatment has drawn some patients away from Flolan, an intravenous treatment for the same disorder by GlaxoSmithKline.

Joseph Schwartz, an analyst with Boston investment bank Leerink Swann & Co., said doctors might need more clinical data before switching patients to Remodulin.

New therapies, such as generic versions of Flolan that could appear by 2007, also could hurt Remodulin sales, said Mr. Schwartz, who advised investors to hold their United Therapeutics shares.

Mr. Schwartz does not own any United Therapeutics stock, but Leerink Swann has a business relationship with the company.