By Kim Coghill

Washington Editor

The FDA has informed United Therapeutics Corp. that it is not necessary for its new drug application for UT-15, a subcutaneous treatment for pulmonary arterial hypertension, to be reviewed by the Cardiovascular and Renal Advisory Committee, a statement released by the company said.

In early December, Silver Spring, Md.-based UTC was informed that the committee would review the NDA Feb. 9 and analysts were predicting a spring approval. (See BioWorld Today, Dec. 5, 2000.)

But Friday, neither UTC nor the FDA was available to discuss the change in plans. However, Craig West, a biotech analyst with A.G. Edwards & Sons Inc., in St. Louis, said the announcement "is a slightly bullish sign for the drug. Now, that could slice either way - that means either the FDA looks at the NDA and says it is so terrible that we know we are not going to approve it - or they look at and say we are going to approve it."

West said his gut feeling remains that the UT-15 will be approved.

UT-15 is an analogue of prostacyclin, a molecule produced naturally within the body to keep blood vessels healthy. People with pulmonary arterial hypertension have reduced levels of prostacyclin within the blood vessels in their lungs, resulting in dizziness, fainting, diminished exercise ability and potentially right-heart failure.

UTC submitted its NDA for UT-15 Oct. 16 and was granted six-month priority review status.

In early December, UTC's stock plunged 62 percent after the company released anticipated revenues for UT-15 that were much lower than analysts had predicted. (See BioWorld Today, Dec. 5, 2000.)

UTC estimated partial first-year revenues of $10 million to $20 million, far below the $80 million analysts expected. But company officials refused to address the difference, saying they never comment on analysts' predictions.

West said competition from other investigational drugs is one reason UTC's estimates may be lower. Also, he said Phase III data "wasn't as strong as people had hoped."

The UT-15 open-label study includes 500 patients, half of the company's target of 1,000.

In a prepared statement in early December, the company said "the internal goal is to have 1,000 patients on UT-15 by the end of 2001, of which at least 500 would be based in the United States, and twice as many patients by the end of 2002." (See BioWorld Today, Dec. 5, 2000.)

United Therapeutics stock (NASDAQ:UTHR) closed Friday at $15.687, up $1.20.