Washington Editor

United Therapeutics Corp. said the General Commission of the French Regulatory Agency had rejected Remodulin due to insufficient demonstration of clinical efficacy.

The company's stock (NASDAQ:UTHR) dropped 4 cents Tuesday to close at $24.15.

Remodulin (treprostinil sodium) is approved in the U.S., Canada and Israel as a treatment for pulmonary arterial hypertension.

When asked why the French rejected the application, Fred Hadeed, chief financial officer for United Therapeutics (UTC), of Silver Spring, Md., told BioWorld Today the company has not received formal, written communication from the French - instead receiving a verbal message - which made it difficult to fully explain the decision.

The company did say it did not expect European approval in the near future.

Nevertheless, Hadeed said there are options for UTC.

"But until we get the report back, it is hard to say much more in terms of the rationale for any decision or what the resulting regulatory approach might be, whether it is an appeal, whether it is supplying additional data, whether it is withdrawing and calling it a day in France, or whether it is moving to another country - we just don't know yet," he said.

UTC's plan, though, was to use France as a "reference nation" for regulatory approval in other countries across Europe. The answer very well could be for UTC to seek approval first in another European country, Hadeed said.

The subcutaneous form of Remodulin, formerly UT-15 and also Uniprost, in May 2002 won FDA approval as a treatment for pulmonary arterial hypertension in patients with New York Heart Association Class II through Class IV symptoms to diminish symptoms associated with exercise. (See BioWorld Today, May 24, 2002.)

In mid-July, UTC said the FDA accepted its investigational new drug application for Remodulin by intravenous delivery.