France OKs United Therapeutics IV treatment -- Gazette.Net







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This article was corrected Dec. 28, 2010. An explanation follows.

Recovering from the failure of an oral supplement to treat pulmonary arterial hypertension, United Therapeutics has received approval in France for an intravenous treatment.

The firm also has submitted a U.S. application for a standalone oral treatment.

French regulatory agency Agence Francaise de Securite Sanitaire des Produits de Sante has approved IV use of the Silver Spring company’s Remodulin.

Remodulin already is approved in most of Europe and in the U.S. for subcutaneous infusion treatment, or continuous injections just under the skin, according to United Therapeutics information.

United Therapeutics also has Food and Drug Administration approval to use the IV treatment in the U.S., although its website cites the subcutaneous method as preferred because it is less invasive and removes the risk of bloodstream infection and sepsis.

About half of Remodulin’s users take it subcutaneously, but for those who can’t, the IV provides another option, said Andrew Fisher, spokesman for United Therapeutics.

“It’s a fairly significant part of our treatment,” he said.

The French agency’s approval follows a period during which 22 European nations that already had approved subcutaneous Remodulin reviewed and endorsed a final assessment report to allow Remodulin to be administered intravenously.

“This is a pretty big one for them since France is an important market,” said Douglas A. Doerfler, vice chairman of the Maryland Tech Council and CEO of MaxCyte in Gaithersburg.

The approval demonstrates United Therapeutics’ ability to not only be innovative in its approaches but to be “disciplined” in its commercialization, he said.

To execute its commercial efforts on a global scale makes the firm unique among Maryland biotechs, Doerfler said.

“They continue to be a star in the Maryland biotech world,” he said.

“It is with great satisfaction that intravenous use of Remodulin will now be available to [pulmonary arterial hypertension] patients in Europe,” Roger A. Jeffs, president and COO of United Therapeutics, said in a statement, adding the approval “significantly” expands the treatment options for patients using parenteral therapy in Europe.

“We’re very excited about this opportunity for United Therapeutics in France,” said Steve Silverman, executive director of the Montgomery County Department of Economic Development.

“We’re proud to have them being goodwill ambassadors throughout the world and selling life science potential in Montgomery County.”

Earlier this fall, United Therapeutics failed to show statistically significant improvement among patients who received oral treprostinil — which includes the same active ingredient as Remodulin but in a different formulation — in conjunction with other available treatments during Phase 3 clinical trials.

The drug has shown significant improvement when used in monotherapy, however.

United Therapeutics submitted a new drug application to the FDA for oral treprostinil Tuesday, starting a 60-day period of review.

The company reported its profit grew to $84.4 million in the third quarter this year from $39.7 million in the prior-year quarter. Revenues rose to $201.7 million from $168.6 million.

Explanation: This report originally misstated the name of the U.S. Food and Drug Administration.