United Therapeutics pulls Tyvaso application in EU

(Reuters) - United Therapeutics Corp (UTHR.O) said it withdrew the European marketing application for its drug Tyvaso after the European regulator found that two clinical sites were not in compliance with good clinical practices.

The data included in the application is based upon clinical work performed from 2005 to 2007 by United Therapeutics' subsidiary Lung Rx, the company said.

"It poses no (U.S. regulatory) risk at all. We are already approved here. We have demonstrated safety and efficacy," Chief Operating Officer Roger Jeffs said in a conference call.

Tyvaso is an inhaled drug to treat pulmonary arterial hypertension (PAH), high blood pressure in vessels connecting the lungs to the heart, and was approved by the U.S. Food and Drug Administration last July.

"While the lack of a European approval for Tyvaso eliminates a near-term catalyst and revenue opportunity, we continue to view United Therapeutics as an attractive mid-cap biotech growth name," Lazard Capital analyst Terence Flynn wrote in a note to clients.

There were no major objections from the European Medicines Agency (EMA) related to the safety or efficacy of Tyvaso.

The two centers in question account for about 10 percent of the data sample, the company said.

"We tried to convey to the EMA that irrespective of the issues they may have believed occurred at the two centers, the results from the two centers do not in any way change the result. The result holds with or without these two centers," COO Jeffs said.

The company said its revenue growth targets, based on patient numbers in the United States, were unaffected by the withdrawal.

"There is no P&L consequence to us from this decision... We have always looked at revenues from EU as unexpected upside, gravy cream. To this day, European revenues represent only 10 percent to 12 percent of our company's revenues," Chief Executive Martine Rothblatt said.

Tyvaso sales in 2009 was $20.3 million, or 5.5 percent of total revenue.

The company plans to conduct a new study to secure an EU nod but does not expect to start it before the end of this year. The new trial will be conducted within the existing budget for research and development, it said.

United Therapeutics also plans to increase prices for its PAH injection drug Remodulin by 9.6 percent effective March 25 and sees a related revenue boost of $35 million or more in 2010.

Shares of United Therapeutics were trading down 2 percent at $54.88 in late morning trade Friday on Nasdaq. They touched a low of $52.91 earlier in the session.

(Reporting by Jennifer Robin Raj in Bangalore; Editing by Aradhana Aravindan and Unnikrishnan Nair)