Md. firm's shares dive 39%

United Therapeutics expects to stop developing Beraprost

October 16, 2001|By Julie Bell | Julie Bell,SUN STAFF

Shares of United Therapeutics Corp. fell nearly 39 percent yesterday afternoon after the company announced that it expects to cease development of its drug Beraprost for peripheral vascular disease after it failed to significantly help patients taking it in a clinical trial.

Shares lost $6.32, to close at $10.04 on the Nasdaq stock market. More than 2.8 million shares traded, nearly 11 times the average daily volume in the last six months.

The Silver Spring company said the late-stage test, which involved 750 patients at 60 sites across the United States, failed to replicate the positive results of a similar trial in Europe. Both were Phase III clinical trials designed to see whether Beraprost reduced the pain of peripheral vascular disease patients when they walked.

Phase III is the third and final stage of human testing required by the Food and Drug Administration before it will consider a drug for the market.

"We are completely surprised by the discrepancy between the results achieved in this study and the significant results achieved by the European study," Michael Wade, the company's associate director of research and development, said in a statement.

Wade said the criteria used to determine whether patients were eligible, and the study's primary goals, were "nearly identical" with the European test that showed Beraprost to be effective.

Peripheral vascular disease, which affects about 6 million people in the United States, involves a painful narrowing of blood vessels in the legs that can lead to leg ulcers and ultimately result in amputation. The disease is associated with a reduced amount of a natural compound in the blood vessels called prostacyclin that is believed to dilate blood vessels when necessary.

Beraprost, a version of prostacyclin that patients take orally, lasts only about 45 minutes in the blood. The company said yesterday that it is evaluating whether to continue development of a sustained-release version of Beraprost, to which it obtained the rights in July 2000. In addition, United Therapeutics said it would continue its Phase III testing of Beraprost as a treatment for pulmonary arterial hypertension, a disease similar to peripheral vascular disease that affects the vessels between the heart and lungs and can be fatal.

United Therapeutics had scheduled Beraprost for peripheral vascular disease to be the second drug it brought to market.

It is awaiting FDA clearance to market its first, Remodulin, a treatment for pulmonary hypertension that is administered via a pump through a needle placed under the skin.

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