United Therapeutics Corp. said yesterday that it has licensed the North American rights to market Beraprost, a drug treatment for cardio-vascular disorders which is only available in Japan.
The Silver Spring-based company said that under the agreement with Toray Industries of Japan the companies would jointly pay for human clinical trials in the United States, which are needed before they can seek Food and Drug Administration marketing approval.
The privately held companies would share North American sales royalties if the drug is approved for marketing, said Theresa Bongartz, a spokeswoman for United Therapeutics, founded in 1996 by former executives of drug giant Glaxo Wellcome PLC.
Beraprost is a pill form of prostacyclin, available in the United States only through intravenous infusions.
Martine Rothblatt, chairman and chief executive officer of United Therapeutics, which maintains its research office in Research Triangle, N.C., said the company hopes to gain FDA approval to begin conducting small human clinical trials this year and to launch large scale studies by 2001.
Pub Date: 1/16/99