New Medicine for Diet-Drug Related Heart-Lung Disease To Enter Clinical Trials in North America
TOKYO, and SILVER SPRING, Md., Jan. 15 /PRNewswire/ -- United Therapeutics Corporation ("United Therapeutics"), a US-based specialized pharmaceutical company and Toray Industries of Japan ("Toray"), a major drug discovery and manufacturing company, announced today their agreement to cooperatively test in North America a new drug that has been shown to be successful in Japan in treating certain cardio-vascular disorders. The new drug, called Beraprost, is usually taken 3-4 times daily for the treatment of pulmonary vascular disease and peripheral vascular disease.
"We are very honored to have been selected by Toray as their licensee for North America," said Martine Rothblatt, Chairman & CEO of United Therapeutics. "We are committed to completing the proper dosing studies called Phase II trials during 1999 and the large scale placebo-controlled studies called Phase III trials by 2001. If successful, many thousands of North American patients should be able to benefit from Beraprost soon thereafter, subject to FDA approval."
"We are pleased to have the opportunity to work closely with United Therapeutics," said Kiyoteru Wakasugi, managing director of Toray Industries. "We are impressed with their leadership in the field of pulmonary vascular disease. Toray acquired UT's shares and hopes to maintain a business relationship with them. Toray is honored to make a contribution to the treatment of life-threatening cardio-vascular disease in North America by licensing Beraprost to United Therapeutics."
Beraprost is the only orally-available drug approved anywhere in the world in the class of medicines called prostacyclin. This class is based upon the prostacyclin molecule that is normally made and broken-down continuously within the human body. Of all the molecules made within the body, prostacyclin has the greatest responsibility for maintaining the health of blood vessels. When certain diseases strike, the body does not produce enough prostacyclin, and death or disability usually results. One such disease is called pulmonary vascular disease, a heart-lung disorder that arises from collapsed blood vessels within the lungs and consequent high blood pressure just between the heart and lungs. Prostacyclin replacement therapy is the main successful treatment for this condition, although it is currently available only as a 24 hour-a-day, life-long intravenous drip.
The Second U.S. National Health and Nutrition Examination Survey provided chest x-ray measurements from which a disease prevalence estimate was made by Dr. Stuart Rich, MD, Chairman of the World Health Organization Conference on Pulmonary Hypertension. Dr. Rich estimated that pulmonary vascular disease may afflict 13% of men over the age of 34. Typical symptoms of pulmonary vascular disease include breathlessness with only modest exertion, and, in late stages, unexplained fainting and ultimately both if untreated. Recently, news reports cited "Redux" and "Phen-Fen," pills taken mostly by young women to lose weight, to be linked to an increased incidence of pulmonary vascular disease. Approximately 2000 Americans, including some of these women, exist on continuous, lifelong intravenous prostacyclin today.
United Therapeutics' clinical development team, based in Research Triangle Park, North Carolina, will lead the patient trials of Beraprost in North America. Dr. James Crow, who developed and won FDA approval for the intravenous form of prostacyclin in 1995, leads this team. The Scientific Advisory Board of United Therapeutics is chaired by Nobel Laureate Sir John Vane, and vice-chaired by Prof. Salvador Moncada, the two co-discoverers of prostacyclin in the 1970s.