Download United Therapeutics Completes Enrollment In Phase III Study of First

For Immediate Release
For Further Information Contact:
Therese Fergo, 301-608-9292
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United Therapeutics Completes Enrollment In
Phase III Study of First Oral Therapy for Early-Stage Pulmonary Hypertension
Research Triangle Park, NC, February 26, 2001: United Therapeutics Corporation
(NASDAQ: UTHR) announced today that it has completed enrollment in its Phase III
study of oral beraprost in patients with pulmonary hypertension. Approximately 116
patients in ten centers in the United States were randomized into the double-blind,
placebo-controlled study in patients with moderate pulmonary hypertension.
Pulmonary hypertension is characterized by sustained elevations in pulmonary artery
pressure, resulting in increased strain on the right side of the heart and ultimately right
heart failure. Common early symptoms include shortness of breath, fatigue, angina and
syncope (fainting spells), particularly with exertion.
Patients with advanced pulmonary hypertension are treated with a chronic, intravenous
infusion of prostacyclin (Flolan®), the only currently approved therapy. The invasive
nature of this treatment has made it less attractive to patients with moderate or early stage
disease. As an orally active prostacyclin analog, beraprost is formulated as a tablet and
therefore may provide a more acceptable treatment option for patients with the early
stage of the disease. On October 16, 2000, United Therapeutics announced that it had
filed an application with the FDA for marketing approval of a subcutaneous prostacyclin
analog, Remodulin, for patients with moderate to severe pulmonary hypertension.
Beraprost is approved in Japan for the treatment of patients with primary pulmonary
hypertension and therefore represents the first oral therapy indicated for the treatment of
this disease. “We are excited about the development of beraprost in North America as it
represents a significantly more convenient treatment alternative. The results of this study
will form the basis of our regulatory strategy for this indication,” said Roger Jeffs, Ph.D.
Vice President of Research, Development and Medical for United Therapeutics.
Efficacy results from the study are expected to be available in 2002, as patients are being
evaluated over a 12-month period. The study is assessing the effects of beraprost on
exercise performance, cardiopulmonary hemodynamics, signs and symptoms of disease
and quality of life.
Beraprost was exclusively licensed to United Therapeutics by Toray Industries, Inc. of
Japan for the North American market. On February 20, 2001, United Therapeutics
announced that it had completed enrollment in its Phase III study of beraprost in patients
with intermittent claudication.
United Therapeutics is a biotechnology company focused on combating cardiovascular,
inflammatory and infectious diseases with unique therapeutic products.