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For Immediate Release
For Further Information Contact:
Teresa Bongartz, 301-608-9292
Email [email protected]
UNITED THERAPEUTICS OBTAINS EXCLUSIVE NORTH AMERICAN
RIGHTS TO SUSTAINED RELEASE FORMULATIONS OF THE
ORAL PROSTACYCLIN BERAPROST
Silver Spring, MD, and Research Triangle Park, NC, June 29, 2000: United
Therapeutics Corporation (NASDAQ: UTHR) announced today that it had signed an
agreement with Toray Industries of Japan for the exclusive North American
rights to develop and commercialize sustained release formulations of the oral
prostacyclin Beraprost for all vascular and cardiovascular diseases. Beraprost
is an orally available tablet form of prostacyclin that is already approved in
Japan and Korea for the treatment of chronic arterial occlusion and pulmonary
hypertension.
"We are very pleased to continue our prostacyclin development activities with
sustained release formulations," said Martine Rothblatt, Chairman and CEO of
United Therapeutics. "Toray Industries has been a wonderful corporate partner
and we are proud to have been selected by them as their American partner for
sustained release molecules."
"We are impressed with the drug development track record of United Therapeutics
for our immediate release formulation," said Kiyoteru Wakasugi, Managing
Director of the Board of Toray Industries. "We are very pleased to extend our
relationship with United Therapeutics for the further development of these
molecules with the signing of this agreement."
United Therapeutics is currently conducting the second of two Phase III studies
of an immediate release oral formulation of Beraprost for early stage
peripheral vascular disease as well as a Phase III study of the same drug in
early-stage pulmonary hypertension. Peripheral vascular disease causes
intermittent leg pain when walking and, in some patients, severe leg pain even
when at rest. Pulmonary hypertension causes breathlessness, fainting and, in
some patients, right heart failure.
United Therapeutics announced that the terms of the exclusive licensing
agreement provided for it to pay Toray $1 million plus 200,000 shares of United
Therapeutics' common stock upon signing and to grant Toray an option to
purchase 500,000 additional shares upon the transfer by Toray to United
Therapeutics of sustained release clinical trial material expected in 2001.
Additional payments totaling $750,000 are due to Toray from United Therapeutics
upon the occurrence of drug development milestones. United Therapeutics will
also owe Toray a daily dosage fee and a variable percent of revenues fee upon
sales of the drug after regulatory approval is obtained. The agreement provides
for United Therapeutics to develop the sustained release formulation in time
for a 2004 regulatory approval, subject to various provisions for extensions of
this date.
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United Therapeutics is a pharmaceutical company with Phase III programs in
pulmonary hypertension, peripheral vascular disease and osteoarthritis, as well
as pre-clinical projects in cardiovascular, respiratory and infectious
diseases.
Toray Industries, Inc. is the world's leading manufacturer of synthetic fibers,
textiles and plastics, and pioneering new technologies such as carbon fibers
and "Ultra Suede". Toray is focusing one of its activities in the
pharmaceuticals industry, successfully launching Interferon-beta and Beraprost
in Japan and intensively conducting clinical trials for new pharmaceutical
compounds.
