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For Further Information Contact:
Therese Fergo (301/608-9292)
[email protected]
UNITED THERAPEUTICS PLANS EXPECTED TRANSITION
TO COMMERCIAL OPERATIONS
Silver Spring, MD and Research Triangle Park, NC, December 1, 2000: United
Therapeutics Corporation (NASDAQ: UTHR) announced today that it has been advised
by the FDA that February 9, 2001 is the date for the Cardiovascular and Renal
Drugs Advisory Committee review of United Therapeutics' New Drug Application
(NDA) for UT-15. UT-15 (with a pending tradename of Uniprost) is being developed
by United Therapeutics as a subcutaneous treatment for pulmonary arterial
hypertension. UT-15 is an analog of prostacyclin, which is a molecule produced
naturally within the body to keep blood vessels healthy. People with pulmonary
arterial hypertension have sharply reduced levels of prostacyclin within the
blood vessels in their lungs, resulting in dizziness, fainting, diminished
exercise ability and potentially right heart failure.
United Therapeutics submitted its UT-15 NDA on October 16, 2000 and was granted
six-month priority review status on October 19, 2000.
"We are pleased to have this FDA Advisory Committee date set," said Martine
Rothblatt, Chairman and CEO of United Therapeutics. "We have decided to initiate
our European regulatory approval with an initial filing in France during the
first quarter of 2001. We expect to achieve regulatory approval in other
countries subsequent to receiving French approval," Ms. Rothblatt added.
"Consequently," continued Ms. Rothblatt, "if we are successful in receiving FDA
approval by mid-2001, we are targeting revenues for 2001 in the neighborhood of
$10 million to $20 million, based on only a partial year of revenue in the
United States and the fact that approximately half of our current 500 patients
are located within the United States. Our internal goal is to have 1,000
patients on UT-15 by the end of 2001, of which at least 500 would be based in
the United States, and twice as many patients by the end of 2002, when the major
approvals outside of the United States
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should be in place. Our 2002 revenue target based on these expectations is
between $75 million to $100 million."
United Therapeutics also announced that it now expects to complete enrollment of
patients in its six-month study of beraprost for peripheral vascular disease in
the first quarter of 2001. Full-year revenues from beraprost are expected to
commence in 2003, subject to the achievement of satisfactory pivotal trial
results and regulatory approval.
The Company also announced certain management changes effective with the planned
mid-2001 launch of UT-15 for pulmonary hypertension. Dr. James W. Crow,
President and Chief Operating Officer, and a co-founder of the company, will
retire upon the successful completion of his efforts to obtain FDA approval for
UT-15. He will be succeeded by Dr. Roger Jeffs, currently Vice President for
Clinical, Scientific & Medical Affairs. Dr. Crow has agreed to continue with the
company after FDA approval as President Emeritus. Dr. Gilles Cloutier, also a
co-founder of United Therapeutics, will retire as Executive Vice President for
Business Development and is expected to serve as a consultant to the company.
Shelmer Blackburn, Jr., formerly Vice President for Operations, has been
promoted to Executive Vice President for Medical Affairs. Dr. David Walsh,
formerly Vice President and Chief Operating Officer of the company's SynQuest
manufacturing subsidiary, has been promoted to Executive Vice President and
Chief Operating Officer, Production, of United Therapeutics. Dr. David Mottola,
formerly Director of Clinical and Scientific Affairs, has been promoted to Vice
President for Clinical and Scientific Affairs. Dean Bunce, formerly Associate
Director Regulatory Affairs, has been promoted to Director Regulatory Affairs.
Drs. Robert Roscigno and Michael Wade were promoted to Associate Director,
Clinical and Commercial Operations and Associate Director, Research and
Development, respectively. Jo Baker, formerly Senior Clinical Research
Associate, has been promoted to Manager, Clinical Affairs.
United Therapeutics is a biotechnology company focused on combating
cardiovascular, inflammatory and infectious diseases with unique therapeutic
products.
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This press release contains forward-looking statements including statements
concerning initiation and achievement of European regulatory approvals,
receiving FDA approval of UT-15 in 2001, target UT-15 revenues for 2001,
internal goals for UT-15 in 2001 and 2002, target UT-15 revenues for 2002,
completion of enrollment of beraprost trial patients in the first quarter 2001,
receiving FDA approval of beraprost in 2002 and certain management changes
expected in mid-2001. These statements are subject to risks and uncertainties,
which may cause actual results to differ materially, including those related to
regulatory approval processes, the ability of the company to complete and file
approval requests in Europe, patient outcomes, clinical variables and the
ability of the company to successfully market UT-15 in the United States and
Europe.
