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For Immediate Release
For Further Information Contact:
Therese Fergo, 301-608-9292
Email [email protected]
UNITED THERAPEUTICS DISCONTINUES KETOTOP
OSTEOARTHRITIS PROGRAM BASED ON PHASE 3 TRIAL RESULTS
Silver Spring, MD, December 7, 2000: United Therapeutics (NASDAQ: UTHR)
announced today that it has received the results from its Phase 3 study
investigating the transdermal patch Ketotop for the treatment of osteoarthritis
of the knee.
While individual endpoints in the 500 patient study achieved statistical
significance, the key clinical and regulatory endpoint related to pain
reduction did not meet the company's expectations. Based on these results,
United Therapeutics has decided to discontinue development of Ketotop which the
Company had expected to launch in 2003 had the data been favorable.
"While we're disappointed with the results of this study, Ketotop has never
been a primary target product for us," said Martine Rothblatt, Chairman and CEO
of United Therapeutics. "We remain committed to achieving approval and
commercializing our lead drugs, UT-15 and Beraprost, as well as to further
developing our next generation prostacyclin molecules and our broad iminosugar
platform. Our pipeline remains robust, with our pulmonary hypertension product
pending FDA approval, our intermittent claudication product halfway through its
second Phase 3 trial, our critical limb ischemia product in Phase 2 and our
hepatitis B product nearing Phase 1. In addition, we are reviewing a number of
acquisition opportunities."
United Therapeutics is a biotechnology company focused on combating
cardiovascular, inflammatory and infectious diseases with unique therapeutic
products.
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