Horizon Therapeutics Completes Enrollment in Phase 3 Trials for Lead Product Candida...( - Over 1500 U.S. patients enrolle...),Health

- Over 1,500 U.S. patients enrolled in study examining potential new

'GI-friendly' treatment for mild to moderate pain -

- Clinical results expected in second half of 2008 -

PALO ALTO, Calif., Feb. 11 /PRNewswire/ -- Horizon Therapeutics, Inc., a privately held biopharmaceutical company, today announced that it is closing enrollment in its two phase 3 trials HZ-CA-301 and HZ-CA-303 for its lead product candidate HZT-501, an investigational prescription NSAID (non-steroidal anti-inflammatory drug) designed to be "GI-friendly".

"We enrolled over fifteen hundred patients in less than a year, which was well ahead of our projections," said George F. Tidmarsh, M.D., Ph.D., co-founder and chief executive officer of Horizon Therapeutics. "We look forward to receiving the complete set of clinical results and safety data to review this Fall."

The Phase 3 program is comprised of two trials involving a total of 1,500 patients with mild-to-moderate pain, including patients with osteoarthritis. Horizon Protocol HZ-CA-301 and HZ-CA-303 are evaluating the efficacy and safety of HZT-501 with a primary endpoint of reduction in the risk of development of ibuprofen-associated upper gastrointestinal (gastric and/or duodenal) ulcers in patients who require the use of ibuprofen.

The clinical trials are multi-center, randomized, controlled, and blinded for up to 24 weeks of treatment, followed by a 4 week safety evaluation period. The studies are being conducted in the United States.

"The Horizon studies are among the largest endoscopic trials ever conducted regarding NSAID-induced gastrointestinal ulcers," said Loren Laine M.D., professor of medicine in the Division of Gastrointestinal and Liver Diseases, University of Southern California. "The results should provide precise estimates of the potential benefit of HZT-501 in decreasing NSAID-associated ulcers."

In addition, a phase 3 follow-on safety study HZ-CA-30
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