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Horizon Therapeutics Initiates Long-Term Phase 3 Safety Study for Lead Product Candidate HZT-501
Date:10/8/2007

n safety study is a multi-center, double blind trial that will enroll approximately 200 patients who have participated in the 301 or 303 phase 3 trials. Study participants will continue to receive the same study medication they received in the other trials which was either HZT-501 (ibuprofen 800 mg/famotidine 26.6 mg) or ibuprofen 800 mg. Study participants will receive medication for up to 28 weeks.

About the Pain Market

HZT-501 targets the widespread medication void in the mild-to-moderate pain market left by COX-2 inhibitors which have either been taken off the market or are being prescribed less frequently due to elevated cardiovascular risk. From 2004 to 2006, the U.S. NSAID market grew over 20 percent to 73 million prescriptions. Over 26 million ibuprofen prescriptions are now written annually in the United States alone.

However, while commonly prescribed to treat pain, NSAIDs have been linked to serious gastrointestinal (GI) side effects in up to 25 percent of all chronic arthritis patients. NSAID-induced GI toxicity causes an estimated 16,000 deaths and more than 100,000 hospitalizations annually in the United States. Despite this, studies have shown that as low as 30% of high-risk patients are commonly co-prescribed a gastro-protective agent in combination with their NSAID. In addition, patient adherence to a regimen of separate GI protective and pain medications has also been shown to be poor.

About Horizon Therapeutics

Horizon Therapeutics, Inc. is a late stage biopharmaceutical company focused on the rapid development and commercialization of therapeutic treatments for mild-to-moderate pain management. The Company is building a novel portfolio of therapies through innovative combinations of approved pharmaceutical products that seek to improve safety, efficacy, and patient compliance. Its lead product candidate, HZT-501, entered Phase 3 trials in 2007. In addition to HZT-501, Horizon has a pipeline of follow-on pain combinat
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SOURCE Horizon Therapeutics, Inc.
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