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Horizon Therapeutics Initiates Long-Term Phase 3 Safety Study for Lead Product Candidate HZT-501

- Ongoing Phase 3 clinical development program will examine HZT-501 as a

potential new 'GI-friendly' NSAID for mild to moderate pain -

PALO ALTO, Calif., Oct. 8 /PRNewswire/ -- Horizon Therapeutics, Inc., a privately held biopharmaceutical company, today announced that it has initiated a phase 3 follow-on safety study (protocol HZ-CA-304) of its lead product candidate HZT-501, an investigational prescription NSAID (non-steroidal anti-inflammatory drug) designed to be "GI-friendly".

HZT-501 is a proprietary formulation of ibuprofen, the most prescribed NSAID in the United States, combined with famotidine, the most potent H2 receptor antagonist, in a single pill. HZT-501 is specifically designed to provide pain relief while reducing stomach acidity during the peak time of risk for gastric ulceration. In a randomized pilot clinical study published in The New England Journal of Medicine (Taha, et. al May 1996), famotidine was demonstrated to significantly reduce the incidence of gastric and duodenal ulcers vs. placebo when administered together with NSAIDs.

"This study is designed to examine the long-term safety of HZT-501 as part of the overall clinical trial program," said George F. Tidmarsh, M.D., Ph.D., co-founder and chief executive officer of Horizon Therapeutics. "We hope that the trial results offer patients, physicians and regulatory authorities a robust set of data to evaluate HZT-501."

The safety study will support the two ongoing pivotal phase 3 trials involving a total of 1,400 patients with mild-to-moderate pain, including patients with osteoarthritis. Horizon protocols HZ-CA-301 and HZ-CA-303 will evaluate the efficacy and safety of HZT-501 with the primary endpoint being reduction in the risk of development of ibuprofen-associated upper gastrointestinal ulcers in patients who require the use of ibuprofen. The trials began in March 2007, and an NDA is targeted to be filed Q4 2008.

The HZ-CA-304 phase 3 follow-on 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 combination products in earlier stages of development. For more information visit

SOURCE Horizon Therapeutics, Inc.
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