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Horizon Therapeutics Announces Two Pivotal HZT-501 Phase 3 Trials Meet Primary Endpoints
Date:12/2/2008

for patients treated with NSAIDs."

About HZT-501

HZT-501 is a novel, proprietary fixed-dose combination formulation of the world's most prescribed NSAID, ibuprofen, with a high dose of the most potent H2 antagonist, famotidine (Pepcid(R)), in a single pill. It is anticipated that HZT-501 will provide effective pain relief and reduce stomach acidity during the peak time of ulceration risk, thus reducing the risk of NSAID-induced ulcers. HZT-501 has completed Phase 3 trials and the Company expects to submit a new drug application (NDA) to the U.S. federal drug administration (FDA) and a marketing authorization application (MAA) to the European Medicines Agency (EMEA) in the second half of 2009.

About the Arthritis and Pain Market

According to the Arthritis Foundation, arthritis affects 46 million people in United States and costs the U.S. economy $128 billion annually. According to a study by the Centers for Disease Control and Prevention (CDC) for the National Arthritis Data Workgroup, due to the increasing aging population, arthritis is projected to increase by 40 percent in the next two decades. The CDC estimates that 67 million people will be affected by arthritis by 2030. Additionally, chronic pain affects an estimated 86 million American adults. NSAIDs are among the most widely used drugs in the world for the treatment of arthritis and pain and are a major cause of gastrointestinal complications, including ulcers. NSAIDs block enzymes and reduce prostaglandins throughout the body and as a consequence, ongoing inflammation, pain, and fever are reduced. Since the prostaglandins that protect the stomach are reduced, NSAIDs often cause ulcers in the stomach. NSAID-induced GI toxicity causes an estimated 16,500 deaths and more than 107,000 hospitalizations annually in the United States alone.

If deaths from the gastrointestinal effects of NSAIDs were tabulated separately in
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SOURCE Horizon Therapeutics, Inc.
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