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Horizon Therapeutics Presents Phase 3 Study Results Identifying Risk Factors for Ulcer Development Among NSAID Users
Date:10/26/2009

SAN DIEGO, Oct. 26 /PRNewswire/ -- Horizon Therapeutics, Inc., a privately held biopharmaceutical company, today presented an analysis from two pivotal Phase 3 trials (REDUCE-1 and REDUCE-2) evaluating its lead investigational compound HZT-501, a combination of ibuprofen with high-dose famotidine. The analysis, which was designed to identify risk factors for the development of non-steroidal anti-inflammatory drug (NSAID)-associated ulcers, was presented at the 74th American College of Gastroenterology (ACG) Annual Scientific Meeting.

"Upper gastrointestinal tract ulcers develop commonly in people taking NSAIDs and can occur without warning symptoms. Historically there have been limited data identifying the factors that predict an increased risk of finding ulcers in NSAID users," said Loren Laine, MD, University of Southern California Keck School of Medicine and lead investigator. "Data collected from the REDUCE-1 and REDUCE-2 trials provide insight into these risk factors. The statistically significant independent risk factors included the use of the NSAID ibuprofen without the histamine-2 receptor antagonist famotidine, previous ulcer disease and older age."

The two pivotal Phase 3 clinical trials, REDUCE-1 and REDUCE-2 (Registration Endoscopic Studies to Determine Ulcer Formation of HZT-501 Compared to Ibuprofen: Efficacy and Safety Studies), conducted via a Special Protocol Assessment (SPA) with the U.S. Food and Drug Administration (FDA), were randomized, double-blind, controlled trials that enrolled more than 1500 patients with mild-to-moderate pain. Patients were randomly assigned, in approximately a 2:1 ratio, to receive either HZT-501 (800 mg ibuprofen and 26.6 mg famotidine) or the NSAID ibuprofen (800 mg) alone orally three times daily for a 24-week treatment period or until patients developed either an endoscopically diagnosed upper gastrointestinal (GI) ulcer and/or prohibitive toxicity. Results showed that patients with mild-to-moderate pain treated with HZT-501 developed approximately 50 percent fewer NSAID-associated upper GI ulcers compared to patients treated with ibuprofen alone.

The statistical analysis looked at the combined 1,382 patients studied in the REDUCE-1 and REDUCE-2 primary study populations (HZT-501, N=930; ibuprofen, N=452). The predefined population for primary analyses of upper GI ulcers was all patients with at least one on-study endoscopy (EGD). The life table analysis estimate showed that fewer patients taking HZT-501 developed upper GI ulcers than those taking ibuprofen alone after 24 weeks (14.1% vs. 26.5%, p<0.0001). A multivariable proportional hazard regression analysis was done to assess potential risk factors for upper GI ulcer development in the combined studies. The following chart highlights the most prevalent risk factors derived from the analysis:



                   Analysis Factor                Relative Risk (95% CI)
                   ---------------                ---------------------
           Ibuprofen (without famotidine)           2.18 (1.64, 2.90)

                     Prior ulcer                    1.65 (1.01, 2.69)

                      Age >=65                      1.54 (1.10, 2.17)

                  Low-dose aspirin                  1.46 (1.00, 2.11)

                       Female                       1.15 (0.84, 1.57)

       Baseline erosions (GI erosions noted on
        baseline endoscopy at the start of the
        study)                                      1.15 (0.82, 1.62)


"By identifying these independent risk factors, physicians may be able to better assess a patient's risk for NSAID-associated GI toxicity," said Timothy P. Walbert, president and chief executive officer of Horizon Therapeutics. "For patients with chronic pain who are at increased GI risk, HZT-501 may be an important treatment option."

About HZT-501

HZT-501 is a novel, proprietary fixed-dose tablet combining the most prescribed NSAID in the U.S., ibuprofen, with a high dose of the most potent H2 antagonist, famotidine, 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-associated upper GI ulcers.

About the Arthritis and Pain Market

According to the Arthritis Foundation, arthritis affects 46 million people in the U.S. 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 GI complications, including ulcers. NSAIDs block enzymes and reduce prostaglandins throughout the body and as a consequence, ongoing inflammation, pain, and fever are reduced. Because 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 U.S. alone.

If deaths from the gastrointestinal effects of NSAIDs were tabulated separately in the National Vital Statistics reports, these effects would equate to the 15th most common cause of death in the U.S. Studies have shown that less than 30 percent of high-risk NSAID patients are co-prescribed a gastro-protective agent in combination with their NSAID. In addition, patient adherence to a regimen of separate pain and GI protective medications has been shown to be poor.

About Horizon Therapeutics

Horizon Therapeutics, Inc. is a late-stage biopharmaceutical company focused on the development and commercialization of therapies for the treatment of mild-to-moderate pain and arthritis. Horizon's clinical portfolio includes innovative combination therapies in early- and late-stage development that are designed to improve safety, efficacy and patient compliance. For more information about the company and its products, please visit www.horizontherapeutics.com.

SOURCE Horizon Therapeutics, Inc.


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SOURCE Horizon Therapeutics, Inc.
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