Horizon Therapeutics Presents Phase 3 Study Results Identifying Risk Factors for Ulcer Development Among NSAID Users

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.

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.

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.

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.

CONTACT: Robert De Vaere, Executive Vice President, Chief Financial
Officer, Horizon Therapeutics, Inc., +1-760-436-4010,
bdevaere@horizontherapeutics.com; or Molly Rabinovitz of WeissComm
Partners, +1-312-646-6294, mrabinovitz@wcpglobal.com, for Horizon
Therapeutics, Inc.

Web site: http://www.horizontherapeutics.com/