NORTHBROOK, IL--(Marketwire - November 02, 2010) - Horizon Pharma, Inc. today announced that four abstracts on its two lead product candidates, HZT-501, a fixed-dose combination of ibuprofen and high-dose famotidine, and LODOTRA®, a programmed release formulation of low-dose prednisone, will be presented during the American College of Rheumatology Annual Scientific Meeting, November 7-11 in Atlanta.
HZT-501 Studies to be Presented
- Long Term Safety of an NSAID with Built-in Gastroprotection for Treatment of Pain and Inflammation Related to OA and RA: Results from a One Year Safety Trial of a Single-Tablet Combination of Ibuprofen-Famotidine vs. Ibuprofen Alone
- Author: Michael Schiff, M.D., medical director of the Denver Arthritis Clinic Research Unit and professor of clinical medicine at the University of Colorado School of Medicine
- Presentation number: 946
- Date/time of presentation: Poster session B, Tuesday, November 9, 2010, 9 - 11 a.m. EST
- Location: Hall B1 and B2
- Efficacy, Safety and Tolerability of HZT-501, Including Users of Low-Dose Aspirin, a Single-Tablet Combination of Ibuprofen-Famotidine: Results of Two Phase 3 Trials
- Author: Michael E. Weinblatt, M.D., co-director of Clinical Rheumatology at the Brigham and Women’s Hospital and professor of Medicine at Harvard Medical School
- Presentation number: 945
- Date/time of presentation: Poster session B, Tuesday, November 9, 2010, 9 - 11 a.m. EST
- Location: Hall B1 and B2
LODOTRA Studies to be Presented
- Low-Dose Glucocorticoid Chronotherapy of Rheumatoid Arthritis: 12 Week Efficacy and Safety of Modified-Release (MR) Prednisone
- Author: Frank Buttgereit, M.D., senior consultant and deputy head of the Department of Rheumatology and Clinical Immunology, Charité Hospital, Berlin
- Presentation number: 392
- Date/time of presentation: Poster session A, Monday, November 8, 2010, 9 - 11 a.m. EST
- Location: Hall B1 and B2
- Safety of a Novel Modified-Release (MR) Prednisone Formulation: Results of the Circadian Administration of Prednisone in Rheumatoid Arthritis (CAPRA) Studies
- Author: Frank Buttgereit, M.D., senior consultant and deputy head of the Department of Rheumatology and Clinical Immunology, Charité Hospital, Berlin
- Presentation number: 1123
- Date/time of presentation: Poster session B, Tuesday, November 9, 2010, 9 - 11 a.m. EST
- Location: Hall B1 and B2
About HZT-501
HZT-501 is a novel single tablet formulation containing a fixed-dose combination of ibuprofen, one of the most widely prescribed NSAIDs, and high-dose famotidine, a well-established GI agent used to treat dyspepsia, gastroesophageal reflux disease (GERD) and active ulcers, and to reduce the risk of NSAID-induced upper GI ulcers. Ibuprofen has proven anti-inflammatory and analgesic properties, and famotidine reduces the stomach acid secretion that can cause upper GI ulcers. Both ibuprofen and famotidine have well-documented and excellent long-term safety profiles, and both products have been used for many years by millions of patients worldwide.
HZT-501 is currently under review by the U.S. FDA with a PDUFA goal date of January 21, 2011. The Company also plans to submit a marketing authorization application (MAA) for DUEXA in the European Union through the Decentralized Procedure in the second half of 2010.
About LODOTRA
LODOTRA is a proprietary programmed-release formulation of low-dose prednisone and has received regulatory approval in Europe for reduction in morning stiffness associated with rheumatoid arthritis (RA). Merck KGaA holds marketing rights to LODOTRA in Germany and Austria and Mundipharma holds marketing rights to LODOTRA for the rest of Europe.
Horizon has completed a Phase 3 trial for LODOTRA in the United States for the treatment of the signs and symptoms of RA. The company anticipates submitting a New Drug Application (NDA) for LODOTRA for the treatment of the signs and symptoms of RA to the U.S. FDA in the second half of 2010.
About the Arthritis, Pain and Inflammation Market
Some of the most common and debilitating chronic inflammation and pain-related diseases are osteoarthritis, or OA, rheumatoid arthritis or RA, and acute and chronic pain.
Arthritis is a large and growing public health problem in the United States and continues to be the most common cause of disability. According the CDC, arthritis costs the U.S. economy nearly $128 billion annually in medical care and indirect expenses, including lost wages and productivity. From 2007-2009, approximately one in five (49.9 million) adults age 18 or older in the United States had self-reported doctor-diagnosed and 21.1 million adults (42.4% of those with arthritis) had self-reported arthritis-attributable activity limitation (AAAL). The CDC estimates that 67 million people in the U.S. will be affected by arthritis by 2030. Additionally, chronic pain affects an estimated 86 million American adults.
NSAIDs are very effective at providing pain relief, including pain associated with arthritis; however there are significant upper GI complications that can result from the use of NSAIDs, including ulcers. NSAID-induced GI toxicity causes an estimated 16,500 deaths and more than 107,000 hospitalizations annually in the U.S. alone. Recently published data also indicates that physicians only co-prescribe GI protective agents to NSAID users 24 percent of the time, and studies show sub-optimal patient compliance with the prescribed GI co-therapy
About Horizon Pharma
Horizon Pharma, Inc. is a biopharmaceutical company that is developing and commercializing innovative medicines to target unmet therapeutic needs in arthritis, pain and inflammatory diseases. For more information, please visit www.horizonpharma.com.
Forward Looking Statements
This press release contains forward-looking statements regarding the regulatory review of HZT-501, the potential for HZT-501 as a treatment to reduce the risk of developing NSAID-induced upper gastrointestinal ulcers in patients with mild to moderate pain and arthritis, and the arthritis and pain markets, as well as the U.S. regulatory review of LODOTRA and the potential of LODOTRA for the treatment of the signs and symptoms of RA. Actual results may differ materially from those in these forward-looking statements as a result of various factors, including, but not limited to, risks regarding regulatory review and approval of its product candidates, the company’s ability to commercialize products successfully, and competition in the markets for HZT-501 and LODOTRA. For a further description of these and other risks facing the company, please see the risk factors described in the company’s Registration Statement on Form S-1 that was originally filed with the United States Securities and Exchange Commission on August 3, 2010, and the amendments thereto, including those factors discussed under the caption “Risk Factors” in those filings. Forward-looking statements speak only as of the date of this press release, and the company undertakes no obligation to update or revise these statements, except as may be required by law.
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Robert J. De Vaere
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Molly Rabinovitz
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