SOURCE: Horizon Pharma

Horizon Pharma

February 11, 2014 16:40 ET

Horizon Pharma Provides Update on February 10-11, 2014 FDA Joint Advisory Committee Meeting on Cardiovascular Risk of NSAIDs

Committee Did Not Find the Data Support a Difference in CV Risk Among NSAIDs

DEERFIELD, IL--(Marketwired - Feb 11, 2014) - Horizon Pharma, Inc., (NASDAQ: HZNP), a commercial stage, specialty pharmaceutical company that markets two gastroprotective nonsteroidal anti-inflammatory drugs (NSAIDs), VIMOVO® (naproxen/esomeprazole magnesium) and DUEXIS® (ibuprofen and famotidine), announced that the FDA joint Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee was split on whether the data show adequate differences in cardiovascular risk among NSAIDs to support labeling change for NSAIDs due to cardiovascular (CV) risk. The committee found that there was not enough data at this time to differentiate among the NSAIDs. During the discussion, the committee did recognize the risk of gastrointestinal (GI) events when taking NSAIDs. The FDA will take the committee's discussion into consideration and will make the final determination in this matter.

"Osteoarthritis and rheumatoid arthritis are often highly debilitating and the source of significant distress for millions of people, yet the potential cardiovascular risks associated with NSAIDs can be a treatment barrier for many patients," said Alfonso E. Bello, M.D., director of clinical research, Illinois Bone and Joint Institute and clinical associate professor of medicine, University of Illinois College of Medicine. "The committee discussion reinforces the potential CV risk of NSAIDs and the need for physicians to discuss this with their patients. While the committee vote was split, the committee did acknowledge the potential to differentiate naproxen from the other NSAIDs. While we still need to determine how best to manage the CV risk, we can manage the more common risk of GI events through gastroprotection."

"Recognizing that individuals respond differently to NSAIDs, we make available two prescription strength NSAID options, VIMOVO® and DUEXIS®, both of which have demonstrated a significant reduction in gastrointestinal ulcers, allowing prescribers the ability to treat a broad range of arthritis patients," said Timothy P. Walbert, chairman, president and chief executive officer, Horizon Pharma. "We are committed to bringing safe and effective treatment options to patients."

VIMOVO® (naproxen / esomeprazole magnesium) is a proprietary fixed-dose combination of delayed-release enteric-coated naproxen, a non-steroidal anti-inflammatory drug (NSAID) and immediate-release esomeprazole, a stomach acid-reducing proton pump inhibitor (PPI), approved for the relief of signs and symptoms of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis and to decrease the risk of developing gastric ulcers in patients at risk of developing NSAID-associated gastric ulcers. VIMOVO is not recommended for use in children younger than 18 years of age. VIMOVO is not recommended for initial treatment of acute pain because the absorption of naproxen is delayed compared to absorption from other naproxen-containing products. Controlled studies do not extend beyond 6 months. VIMOVO should be used at the lowest dose and for the shortest amount of time as directed by a health care provider. For Full Prescribing Information, see

DUEXIS, a proprietary single-tablet combination of the NSAID ibuprofen and the histamine H2-receptor antagonist famotidine, is indicated for the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis and to decrease the risk of developing upper gastrointestinal ulcers, which in the clinical trials was defined as a gastric and/or duodenal ulcer, in patients who are taking ibuprofen for those indications. The clinical trials primarily enrolled patients less than 65 years of age without a prior history of gastrointestinal ulcer. Controlled trials do not extend beyond 6 months. For more information, please visit

About the Arthritis Market
Some of the most common and debilitating chronic inflammation and pain-related diseases are osteoarthritis, or OA and rheumatoid arthritis or RA.

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 effective at providing OA and RA symptom 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 commercial stage, specialty pharmaceutical company that markets DUEXIS®, RAYOS®/LODOTRA® and VIMOVO®, which target unmet therapeutic needs in arthritis, pain and inflammatory diseases. The Company's strategy is to develop, acquire or in-license additional innovative medicines or companies where it can execute a targeted commercial approach among specific target physicians such as primary care physicians, orthopedic surgeons and rheumatologists, while taking advantage of its commercial strengths and the infrastructure the Company has put in place. For more information, please visit

Forward Looking Statements
This press release contains forward-looking statements, including statements regarding the conclusions of the FDA joint committee regarding CV risk of NSAIDs and the potential to differentiate naproxen from other NSAIDs with regard to CV risk. These forward-looking statements are based on management's expectations and assumptions as of the date of this press release and actual results may differ materially from those in these forward-looking statements as a result of various factors, including whether the FDA adopts the committee's recommendation and other risks facing the Company, as described in the Company's filings with the United States Securities and Exchange Commission, 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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