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Horizon Pharma, Inc. (HZNP) Announces Availability Of Horizon-Labeled VIMOVO(R) In The United States


1/3/2014 9:28:05 AM

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DEERFIELD, IL--(Marketwired - January 02, 2014) - Horizon Pharma, Inc. (NASDAQ: HZNP) today announced that Horizon-labeled VIMOVO® (naproxen/esomeprazole magnesium) delayed-release tablets are now available to U.S. physicians. VIMOVO is approved for the relief of signs and symptoms of osteoarthritis (OA), rheumatoid arthritis (RA) and ankylosing spondylitis and to decrease the risk of stomach (gastric) ulcers in patients at risk of developing stomach ulcers from treatment with NSAIDs. VIMOVO is a proprietary fixed-dose combination of enteric-coated naproxen, a pain-relieving non-steroidal anti-inflammatory drug (NSAID) and immediate-release esomeprazole, a proton pump inhibitor (PPI). The Company expects to begin the commercial launch of Horizon-labeled VIMOVO with its primary care sales force on February 3, 2014.

"The availability of Horizon-labeled VIMOVO is a major milestone for us as we plan for our full commercial launch. We expect to complete hiring and training our expanded sales force this month and commence our launch of VIMOVO in early February," stated Timothy P. Walbert, chairman, president and chief executive officer, Horizon Pharma. "Effective today, VIMOVO is now available via our co-pay program and is also included in our Prescriptions-Made-Easy™ specialty pharmacy program, ensuring VIMOVO is available at a reasonable out-of-pocket cost to patients."

According to the Arthritis Foundation, more than 50 million adults (one in every five) in the U.S. have doctor diagnosed arthritis. Arthritis prevalence increases with age with 50 percent of adults age 65 and older having some form of arthritis. By the year 2030, an estimated 67 million American adults will have arthritis.

NSAIDs are effective at providing pain and inflammation relief associated with OA and RA; however, there are significant upper GI-associated adverse events which can result from such treatments and patients with OA and RA taking NSAIDs are at increased risk for upper GI ulcers.

VIMOVO was approved by the FDA in April 2010, supported by data from two pivotal studies in which patients received either VIMOVO or enteric-coated naproxen 500 mg, twice daily, over a six-month treatment period. Data from one study (PN400-301) showed a 4.1% incidence of gastric ulcers in patients taking VIMOVO, compared to 23.1% among patients taking enteric-coated naproxen (p < 0.001). A second study (PN400-302) showed a 7.1% incidence of gastric ulcers among patients taking VIMOVO, compared to 24.3% with enteric-coated naproxen (p < 0.001). Endoscopies were performed at baseline and at one, three and six months. The safety of VIMOVO was evaluated in clinical studies involving 2,317 patients (aged 27 to 90 years) and ranging from 3-12 months. The most commonly observed adverse events in the clinical trials (experienced by > 5% of patients in the VIMOVO group) were erosive gastritis, dyspepsia, gastritis, diarrhea, gastric ulcer, upper abdominal pain and nausea.

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 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 www.horizonpharma.com.

About VIMOVO

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 www.VIMOVO.com.

Forward Looking Statements

This press release contains forward-looking statements, including statements regarding Horizon's plans and expectations with respect to its commercialization of VIMOVO in the United States, including the planned increase in its field sales force and the timing of its commercial launch of VIMOVO in the United States, and expected increases in the prevalence of arthritis in the United States. 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. These factors include, but are not limited to, risks regarding Horizon's ability to commercialize its products successfully, Horizon's ability to successfully hire and manage sales and marketing personnel, Horizon's ability to comply with post-approval regulatory requirements, and the outcome of on-going and potential future patent litigation with respect to Horizon's products, including VIMOVO. For a further description of these and other risks facing the Company, please see the risk factors 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.


Contacts
Investors
Robert J. De Vaere
Executive Vice President, Chief Financial Officer
Email Contact



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