DEERFIELD, IL--(Marketwired - September 05, 2013) - Horizon Pharma, Inc. (NASDAQ: HZNP) today announced that the United States Food and Drug Administration has approved the use of Sanofi's manufacturing site in Compiegne, France to manufacture DUEXIS® (ibuprofen/famotidine), a proprietary single-tablet combination of ibuprofen (800 mg) and famotidine (26.6 mg). Valeant Pharmaceuticals' manufacturing site in Laval, Quebec, previously owned and operated by Sanofi, serves as the primary commercial manufacturing site for DUEXIS.
"We have had a successful long-term partnership with Sanofi and are pleased with the FDA's approval of the Compiegne site as an additional manufacturing facility for DUEXIS," said Hans-Peter Zobel, Ph.D., senior vice president, manufacturing, Horizon Pharma. "This approval provides us a quality backup manufacturing site, enhancing our ability to ensure an adequate long-term supply of DUEXIS."
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 www.DUEXIS.com.
About Horizon Pharma
Horizon Pharma, Inc. is a specialty pharmaceutical company that has developed and is commercializing DUEXIS and RAYOS/LODOTRA, both of which target unmet therapeutic needs in arthritis, pain and inflammatory diseases. The Company's strategy is to develop, acquire and in-license additional innovative medicines where it can execute a targeted commercial approach in specific therapeutic areas while taking advantage of its commercial strengths and the infrastructure the Company has put in place. For more information, please visit www.horizonpharma.com.
This press release contains forward-looking statements, including statements regarding Horizon's ability to ensure an adequate long-term supply of DUEXIS. 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 Sanofi's ability to comply with on-going regulatory requirements with respect to the Compiegne facility, whether Horizon's manufacturing agreement with Sanofi will be terminated early and whether each party will be able to satisfy its performance obligations under the manufacturing agreement. For a further description of these and other risks facing Horizon, please see the risk factors described in Horizon'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 Horizon undertakes no obligation to update or revise these statements, except as may be required by law.