Horizon Pharma and Sanofi Announce FDA Approval of DUEXIS® Commercial Manufacturing Facility

Nov 14 2011

DEERFIELD, IL. and BRIDGEWATER, N.J.  — Horizon Pharma, Inc. (NASDAQ:  HZNP) and Sanofi announced today that the U.S. Food and Drug Administration (FDA) has approved the use of the sanofi-aventis Canada Inc. manufacturing site in Laval, Quebec to manufacture DUEXIS®,
(ibuprofen/famotidine) a proprietary single-tablet combination of ibuprofen (800 mg) and famotidine (26.6 mg).  DUEXIS was approved by the FDA in April 2011. Sanofi will serve as the primary commercial manufacturer for DUEXIS in the United States.

“The approval of the Sanofi Laval manufacturing site provides Horizon with an experienced commercial manufacturer as we move forward with the launch of DUEXIS,” said Timothy P. Walbert, chairman, president and chief executive officer of Horizon Pharma. “We look forward to making DUEXIS available in the next few weeks to patients who suffer from osteoarthritis and rheumatoid arthritis and who may be at risk for upper gastrointestinal ulcers stemming from ibuprofen use.”

About 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.

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.

About Sanofi

Sanofi, a global and diversified healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients’ needs. Sanofi has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, rare diseases, consumer healthcare, emerging markets and animal health. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).  Sanofi is represented in Canada by the pharmaceutical company sanofi-aventis Canada Inc., based in Laval, Quebec, and by the vaccines company Sanofi Pasteur Limited, based in Toronto, Ontario. Together they employ more than 2,000 people across the country. With combined R&D investments of $159.2 million in 2010, they are leaders in Canada’s biopharmaceutical sector, a critical knowledge-based industry that generates jobs,business and opportunity throughout the country.