Horizon Pharma and Sanofi Announce FDA Approval of DUEXIS(R) Commercial Manufacturing Facility

Horizon Pharma and Sanofi Announce FDA Approval of DUEXIS(R) Commercial Manufacturing Facility


DEERFIELD, IL and BRIDGEWATER, NJ -- (MARKET WIRE) -- 11/14/11 -- 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."

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.

Important safety information

Risk of Serious Cardiovascular and Gastrointestinal Events

See full Prescribing Information for complete boxed warning

Ibuprofen, a component of DUEXIS, may increase the risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. Risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk.

DUEXIS is contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft surgery.

Nonsteroidal anti-inflammatory drugs (NSAIDs), including ibuprofen, a component of DUEXIS, increase the risk of serious gastrointestinal adverse reactions, including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. Reactions can occur at any time without warning symptoms. Elderly patients are at greater risk.

DUEXIS should not be given to patients who have experienced asthma, urticaria or allergic reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylaxis with NSAIDs has been reported in such patients. DUEXIS is contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft surgery. DUEXIS is contraindicated in patients in late stages of pregnancy as premature closure of the ductus arteriosus in the fetus may occur. DUEXIS should not be administered to patients with a history of hypersensitivity to other H2-receptor antagonists. Cross sensitivity with other H2-receptor antagonists has been observed.

When active and clinically significant bleeding from any source occurs in patients receiving DUEXIS, the treatment should be withdrawn.

NSAIDs, including ibuprofen, which is a component of DUEXIS tablets, can lead to onset of new hypertension or worsening of preexisting hypertension, either of which may contribute to the increased incidence of cardiovascular events. Monitor blood pressure closely during treatment with DUEXIS.

Fluid retention and edema have been observed in some patients taking NSAIDs. DUEXIS should be used with caution in patients with fluid retention or heart failure.

Long-term administration of NSAIDs, including ibuprofen, which is a component of DUEXIS tablets, has resulted in renal papillary necrosis and other renal injury. Use DUEXIS with caution in patients at risk (e.g., the elderly; those with renal impairment, heart failure or liver impairment and those taking diuretics or ACE inhibitors).

Hepatic injury ranging from transaminase elevations to liver failure can occur. If clinical signs and symptoms consistent with liver disease develop, if abnormal liver tests persist or worsen or if systemic manifestations occur, DUEXIS should be discontinued immediately.

Anaphylaxis may occur in patients with the aspirin triad or in patients without prior exposure to DUEXIS. If an anaphylactoid reaction occurs, DUEXIS should be discontinued immediately.

Serious skin reactions, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, which can be fatal, can occur. Discontinue DUEXIS if rash or other signs of local skin reaction occur.
Nursing mothers should use DUEXIS with caution, as it is not known if ibuprofen is excreted in human milk, and famotidine is excreted in human milk.

The most common adverse reactions (≥1% and greater than ibuprofen alone) were nausea, diarrhea, constipation, upper abdominal pain and headache.

For further information on DUEXIS, please see full Prescribing Information at www.DUEXIS.com.

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.

Forward-Looking Statements
This press release contains forward-looking statements, including statements regarding the future role of sanofi-aventis as the primary commercial manufacturer of DUEXIS and the launch 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-aventis' ability to comply with on-going regulatory requirements with respect to the Laval facility, whether Horizon's manufacturing agreement with sanofi-aventis will be terminated early, whether each party will be able to satisfy its performance obligations under the manufacturing agreement, Horizon's ability to successfully recruit and retain sales and marketing personnel, and potential delays in commercially launching DUEXIS in the U.S. due to regulatory, manufacturing or operational difficulties, or otherwise. 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.


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Source: Horizon Pharma

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