DEERFIELD, IL — (Marketwired) — 08/22/13 — Horizon Pharma, Inc. (NASDAQ: HZNP) today announced that it has entered into settlement and license agreements with Par Pharmaceutical Companies, Inc. and its subsidiary Par Pharmaceutical, Inc., to resolve pending patent litigation involving DUEXIS® (ibuprofen and famotidine) tablets.
Under the license agreement, Horizon has granted Par the non-exclusive right to market a generic ibuprofen and famotidine product in the U.S. under Par’s Abbreviated New Drug Application (ANDA), beginning January 1, 2023, or earlier under certain circumstances. Currently, Horizon has listed six Orange Book patents covering DUEXIS.
The settlement agreement includes a stipulation by the parties requesting dismissal without prejudice of the lawsuit filed by Horizon in the U.S. District Court for the District of Delaware relating to the ANDA filed by Par with the U.S. Food and Drug Administration for a generic version of DUEXIS (ibuprofen and famotidine) tablets.
Details of the settlement are confidential, and the agreements are subject to submission to the Federal Trade Commission and the U.S. Department of Justice. The settlement and license agreements will become effective upon the entry by the U.S. District Court for the District of Delaware of an order dismissing without prejudice the litigation with respect to Par.
“We believe this settlement validates the innovation and breadth of the DUEXIS patent portfolio,” said Timothy P. Walbert, chairman, president and chief executive officer, Horizon Pharma. “DUEXIS offers important potential advantages to patients suffering from osteoarthritis who are at risk of developing upper gastrointestinal ulcers and we look forward to many years of continued growth.”
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.
Important Safety Information About DUEXIS
DUEXIS is not right for everyone. People who have had asthma, hives, or an allergic reaction to aspirin or other NSAIDs should not take DUEXIS. Women in the late stages of pregnancy should not take DUEXIS. People who have had allergic reactions to medications like famotidine (histamine H2‐receptor antagonists) should not take DUEXIS.
Tell your health care provider right away if you have signs of active bleeding (persistent and unexplained) while you are taking DUEXIS.
NSAID‐containing medications like DUEXIS can cause high blood pressure or make existing high blood pressure worse, either of which can increase the chance of a heart attack or stroke. Your health care provider should check your blood pressure while you are taking DUEXIS.
Before you start taking DUEXIS, tell your health care provider if you have heart problems, kidney problems, liver problems or if you are taking medications for high blood pressure. DUEXIS can increase the chance of potentially significant liver injury and/or kidney injury, which may be fatal. Stop taking DUEXIS immediately and contact your health care provider if you experience any signs and/or symptoms of liver or kidney injury.
Serious allergic reactions, including skin reactions, can happen without warning and can be life threatening. Stop taking DUEXIS and consult your doctor immediately if you get a skin rash or if you start to have problems breathing or swallowing or if you develop swelling of your face or throat.
The most common side effects of DUEXIS include nausea, diarrhea, constipation, upper abdominal pain and headache.
Please see Medication Guide and full Prescribing Information, available at 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, in-license and/or co-promote additional innovative medicines where it can execute a targeted commercial strategy 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 the anticipated results or benefits of the settlement and license agreements with Par, the entry by the U.S. District Court for the District of Delaware of an order dismissing the litigation with respect to Par’s ANDA filing, and anticipated growth of DUEXIS sales. 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 whether the U.S. Federal Trade Commission or Department of Justice challenge the enforceability of or seek to enjoin the entry into the settlement and license agreements, whether the U.S. District Court will grant an order dismissing the litigation, whether additional third parties may seek to market generic versions of DUEXIS by filing ANDAs with the FDA and the results of any litigation that Horizon files to defend and/or assert its patents against such third parties, the occurrence of events under the license agreement that would allow Par to market its generic version of DUEXIS earlier than anticipated, Horizon’s ability to commercialize products successfully, the impact of pricing decisions on product revenues, Horizon’s ability to successfully manage contract sales and marketing personnel, Horizon’s ability to comply with post-approval regulatory requirements and the need to potentially obtain additional financing to successfully commercialize or further develop DUEXIS. 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.