SOURCE: Horizon Pharma plc

Horizon Pharma plc

October 02, 2015 07:00 ET

Horizon Pharma plc Announces Settlement of RAYOS® (prednisone) Delayed-Release Tablets Patent Litigation With Actavis Laboratories FL Inc.

DUBLIN, IRELAND--(Marketwired - Oct 2, 2015) - Horizon Pharma plc (NASDAQ: HZNP), a biopharmaceutical company focused on improving patients' lives by identifying, developing, acquiring and commercializing differentiated and accessible medicines that address unmet medical needs, today announced that its affiliate Horizon Pharma Switzerland GmbH has entered into a settlement and license agreement with Actavis Laboratories FL, Inc. ("Actavis") to resolve pending patent litigation involving RAYOS® (prednisone) Delayed-Release Tablets.

Under the settlement and license agreement, Horizon has granted Actavis the right to market a version of delayed-release prednisone tablets in the United States under the Actavis Abbreviated New Drug Application (ANDA), beginning December 23, 2022 or earlier under certain circumstances. 

The agreement includes a stipulation by the parties requesting dismissal with prejudice of the lawsuit filed by Horizon in the U.S. District Court for the District of New Jersey and relating to the ANDA filed by Actavis with the U.S. Food and Drug Administration for a version of delayed-release prednisone tablets.

Details of the settlement are confidential and the agreement is subject to submission to the Federal Trade Commission and the U.S. Department of Justice. 

"This RAYOS patent estate is strong and we will continue to defend patent challenges in order to protect our innovation and ensure continued patient access," said Timothy P. Walbert, chairman, president and chief executive officer, Horizon Pharma plc.

About RAYOS
RAYOS, known as LODOTRA® in Europe, is a proprietary delayed-release formulation of low-dose prednisone. The pharmacokinetic profile of RAYOS is different with an approximately four-hour lag time from that of immediate-release prednisone formulations. In clinical trials studying use of RAYOS in rheumatoid arthritis (RA), patients were administered RAYOS at 10 p.m. with food. The delayed-release profile of RAYOS helps to achieve therapeutic prednisone blood levels at a time point when cytokine levels start rising during the middle of the night. While the pharmacokinetic profile of RAYOS differs in terms of lag time from immediate-release prednisone, its absorption, distribution and elimination processes are comparable. For more information, please visit www.RAYOSrx.com.

RAYOS utilizes Skyepharma's proprietary Geoclock™ technology.

Outside the United States, LODOTRA is approved for the treatment of moderate to severe active RA when accompanied by morning stiffness in over thirty-five countries. Horizon has granted commercialization rights for LODOTRA in Europe, Asia (excluding Japan) and Latin America to its distribution partner Mundipharma International Corporation Limited. Horizon has an exclusive license from Skyepharma for RAYOS/LODOTRA.

Approved Uses for RAYOS
RAYOS, a delayed-release form of prednisone, prevents the release of substances in the body that cause inflammation. RAYOS is approved to treat a broad range of diseases including RA, polymyalgia rheumatica (PMR), psoriatic arthritis (PsA), ankylosing spondylitis (AS), asthma and chronic obstructive pulmonary disease (COPD). For a full list of RAYOS indications, please see full prescribing information at www.RAYOSrx.comRAYOS is contraindicated in patients who have known hypersensitivity to prednisone or to any of the excipients. Rare instances of anaphylaxis have occurred in patients receiving corticosteroids.

Important Safety Information about RAYOS
Do not use RAYOS if you are allergic to prednisone. Long-term use of RAYOS can affect how your body responds to stress. Symptoms can include weight gain, severe fatigue, weak muscles and high blood sugar. RAYOS can weaken your immune system, making it easier for you to get an infection or worsening an infection you already have or have recently had. RAYOS can cause high blood pressure, salt and water retention and low blood potassium. There is an increased risk of developing holes in the stomach or intestines if you have certain stomach and intestinal disorders. Behavior and mood changes can occur, including intense excitement or happiness, sleeplessness, mood swings, personality changes or severe depression.

Long-term use of RAYOS can cause decreases in bone density. RAYOS can cause cataracts, eye infections and glaucoma. Do not receive a "live" vaccine while taking RAYOS. The vaccine may not work as well during this time and may not fully protect you from disease. Taking RAYOS during the first trimester of pregnancy can harm an unborn baby. Long-term use of RAYOS can slow growth and development in children.

The most common side effects with RAYOS are water retention, high blood sugar, high blood pressure, unusual behavior and mood changes, increased appetite and weight gain. Please see full prescribing information for RAYOS at www.RAYOSrx.com.

About Horizon Pharma plc
Horizon Pharma plc is a biopharmaceutical company focused on improving patients' lives by identifying, developing, acquiring and commercializing differentiated and accessible medicines that address unmet medical needs. The Company markets seven medicines through its orphan, primary care and specialty business units. Horizon's global headquarters are in Dublin, Ireland. For more information, please visit www.horizonpharma.com. Follow @HZNPplc on Twitter or view careers on our LinkedIn page.

Forward-Looking Statements
This press release contains forward-looking statements, including statements regarding the anticipated results or benefits of the settlement and license agreement for RAYOS and the strength of the Company's patent estate. These forward-looking statements are based on management 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 will challenge the enforceability of or seek to enjoin the entry into the settlement and license agreement, whether the U.S. District Court will grant an order dismissing the litigation, whether additional third parties may seek to market generic versions of RAYOS by filing ANDAs with the FDA and the results of any litigation that Horizon files to defend or assert its patents against such third parties, the occurrence of events under the settlement and license agreement that would allow Actavis Laboratories FL Inc. to market its generic version of RAYOS earlier than anticipated, Horizon's ability to commercialize products successfully and Horizon's ability to execute on its plan to grow through acquiring or in licensing additional products or companies and other 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 does not undertake any obligation to update or revise these statements, except as may be required by law.

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