Horizon Pharma Announces Clinical Data on RAYOS(R) (Prednisone) Delayed-Release Tablets to Be Presented at the American College of Rheumatology Annual Meeting

Horizon Pharma Announces Clinical Data on RAYOS(R) (Prednisone) Delayed-Release Tablets to Be Presented at the American College of Rheumatology Annual Meeting


DEERFIELD, IL -- (Marketwire) -- 11/05/12 -- Horizon Pharma, Inc. (NASDAQ: HZNP) today announced that two studies on its recently approved treatment RAYOS® 5 mg (prednisone) delayed-release tablets will be presented during the American College of Rheumatology (ACR)/Association of Rheumatology Health Professionals (ARHP) Annual Scientific Meeting, November 9-14 in Washington, D.C.

RAYOS Abstracts to be Presented

  • Improved Fatigue-Related Quality of Life in CAPRA-2, a 12 Week Study of 5 mg Modified (Delayed) Release Prednisone in Rheumatoid Arthritis (Alten, et. al.)
    • Author: Rieke Alten, M.D., chief of the Internal Medicine Division, Schlosspark Clinic, Berlin
    • Session: Rheumatoid Arthritis - Clinical Aspects I: Drug Studies/Drug Safety/Drug Utilization/Disease Activity & Remission
    • Sunday, November 11, 9 a.m. - 6 p.m.
    • Presentation Number: 367

  • Relationship Between Morning Stiffness Duration and Severity, Pain Intensity, and Measures of Disease Activity in a 12 Week Efficacy Study of a Modified (Delayed-Release) Prednisone Plus Disease-Modifying Antirheumatic Drugs in Rheumatoid Arthritis (Buttgereit, et. al.)
    • Author: Frank Buttgereit, M.D., senior consultant and deputy head of the Department of Rheumatology and Clinical Immunology, Charité Hospital, Berlin
    • Session: Rheumatoid Arthritis Treatment - Small Molecules, Biologics and Gene Therapy
    • Monday, November 12, 9 a.m. - 6 p.m.
    • Presentation Number: 1274

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 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.

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 16 European countries and Israel. Horizon has granted commercialization rights for LODOTRA in Europe, Asia and Latin America to its distribution partner Mundipharma International Corporation Limited. Horizon has an exclusive license from SkyePharma for RAYOS.

Important Safety Information

RAYOS® (prednisone) delayed-release tablets

Approved uses of 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 rheumatoid arthritis (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.com.

RAYOS 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 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
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.


Kathy GalanteBurns McClellan, Inc.


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Source: Horizon Pharma

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