Horizon Pharma Announces Clinical Data on RAYOS(R) (Prednisone)

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(R) 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,
        Charite Hospital, Berlin
    --  Session: Rheumatoid Arthritis Treatment - Small Molecules,
        Biologics and Gene Therapy
    --  Monday, November 12, 9 a.m. - 6 p.m.
    --  Presentation Number: 1274

  
About RAYOS 
 RAYOS, known as LODOTRA(R) 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(TM) 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(R) (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. 
Contact
Kathy Galante
Burns McClellan, Inc.
212-213-0006
kgalante@burnsmc.com 
 
 
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