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

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 -- (Marketwired) -- 10/21/13 --  Horizon Pharma, Inc
(NASDAQ: HZNP) today announced that two published abstracts of its
approved treatment RAYOS(R) (prednisone) delayed-release tablets will
be presented during the American College of Rheumatology
(ACR)/Association of Rheumatology Health Professionals (ARHP) Annual
Scientific Meeting, October 25-30, 2013 in San Diego, CA. 
RAYOS Abstracts to be Presented 


 
--  Threshold Analysis of Patient Reported Morning Stiffness Where
    Delayed-Release (DR) Prednisone Was Compared to, and Replaced,
    Immediate Release Prednisone in Rheumatoid Arthritis (RA) Patients
    Receiving Conventional Disease-Modifying Antirheumatic Drugs (DMARDs)
    Over 1 Year
    --  Lead Author: Frank Buttgereit, M.D., Senior Consultant and Deputy
        Head of the Department of Rheumatology and Clinical Immunology,
        Charite Hospital, Berlin
    --  Session: Rheumatoid Arthritis - Clinical Aspects Poster III:
        Outcome Measures, Socioeconomy, Screening, Biomarkers in
        Rheumatoid Arthritis
    --  Tuesday, October 29, 2013: 8:30 AM-4:00 PM
    --  Presentation Number: 2255
    --  https://ww2.rheumatology.org/apps/MyAnnualMeeting/Abstract/32990

 
--  Switching From Immediate Release (IR) Prednisone to Delayed Release
    (DR) Prednisone Improves Patient Reported Outcomes In Rheumatoid
    Arthritis (RA) Patients On Conventional Disease-Modifying
    Antirheumatic Drugs (DMARDs)
    --  Lead Author: Rieke Alten, M.D., Chief of the Internal Medicine
        Division, Schlosspark Clinic, Berlin
    --  Session: Rheumatoid Arthritis - Clinical Aspects Poster III:
        Outcome Measures, Socioeconomy, Screening, Biomarkers in
        Rheumatoid Arthritis
    --  Tuesday, October 29, 2013: 8:30 AM-4:00 PM
    --  Presentation Number: 2265
    --  https://ww2.rheumatology.org/apps/MyAnnualMeeting/Abstract/34567

  
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 t
hat 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
over 30 countries. 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 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 approach 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. 
Contacts
Robert J. De Vaere
Executive Vice President and Chief Financial Officer
investor-relations@horizonpharma.com  
Investors
Kathy Galante
Burns McClellan, Inc.
212-213-0006
kgalante@burnsmc.com 
 
 
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