Horizon Pharma Begins Initial Commercial Launch of RAYOS(R)

Horizon Pharma Begins Initial Commercial Launch of RAYOS(R)
(prednisone) Delayed-Release Tablets in the United States 
DEERFIELD, IL -- (Marketwire) -- 12/03/12 --  Horizon Pharma, Inc.
(NASDAQ: HZNP) today announced that RAYOS(R) (prednisone) delayed
release tablets are now available to U.S. physicians 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). The
focus of the commercial launch will be in rheumatologic diseases,
such as RA and PMR. The Company will initially target approximately
one thousand rheumatologists in the U.S. with thirteen rheumatology
sales specialists. The full launch to the majority of U.S.
rheumatologists and high-value primary care physicians with Horizon's
entire sales force of approximately one hundred fifty representatives
will begin in late January 2013. 
"The commercial launch of RAYOS further affirms our commitment to
provide innovative therapeutic options to patients who suffer from
arthritis, pain and inflammatory diseases and to the physicians who
treat them," said Todd Smith, executive vice president and chief
commercial officer, Horizon Pharma. "Our near term focus is on
top-tier rheumatologists to prepare the market for the full
rheumatology and primary care launch in late January 2013." 
In July of this year, the U.S. Food and Drug Administration (FDA)
approved Horizon's new drug application (NDA) for RAYOS. The FDA
approval was supported by data bridging the pharmacokinetics of RAYOS
to immediate-release prednisone and data from the Circadian
Administration of Prednisone in RA (CAPRA-1 and 2) trials. The
CAPRA-2 trial demonstrated that people with moderate to severe RA
treated with RAYOS experienced a statistically significant
improvement in ACR20 response criteria compared to placebo in
addition to their non-biologic disease-modifying antirheumatic drug
(DMARD) therapy. The CAPRA-1 trial supported the overall safety of
RAYOS. 
Specific results from CAPRA-2 demonstrated: 


 
--  A statistically significant improvement in ACR20 response criteria,
    the primary study endpoint, for patients who were treated with RAYOS
    compared to the placebo group (47% vs. 29%; p-value = 0.001).
--  A statistically significant improvement in ACR50 response compared to
    placebo (22% vs. 10%; p-value = 0.007) and an improvement in the more
    stringent ACR70 response criteria (7% vs. 3%; p-value = 0.0984). Both
    ACR50 and ACR70 were pre-specified secondary endpoints.
--  The relative change from baseline in the duration of morning stiffness
    at 12 weeks was assessed as a pre-specified secondary endpoint.
    Patients treated with RAYOS had a median decrease in the duration of
    morning stiffness of 55 minutes compared to 33 minutes in
    placebo-treated patients (20 minute estimated median difference
    between treatment groups with 95% confidence interval [7, 32; p-value
    = 0.001]).

  
Results from CAPRA-2 were published online in Annals of the Rheumatic
Diseases (doi:10.1136/annrheumdis-2011-201067) on May 5, 2012. 
The safety of RAYOS was based on the evaluation of 375 RA patients in
two controlled trials. Patients treated with RAYOS ranged in age from
20 to 80 years (median age 56 years). Patients were predominantly
Caucasian and 85 percent were female.  
Included in these safety results were data from the CAPRA-1 trial, a
12-week, double-blind, randomized controlled study that evaluated 288
RA patients. CAPRA-1 compared 10 p.m. administration of RAYOS with
the morning administration of immediate-release prednisone at the
same individual dose (average dose of 6.7 mg). Following the 12-week
CAPRA-1 study, patients were followed in a 9-month, open-label
extension study, which included 249 RA patients, 219 of whom
completed the extension study. Patients received RAYOS 3 mg to 10 mg
once daily at 10 p.m.; the majority (84 percent) received 5 mg or
less.  
The clinical trial experience did not raise any safety concerns
beyond those already established for immediate-release prednisone.  
Results from the CAPRA-1 12-week study and the 9-month open-label
extension have been published in The Lancet and Annals of the
Rheumatic Diseases, respectively. 
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. For more information, please visit www.RAYOSrx.com. 
RAYOS utilizes SkyePharma's proprietary Geoclock(TM) technology under
an exclusive license from SkyePharma.  
Outside the U.S., LODOTRA is approved in 19 countries for the
treatment of moderate to severe active RA when accompanied by morning
stiffness. Horizon has granted commercialization rights for LODOTRA
in Europe, Asia (excluding Japan) and Latin America to its
distribution partner Mundipharma International Corporation Limited. 
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 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. 
Forward-Looking Statements 
This press release contains forward-looking statements, including
statements regarding Horizon's commercialization plans for RAYOS and
the timing for implementing those plans. 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, including, but not limited to, risks regarding
the company's ability to commercialize products successfully,
potential delays or changes in strategy for the commercial launch of
RAYOS, whether physicians will prescribe and patients will use RAYOS
and competition in the market for RAYOS. For a further description of
these and other risks facing Horizon, please see the 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. Horizon undertakes
no obligation to update or revise these statements, except as may be
required by law. 
Contacts:
Todd N. Smith
Executive Vice President, Chief Commercial Officer
investor-relations@horizonpharma.com 
Kathy Galante
Burns McClellan, Inc.
212-213-0006
kgalante@burnsmc.com 
 
 
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