Horizon Pharma Announces the U.S. Patent and Trademark Office

Horizon Pharma Announces the U.S. Patent and Trademark Office Has
Issued a Notice of Allowance With Claims Covering RAYOS(R)
(Prednisone) Delayed-Release Tablets 
DEERFIELD, IL -- (Marketwire) -- 10/15/12 --  Horizon Pharma, Inc.
(NASDAQ: HZNP) today announced that SkyePharma has received a Notice
of Allowance from the United States Patent and Trademark Office for
U.S. Patent Application 2012/0177734 entitled "Delayed Release Tablet
with Defined Core Geometry" that covers the U.S. approved product
RAYOS(R).  
This Notice of Allowance concludes the substantive examination of the
patent application and will result in the issuance of a U.S. patent
after administrative processes are completed. The patent scheduled to
issue from this application will expire in 2024 for the U.S. patent.
After issuance, Horizon plans to list the U.S. patent in the FDA's
Approved Drug Products with Therapeutic Equivalence Evaluations, or
Orange Book. 
"This patent allowance is a critical expansion of the patent estate
for RAYOS," said Timothy P. Walbert, chairman, president and chief
executive officer of Horizon. "We are focused on protecting the
commercial potential of RAYOS to 2024 and we will begin the RAYOS
commercial launch this quarter." 
About RAYOS 
 RAYOS(R), known as LODOTRA(R) in Europe, is a
proprietary delayed-release formulation of low-dose prednisone which
utilizes SkyePharma's proprietary Geoclock(TM) technology. 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. Given RAYOS
delayed-release profile, this 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. 
On July 26, 2012 the U.S. Food and Drug Administration (FDA) approved
RAYOS(R) 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) (see full prescribing information at
www.RAYOSrx.com).  
Outside the United States, LODOTRA is approved for the treatment of
moderate to severe active RA when accompanied by morning stiffness in
nineteen 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. (NASDAQ: HZNP) 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 the
issuance of a patent based on the notice of allowance from the U.S.
Patent and Trademark Office, the ability to protect the commercial
potential of RAYOS to 2024 and the planned timing of commercial
launch of RAYOS. 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.
These factors include risks regarding whether the administrative
processes required for the issuance of a patent as indicated in the
notice of allowance will be completed in a timely matter or at all,
whether the patent, if issued as indicated in the notice of
allowance, will provide sufficient protection and market exclusivity
for RAYOS, whether any patent issued to Horizon may be challenged,
invalidated, infringed or circumvented by third parties and other
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 undertakes no obligation to update or revise these
statements, except as may be required by law.  
Contacts
Robert J. De Vaere
Executive Vice President, Chief Financial Officer
investor-relations@horizonpharma.com 
Investors
Kathy Galante
Burns McClellan, Inc.
212-213-0006
kgalante@burnsmc.com 
 
 
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