Horizon Pharma Receives Marketing Authorization for DUEXIS(R) From the United
Kingdom Medicines and Healthcare Products Regulatory
DEERFIELD, IL -- (Marketwire) -- 03/07/13 -- Horizon Pharma, Inc.
(NASDAQ: HZNP) today announced that the United Kingdom (UK) Medicines
and Healthcare products Regulatory Agency (MHRA) has granted
marketing authorization for DUEXIS(R) (ibuprofen/famotidine) for the
symptomatic treatment of osteoarthritis, rheumatoid arthritis and
ankylosing spondylitis in patients who require regular treatment with
high dose ibuprofen administered three times a day and who are at
risk of developing non-steroidal anti-inflammatory drug (NSAID)
associated gastric and/or duodenal ulcers. Horizon is seeking to
license rights to DUEXIS in Europe to one or more commercial
"We are pleased that the UK health authority has granted marketing
authorization, which we believe further validates DUEXIS as an
important treatment option for patients with osteoarthritis,
rheumatoid arthritis and ankylosing spondylitis," said Todd N. Smith,
executive vice president, chief commercial officer, Horizon Pharma.
"We are seeking a potential commercial partner or partners for DUEXIS
in the UK and the rest of Europe. However, given the current state of
the arthritis m
arket in Europe and the revenue being generated there
by existing branded NSAIDs, we expect the U.S. market, where DUEXIS
continues to gain traction, to continue to represent the most
significant opportunity for Horizon."
DUEXIS, a proprietary single-tablet combination of the
NSAID ibuprofen and the histamine H2-receptor antagonist famotidine,
is indicated in the U.S. for the relief of signs and symptoms of
rheumatoid arthritis and osteoarthritis and to decrease the risk of
developing upper gastrointestinal ulcers, which in the clinical
trials was defined as a gastric and/or duodenal ulcer, in patients
who are taking ibuprofen for those indications. The clinical trials
primarily enrolled patients less than 65 years of age without a prior
history of gastrointestinal ulcer. Controlled trials do not extend
beyond 6 months. For more information, please visit www.DUEXIS.com.
Important safety information
Risk of Serious Cardiovascular and Gastrointestinal Events
See full Prescribing Information for complete boxed warning
(according to the U.S. FDA approval)
Ibuprofen, a component of DUEXIS, may increase the risk of serious
cardiovascular thrombotic events, myocardial infarction, and stroke,
which can be fatal. Risk may increase with duration of use. Patients
with cardiovascular disease or risk factors for cardiovascular
disease may be at greater risk.
DUEXIS is contraindicated for the treatment of perioperative pain in
the setting of coronary artery bypass graft surgery.
Nonsteroidal anti-inflammatory drugs (NSAIDs), including ibuprofen, a
component of DUEXIS, increase the risk of serious gastrointestinal
adverse reactions, including bleeding, ulceration and perforation of
the stomach or intestines, which can be fatal. Reactions can occur at
any time without warning symptoms. Elderly patients are at greater
DUEXIS should not be given to patients who have experienced asthma,
urticaria or allergic reactions after taking aspirin or other NSAIDs.
Severe, rarely fatal, anaphylaxis with NSAIDs has been reported in
such patients. DUEXIS is contraindicated for the treatment of
perioperative pain in the setting of coronary artery bypass graft
surgery. DUEXIS is contraindicated in patients in late stages of
pregnancy as premature closure of the ductus arteriosus in the fetus
may occur. DUEXIS should not be administered to patients with a
history of hypersensitivity to other H2-receptor antagonists. Cross
sensitivity with other H2-receptor antagonists has been observed.
When active and clinically significant bleeding from any source
occurs in patients receiving DUEXIS, the treatment should be
NSAIDs, including ibuprofen, which is a component of DUEXIS tablets,
can lead to onset of new hypertension or worsening of preexisting
hypertension, either of which may contribute to the increased
incidence of cardiovascular events. Monitor blood pressure closely
during treatment with DUEXIS.
Fluid retention and edema have been observed in some patients taking
NSAIDs. DUEXIS should be used with caution in patients with fluid
retention or heart failure.
Long-term administration of NSAIDs, including ibuprofen, which is a
component of DUEXIS tablets, has resulted in renal papillary necrosis
and other renal injury. Use DUEXIS with caution in patients at risk
(e.g., the elderly; those with renal impairment, heart failure or
liver impairment and those taking diuretics or ACE inhibitors).
Hepatic injury ranging from transaminase elevations to liver failure
can occur. If clinical signs and symptoms consistent with liver
disease develop, if abnormal liver tests persist or worsen or if
systemic manifestations occur, DUEXIS should be discontinued
Anaphylaxis may occur in patients with the aspirin triad or in
patients without prior exposure t
o DUEXIS. If an anaphylactoid
reaction occurs, DUEXIS should be discontinued immediately.
Serious skin reactions, including exfoliative dermatitis,
Stevens-Johnson syndrome and toxic epidermal necrolysis, which can be
fatal, can occur. Discontinue DUEXIS if rash or other signs of local
skin reaction occur.
Nursing mothers should use DUEXIS with caution, as it is not known if
ibuprofen is excreted in human milk and famotidine is excreted in
The most common adverse reactions (≥1% and greater than
ibuprofen alone) were nausea, diarrhea, constipation, upper abdominal
pain and headache.
For further information on DUEXIS, please see full Prescribing
Information at www.DUEXIS.com.
Osteoarthritis (OA) is a degenerative joint
disease caused by the breakdown and eventual loss of the cartilage of
one or more joints. It is the most common form of arthritis and the
most common cause of chronic pain, affecting an estimated 27 million
individuals in the U.S. Worldwide, an estimated 9.6% of men and 18%
of women 60 years of age and older have symptomatic OA.
OA is caused by various factors, including older age, being
overweight, joint injury or stress, heredity and muscle weakness. OA
commonly affects the hands, spine or large weight-bearing joints,
such as the hips and knees.
About Rheumatoid Arthritis
Rheumatoid Arthritis (RA) is a chronic
disease that causes pain, stiffness and swelling, primarily in the
joints. RA affects approximately 1.8 million people in the U.S. and
is not associated with factors such as aging. Worldwide, RA has an
estimated prevalence of 0.3 to 1% of the total adult population.
RA occurs when the body's immune system malfunctions, attacking
healthy tissue and causing inflammation, which leads to pain and
swelling in the joints and may eventually cause permanent joint
damage and painful disability. The primary symptoms of RA include
progressive immobility and pain, especially in the morning, with
long-term sufferers experiencing continual joint destruction for the
remainder of their lives.
About Ankylosing Spondylitis
Ankylosing spondylitis (AS) is a
chronic, progressive, connective tissue disorder that is
characterized by inflammation of the joints of the spine (vertebral
joints), hipbones, and sacrum (sacroiliac joints). Symptoms of AS are
similar to those of RA, including pain, swelling and stiffness in the
affected joints. The disorder differs from RA in that spondylitis
primarily affects the spine, forming bony outgrowths (syndesmophytes)
between the vertebrae, which may fuse vertebrae and lead to total
spinal immobility (ankylosis). The worldwide annual incidence of AS
is estimated to be up to 7.3 per 100,000 individuals. DUEXIS is not
approved for the treatment of AS in the United States.
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
Forward Looking Statements
This press release contains
forward-looking statements, including statements regarding Horizon's
plans to find commercial partners for DUEXIS in Europe and
expectations of market opportunities for DUEXIS. 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 Horizon's ability to commercialize products successfully or
to find partners to help it commercialize its products in Europe. 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 and Horizon undertakes no obligation to update or revise
these statements, except as may be required by law.
Robert J. De Vaere
Executive Vice President and Chief Financial Officer
Burns McClellan, Inc.
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