Horizon Pharma to Receive Approval of DUEXIS(R) From the United
Kingdom (UK) Medicines and Healthcare Products Regulatory Agency
DEERFIELD, IL -- (Marketwire) -- 12/21/12 -- Horizon Pharma, Inc.
(NASDAQ: HZNP) today announced that the United Kingdom (UK) Medicines
and Healthcare products Regulatory Agency (MHRA), based on the
favorable recommendation of their Commission on Human Medicines
(CHM), will grant a Marketing Authorization (MA) for DUEXIS(R)
(ibuprofen/famotidine), pending review of updated licensing documents
which the Company has provided to the MHRA. The MA of DUEXIS is for
the treatment of osteoarthritis (OA), rheumatoid arthritis (RA) and
ankylosing spondylitis (AS) and to decrease the risk of developing
upper gastrointestinal ulcers. DUEXIS is approved and available in
the United States.
The positive decision from the MHRA is the final regulatory step for
DUEXIS to be marketed in the UK. The Company anticipates that
granting of the UK Marketing Authorization for DUEXIS will facilitate
progressive approval of the product in additional EU Member States
through the Mutual Recognition Procedure under EU pharmaceutical law.
Under this procedure, the UK will act as the Reference Member State.
"The approval of DUEXIS in the UK is the first step in gaining broad
approval across Europe," said Timothy P. Walbert, chairman, president
and chief executive officer, Horizon Pharma. "We will be seeking a
potential commercial partner in the UK and other EU Member States
where DUEXIS may be approved. Our primary focus remains in the U.S.
where we believe the vast majority of the global NSAID market
Horizon originally submitted its Marketing Authorization Application
(MAA) in October 2010 to the MHRA through the Decentralized
Procedure, with the UK as the Reference Member State. The Company
subsequently modified the MAA submission in February 2012 to include
the facility that serves as the primary manufacturing site for
DUEXIS, a proprietary single-tablet fixed dose
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 g
astrointestinal 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
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 to 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
bility 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.
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.
This press release contains
forward-looking statements, including statements regarding the
expected grant of a Marketing Authorization for DUEXIS, potential
approval of DUEXIS in additional EU Member States and the Company's
plans to find commercial partners for DUEXIS in the UK or other EU
Member States where DUEXIS may be approved. 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 gain final marketing approval for DUEXIS in
the UK or other EU Member States and the Company's ability to
commercialize products successfully or to find partners to help it
commercialize its products in the EU. 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.
Burns McClellan, Inc.
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