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Horizon Pharma Announces Availability of Horizon-Labeled VIMOVO(R) in the United States

Horizon Pharma Announces Availability of Horizon-Labeled VIMOVO(R) in the 
United States 
DEERFIELD, IL -- (Marketwired) -- 01/02/14 --  Horizon Pharma, Inc.
(NASDAQ: HZNP) today announced that Horizon-labeled VIMOVO(R)
(naproxen/esomeprazole magnesium) delayed-release tablets are now
available to U.S. physicians. VIMOVO is approved for the relief of
signs and symptoms of osteoarthritis (OA), rheumatoid arthritis (RA)
and ankylosing spondylitis and to decrease the risk of stomach
(gastric) ulcers in patients at risk of developing stomach ulcers
from treatment with NSAIDs. VIMOVO is a proprietary fixed-dose
combination of enteric-coated naproxen, a pain-relieving
non-steroidal anti-inflammatory drug (NSAID) and immediate-release
esomeprazole, a proton pump inhibitor (PPI). The Company expects to
begin the commercial launch of Horizon-labeled VIMOVO with its
primary care sales force on February 3, 2014. 
"The availability of Horizon-labeled VIMOVO is a major milestone for
us as we plan for our full commercial launch. We expect to complete
hiring and training our expanded sales force this month and commence
our launch of VIMOVO in early February," stated Timothy P. Walbert,
chairman, president and chief executive officer, Horizon Pharma.
"Effective today, VIMOVO is now available via our co-pay program and
is also included in our Prescriptions-Made-Easy(TM) specialty
pharmacy program, ensuring VIMOVO is available at a reasonable
out-of-pocket cost to patients." 
According to the Arthritis Foundation, more than 50 million adults
(one in every five) in the U.S. have doctor diagnosed arthritis.
Arthritis prevalence increases with age with 50 percent of adults age
65 and older having some form of arthritis. By the year 2030, an
estimated 67 million American adults will have arthritis. 
NSAIDs are effective at providing pain and inflammation relief
associated with OA and RA; however, there are significant upper
GI-associated adverse events which can result from such treatments
and patients with OA and RA taking NSAIDs are at increased risk for
upper GI ulcers. 
VIMOVO was approved by the FDA in April 2010, supported by data from
two pivotal studies in which patients received either VIMOVO or
enteric-coated naproxen 500 mg, twice daily, over a six-month
treatment period. Da
ta from one study (PN400-301) showed a 4.1%
incidence of gastric ulcers in patients taking VIMOVO, compared to
23.1% among patients taking enteric-coated naproxen (p < 0.001). A
second study (PN400-302) showed a 7.1% incidence of gastric ulcers
among patients taking VIMOVO, compared to 24.3% with enteric-coated
naproxen (p < 0.001). Endoscopies were performed at baseline and at
one, three and six months. The safety of VIMOVO was evaluated in
clinical studies involving 2,317 patients (aged 27 to 90 years) and
ranging from 3-12 months. The most commonly observed adverse events
in the clinical trials (experienced by > 5% of patients in the VIMOVO
group) were erosive gastritis, dyspepsia, gastritis, diarrhea,
gastric ulcer, upper abdominal pain and nausea. 
About Horizon Pharma 
Horizon Pharma, Inc. is a commercial stage, specialty pharmaceutical
company that markets DUEXIS(R), RAYOS(R)/LODOTRA(R) and VIMOVO(R),
which target unmet therapeutic needs in arthritis, pain and
inflammatory diseases. The Company's strategy is to develop, acquire
or in-license additional innovative medicines where it can execute a
targeted commercial approach among specific target physicians such as
primary care physicians, orthopedic surgeons, and rheumatologists,
while taking advantage of its commercial strengths and the
infrastructure the Company has put in place. For more information,
please visit www.horizonpharma.com. 
About VIMOVO 
VIMOVO(R) (naproxen / esomeprazole magnesium) is a proprietary
fixed-dose combination of delayed-release enteric-coated naproxen, a
non-steroidal anti-inflammatory drug (NSAID) and immediate-release
esomeprazole, a stomach acid-reducing proton pump inhibitor (PPI),
approved for the relief of signs and symptoms of osteoarthritis,
rheumatoid arthritis and ankylosing spondylitis and to decrease the
risk of developing gastric ulcers in patients at risk of developing
NSAID-associated gastric ulcers. VIMOVO is not recommended for use in
children younger than 18 years of age. VIMOVO is not recommended for
initial treatment of acute pain because the absorption of naproxen is
delayed compared to absorption from other naproxen-containing
products. Controlled studies do not extend beyond 6 months. VIMOVO
should be used at the lowest dose and for the shortest amount of time
as directed by a health care provider. 
For Full Prescribing Information see www.VIMOVO.com. 
Forward Looking Statements 
This press release contains forward-looking statements, including
statements regarding Horizon's plans and expectations with respect to
its commercialization of VIMOVO in the United States, including the
planned increase in its field sales force and the timing of its
commercial launch of VIMOVO in the United States, and expected
increases in the prevalence of arthritis in the United States. 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, but are not
limited to, risks regarding Horizon's ability to commercialize its
products successfully, Horizon's ability to successfully hire and
manage sales and marketing personnel, Horizon's ability to comply
with post-approval regulatory requirements, and the outcome of
on-going and potential future patent litigation with respect to
Horizon's products, including VIMOVO. For a further description of
these and other risks facing the Company, please see the risk factors
described in the Company'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 the Company
undertakes no obligation to update or revise these statements, except
as may be required by law. 
Contacts
Investors
Robert J. De Vaere
Executive Vice President, Chief Financial Officer
investor-relations@horizonpharma.com 
 
 
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