Horizon Pharma Announces Sanofi Compiegne as Additional Manufacturing Site for
DEERFIELD, IL -- (Marketwired) -- 09/05/13 -- Horizon Pharma, Inc.
(NASDAQ: HZNP) today announced that the United States Food and Drug
Administration has approved the use of Sanofi's manufacturing site in
Compiegne, France to manufacture DUEXIS(R) (ibuprofen/famotidine), a
proprietary single-tablet combination of ibuprofen (800 mg) and
famotidine (26.6 mg). Valeant Pharmaceuticals' manufacturing site in
Laval, Quebec, previously owned and operated by Sanofi, serves as the
primary commercial manufacturing site for DUEXIS.
"We have had a successful long-term partnership with Sanofi and are
pleased with the FDA's approval of the Compiegne site as an
additional manufacturing facility for DUEXIS," said Hans-Peter Zobel,
Ph.D., senior vice president, manufacturing, Horizon Pharma. "This
approval provides us a quality backup manufacturing site, enhancing
our ability to ensure an adequate long-term supply of DUEXIS."
DUEXIS, a proprietary single-tablet combination of the
NSAID ibuprofen and the histamine H2-receptor antagonist famotidine,
is indicated 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.
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 and in-license 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 www.horizonpharma.com.
This press release contains
forward-looking statements, including statements regarding Horizon's
ability to ensure an adequate long-term supply of 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. These factors include, but are not
limited to, risks regarding Sanofi's ability to comply with on-going
regulatory requirements with respect to the Compiegne facility,
whether Horizon's manufacturing agreement with Sanofi will be
terminated early and whether each party will be able to satisfy its
performance obligations under the manufacturing agreement. 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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