Horizon Pharma Announces Receipt of Additional U.S. Patent Allowance for
DEERFIELD, IL -- (Marketwire) -- 02/05/13 -- Horizon Pharma, Inc.
(NASDAQ: HZNP) today announced that it has received a Notice of
Allowance from the United States Patent and Trademark Office (USPTO)
for U.S. Patent Application Serial No. 13/620,150 entitled "Stable
Compositions of Famotidine and Ibuprofen" with claims that cover
DUEXIS(R) (ibuprofen and famotidine) tablets. DUEXIS is indicated for
the relief of signs and symptoms of rheumatoid arthritis and
osteoarthritis and to decrease the risk of developing upper
"This additional Notice of Allowance for DUEXIS, our fourth in the
U.S., continues to validate the strength of our intellectual property
for DUEXIS," said Timothy P. Walbert, chairman, president and chief
executive officer, Horizon Pharma. "Horizon will continue to
vigorously expand and protect the innovation and intellectual
property of DUEXIS, with protection currently out to 2028."
The Notice of Allowance concludes the substantive examination of this
U.S. patent application and will result in the issuance of the U.S.
patent after administrative processes are completed. The U.S. patent
scheduled to issue from this application will expire in 2028. After
issuance, Horizon plans to list the U.S. patent in the FDA's Approved
Drug Products with Therapeutic Equivalence Evaluations, or Orange
Book. Horizon has now been granted four patents covering DUEXIS in
the U.S. since October 2011.
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.
Important Safety Information About DUEXIS
DUEXIS is not right for
everyone. People who have had asthma,
hives, or an allergic reaction
to aspirin or other NSAIDs should not take DUEXIS. Women in the late
stages of pregnancy should not take DUEXIS. People who have had
allergic reactions to medications like famotidine (histamine
H2-receptor antagonists) should not take DUEXIS.
Tell your health care provider right away if you have signs of active
bleeding (persistent and unexplained) while you are taking DUEXIS.
NSAID-containing medications like DUEXIS can cause high blood
pressure or make existing high blood pressure worse, either of which
can increase the chance of a heart attack or stroke. Your health care
provider should check your blood pressure while you are taking
Before you start taking DUEXIS, tell your health care provider if you
have heart problems, kidney problems, or liver problems, or if you
are taking medications for high blood pressure. DUEXIS can increase
the chance of potentially significant liver injury and/or kidney
injury, which may be fatal. Stop taking DUEXIS immediately and
contact your health care provider if you experience any signs and/or
symptoms of liver or kidney injury.
Serious allergic reactions, including skin reactions, can happen
without warning and can be life threatening. Stop taking DUEXIS and
consult your doctor immediately if you get a skin rash or if you
start to have problems breathing or swallowing or if you develop
swelling of your face or throat.
The most common side effects of DUEXIS include nausea, diarrhea,
constipation, upper abdominal pain and headache.
Please see Medication Guide and full Prescribing Information,
available at 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, 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.
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 and the ability to protect the commercial
potential of DUEXIS to 2028. 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 DUEXIS, whether any patents 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.
Robert J. De Vaere
Executive Vice President, Chief Financial Officer
Burns McClellan, Inc.
Press spacebar to pause and continue. Press esc to stop.