Horizon Pharma Announces Settlement of DUEXIS(R) Patent Litigation With Par
DEERFIELD, IL -- (Marketwired) -- 08/22/13 -- Horizon Pharma, Inc.
(NASDAQ: HZNP) today announced that it has entered into settlement
and license agreements with Par Pharmaceutical Companies, Inc. and
its subsidiary Par Pharmaceutical, Inc., to resolve pending patent
litigation involving DUEXIS(R) (ibuprofen and famotidine) tablets.
Under the license agreement, Horizon has granted Par the
non-exclusive right to market a generic ibuprofen and famotidine
product in the U.S. under Par's Abbreviated New Drug Application
(ANDA), beginning January 1, 2023, or earlier under certain
circumstances. Currently, Horizon has listed six Orange Book patents
The settlement agreement includes a stipulation by the parties
requesting dismissal without prejudice of the lawsuit filed by
Horizon in the U.S. District Court for the District of Delaware
relating to the ANDA filed by Par with the U.S. Food and Drug
Administration for a generic version of DUEXIS (ibuprofen and
Details of the settlement are confidential, and the agreements are
subject to submission to the Federal Trade Commission and the U.S.
Department of Justice. The settlement and license agreements will
become effective upon the entry by the U.S. District Court for the
District of Delaware of an order dismissing without prejudice the
litigation with respect to Par.
"We believe this settlement validates the innovation and breadth of
the DUEXIS patent portfolio," said Timothy P. Walbert, chairman,
president and chief executive officer, Horizon Pharma. "DUEXIS offers
important potential advantages to patients suffering from
osteoarthritis who are at risk of developing upper gastrointestinal
ulcers and we look forward to many years of continued growth."
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, 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 strategy 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 the anticipated results or benefits of the
settlement and license agreements with Par, the entry by the U.S.
District Court for the District of Delaware of an order dismissing
the litigation with respect to Par's ANDA filing, and anticipated
growth of DUEXIS sales. 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 whether
the U.S. Federal Trade Commission or Department of Justice challenge
the enforceability of or seek to enjoin the entry into the settlement
and license agreements, whether the U.S. District Court will grant an
order dismissing the litigation, whether additional third parties may
seek to market generic versions of DUEXIS by filing ANDAs with the
FDA and the results of any litigation that Horizon files to defend
and/or assert its patents against such third parties, the occurrence
of events under the license agreement that would allow Par to market
its generic version of DUEXIS earlier than anticipated, Horizon's
ability to commercialize products successfully, the impact of pricing
decisions on product revenues, Horizon's ability to successfully
manage contract sales and marketing personnel, Horizon's ability to
comply with post-approval regulatory requirements and the need to
potentially obtain additional financing to successfully commercialize
or further develop DUEXIS. 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.
Robert J. De Vaere
Executive Vice President and Chief Financial Officer
Burns McClellan, Inc.
Press spacebar to pause and continue. Press esc to stop.