Horizon Pharma Announces Settlement of DUEXIS(R) Patent Litigation With Par Pharmaceutical
August 22 2013 - 7:30AM
Marketwired
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® (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 covering DUEXIS.
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
famotidine) tablets.
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."
About 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.
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 DUEXIS.
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.
Forward-Looking Statements
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.
Contacts Robert J. De Vaere Executive Vice President and
Chief Financial Officer Email Contact Investors Kathy Galante Burns
McClellan, Inc. 212-213-0006 Email Contact
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