Horizon Pharma plc Announces District Court Decision to Uphold PENNSAID® (diclofenac sodium topical solution) 2% w/w Patent
May 15 2017 - 7:00AM
Horizon Pharma plc (NASDAQ:HZNP), a biopharmaceutical company
focused on improving patients’ lives by identifying, developing,
acquiring and commercializing differentiated and accessible
medicines that address unmet medical needs, today announced that
the United States District Court for the District of New Jersey
upheld the validity of Horizon Pharma’s patent covering PENNSAID®
(diclofenac sodium topical solution) 2% w/w, which Actavis
Laboratories UT, Inc. (Actavis) has admitted that its proposed
generic diclofenac sodium topical solution product would infringe.
On July 6, 2015, Horizon filed a patent infringement lawsuit in
District Court against Actavis related to Abbreviated New
Drug Applications filed with the U.S. Food and Drug
Administration to market a generic version of PENNSAID 2%.
The lawsuit claims infringement of Horizon's U.S. Patent No.
9,066,913 (‘913 patent) titled "Diclofenac Topical Formulation,"
which covers PENNSAID 2%. The District Court’s decision was
made based on the validity of Horizon Pharma’s ‘913 patent for
PENNSAID 2% and the Court’s judgment will prevent Actavis from
launching a generic version of PENNSAID 2% in the United
States.
PENNSAID 2% has 18 Orange Book listed patents with terms that
extend to 2030.
About PENNSAID 2% PENNSAID (diclofenac sodium
topical solution) 2% w/w is a non-steroidal anti-inflammatory drug
(NSAID) indicated for the treatment of pain of osteoarthritis (OA)
of the knee(s). PENNSAID 2% contains diclofenac sodium, an
NSAID, and also includes dimethyl sulfoxide (DMSO), a powerful
penetrating agent that helps ensure that diclofenac sodium is
absorbed through the skin to the site of inflammation and
pain. PENNSAID 2% is an alternative to oral NSAID treatment,
reducing systemic exposure to a fraction of that provided by the
oral NSAID diclofenac. The only topical NSAID offered with
the convenience of a metered-dose pump, PENNSAID 2% is applied in
two pumps, twice daily, to the site of OA knee pain. For more
information, please see www.PENNSAID.com.
IMPORTANT SAFETY INFORMATION
WARNING: CARDIOVASCULAR AND GASTROINTESTINAL
RISK
Heart Risk
- Non-steroidal anti-inflammatory drugs (NSAIDs) may
cause an increased risk of serious heart clotting events, heart
attack and stroke, which can kill you. This risk may increase
with longer use. Patients with heart disease or risk factors
for heart disease may be at greater risk.
- PENNSAID 2% should not be used if you are in the
hospital for certain heart surgeries.
Stomach and Intestine Risk
- NSAIDs cause an increased risk of serious stomach and
intestine events including bleeding, ulcers and holes in the
stomach or intestines, which can kill you. These events can
occur at any time during use and without warning symptoms.
Elderly patients are at greater risk for serious stomach and
intestine events.
CONTRAINDICATIONS
- DO NOT USE PENNSAID 2% if you:• are in the hospital for
certain heart surgeries.• know you are allergic to diclofenac
sodium or any other ingredient of PENNSAID 2%.• have
experienced asthma, hives, or allergic-type reactions after taking
aspirin or other NSAIDs. Severe, allergic reactions that will
rarely kill you, to NSAIDs have been reported in such
patients.
WARNINGS AND PRECAUTIONS
- To minimize the potential for increased risk of serious heart
events while being treated with an NSAID, use the lowest effective
dose for the shortest duration possible.
- Elevation of one or more liver tests may occur during therapy
with NSAIDs. PENNSAID 2% should be discontinued immediately
if abnormal liver tests persist or worsen.
- Use with caution in patients with fluid retention or heart
failure.
- Hypertension can occur with NSAID treatment. Monitor
blood pressure closely with PENNSAID 2% treatment.
- Long-term use of NSAIDs can result in severe kidney
injury. Use PENNSAID 2% with caution in patients at greatest
risk of this reaction, including the elderly, those with impaired
kidney function, heart failure, liver dysfunction and those taking
diuretics and ACE-inhibitors (certain blood pressure
medicines).
- Severe allergic reactions may occur without prior use of
PENNSAID 2%. NSAIDs can cause serious skin reactions such as
exfoliative dermatitis, Stevens-Johnson Syndrome (SJS) and toxic
epidermal necrolysis (TEN), which can kill you.
- Wash and dry hands before and after use. Avoid contact of
PENNSAID 2% with the eyes, nose and mouth.
- PENNSAID 2% was not studied under the conditions of heat
application, complete covering bandages or exercise; therefore,
concurrent use of PENNSAID under these conditions is not
recommended.
- Do not:• Apply PENNSAID 2% to open wounds.• Shower
for at least 30 minutes after applying PENNSAID 2%.• Wear
clothing over the PENNSAID 2% treated knee until the treated knee
is dry.
- Protect treated knee(s) from natural or artificial
sunlight.
- Protect treated knee(s) from sunlight (real and tanning
booths).
- Topicals, such as sunscreen and bug repellent, should not be
used until after PENNSAID 2% treated knee(s) are completely
dry.
- Do not use with oral NSAIDs unless your doctor says it is OK
and you have lab tests to check your progress.
- There is no consistent evidence that regular use of aspirin
lessens the increased risk of serious heart events, such as heart
clotting, heart attack and stroke associated with NSAID use.
As with all NSAIDs, regular administration of PENNSAID 2% and
aspirin is not generally recommended because of the potential of
increased risks.
ADVERSE REACTIONS
- The most common adverse events in a phase 2 clinical trial of
PENNSAID 2% were application site reactions, such as dryness (22%),
peeling (7%), redness (4%), itching (2%), pain (2%), skin hardening
(2%), rash (2%) and scabbing ( < 1%). Other adverse
reactions occurring in > 1% of patients receiving PENNSAID 2%
included bladder infection (3%), bruising (2%), sinus congestion
(2%) and nausea (2%).
USE IN SPECIFIC POPULATIONS
- PENNSAID 2% should not be used in pregnant women or in women
who are breastfeeding and is not approved for use in children.
For more information on PENNSAID 2%, please see the Medication
Guide and Full Prescribing Information, available at
www.PENNSAID.com.
About Horizon Pharma plcHorizon Pharma plc is a
biopharmaceutical company focused on improving patients' lives by
identifying, developing, acquiring and commercializing
differentiated and accessible medicines that address unmet medical
needs. The Company markets 11 medicines through its orphan,
rheumatology and primary care business units. For more
information, please visit www.horizonpharma.com.
Follow @HZNPplc on Twitter or view careers on
our LinkedIn page.
Forward-Looking Statements This press release
contains forward-looking statements, including statements regarding
the impact of the District Court’s ruling on Horizon Pharma’s ‘913
patent. These forward-looking statements are based on
management 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
Actavis appeals the District Court’s decision and whether the
decision is upheld on such an appeal and other factors described in
Horizon Pharma'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 Pharma does not undertake any obligation to update or
revise these statements, except as may be required by law.
Contacts:
Tina Ventura
Senior Vice President, Investor Relations
Investor-relations@horizonpharma.com
Ruth Venning
Executive Director, Investor Relations
Investor-relations@horizonpharma.com
U.S. Media Contacts:
Geoff Curtis
Senior Vice President, Corporate Affairs & Chief Communications Officer
media@horizonpharma.com
Ireland Media Contact:
Ray Gordon
Gordon MRM
ray@gordonmrm.ie
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