Horizon Pharma plc Announces Settlement of PENNSAID(R) (diclofenac sodium topical solution) 2% w/w Patent Litigation With Teligent, Inc.

DUBLIN, IRELAND–(Marketwired – May 12, 2016) – 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 its affiliates have entered into a settlement and license agreement with Teligent, Inc. to resolve pending patent litigation involving PENNSAID® (diclofenac sodium topical solution) 2% w/w (PENNSAID® 2%).

Under the settlement and license agreement, Horizon has granted Teligent the non-exclusive right to market a generic diclofenac sodium topical 2% w/w solution in the United States under Teligent’s Abbreviated New Drug Application (ANDA) beginning January 10, 2029 or earlier under certain circumstances.

The agreement follows the May 2, 2016, entry of a stipulation of dismissal without prejudice of all lawsuits filed by Horizon in the U.S. District Court for the District of New Jersey relating to the ANDA filed by Teligent with the U.S. Food and Drug Administration for a generic version of PENNSAID 2%.

Details of the settlement are confidential and the agreement is subject to submission to the Federal Trade Commission and the U.S. Department of Justice.

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 woman 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 plc
Horizon 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 nine medicines through its orphan, rheumatology and primary care business units. Horizon’s global headquarters are in Dublin, Ireland. 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 anticipated results of or future actions of the parties under the settlement and license agreement for PENNSAID 2%. 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, but are not limited to, risks regarding whether the U.S. Federal Trade Commission or Department of Justice will challenge the enforceability of or seek to enjoin the entry into the settlement and license agreement, whether the U.S. District Court will grant an order dismissing the litigation, whether additional third parties may seek to market generic versions of PENNSAID 2% by filing ANDAs with the FDA and the results of any litigation that Horizon files to defend or assert its patents against such third parties, the occurrence of events under the settlement and license agreement that would allow Teligent to market its generic version of PENNSAID 2% earlier than anticipated, and other 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 does not undertake any obligation to update or revise these statements, except as may be required by law.