Horizon Pharma plc Announces Settlement of PENNSAID(R) (diclofenac sodium topical solution) 2% w/w Patent Litigation With Amneal Pharmaceuticals LLC

DUBLIN, IRELAND--(Marketwired - Apr 25, 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 Amneal Pharmaceuticals LLC 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 Amneal the non-exclusive right to market a generic diclofenac sodium topical 2% w/w solution in the United States under Amneal's Abbreviated New Drug Application (ANDA), beginning January 10, 2029 or earlier under certain circumstances.

The 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 New Jersey relating to the ANDA filed by Amneal 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.