Horizon Pharma plc Announces the U.S. Patent and Trademark Office Issuance of an Additional Notice of Allowance With Claims Covering PENNSAID(R) 2%

DUBLIN, IRELAND--(Marketwired - Dec 1, 2015) - 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 it received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for U.S. patent application number 14/804,720 (U.S. publication number 2015-0320708), entitled "Treatment of Pain with Topical Diclofenac" that covers Horizon's U.S. approved medicine PENNSAID® (diclofenac sodium topical solution) 2% w/w (PENNSAID 2%).

This Notice of Allowance concludes the substantive examination of the patent application and will result in the issuance of a U.S. patent after administrative processes are completed. The U.S. patent scheduled to issue from this application will expire October 17, 2027. After issuance, Horizon plans to list the U.S. patent in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations, or Orange Book.

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