Horizon Pharma plc Announces the U.S. Patent and Trademark Office Issuance of Additional Notice of Allowance With Claims Covering KRYSTEXXA(R) (pegloticase)

DUBLIN, IRELAND--(Marketwired - May 11, 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 it received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for U.S. patent application number 13/379,704 (U.S. publication number 2012-0301454), entitled "Methods and Kits for Predicting Infusion Reaction Risk and Antibody-Mediated Loss of Response by Monitoring Serum Uric Acid During Pegylated Uricase Therapy" that covers Horizon's U.S. approved medicine KRYSTEXXA® (pegloticase).

The 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 June 25, 2030.

About KRYSTEXXA
KRYSTEXXA (pegloticase) is a PEGylated uric acid specific enzyme and the first and only FDA-approved medicine indicated for the treatment of chronic gout in adult patients refractory to conventional therapy, which occurs when uric acid build up in the blood remains high and inflammation persists even after treatment with conventional therapies. According to estimates, chronic refractory gout impacts approximately 50,000 people in the United States. For more information, please see www.KRYSTEXXA.com.

IMPORTANT SAFETY INFORMATION

Important Limitations of Use:
KRYSTEXXA is not recommended for the treatment of asymptomatic hyperuricemia.

WARNING: ANAPHYLAXIS AND INFUSION REACTIONS

• Anaphylaxis and infusion reactions have been reported to occur during and after administration of KRYSTEXXA.
• Anaphylaxis may occur with any infusion, including a first infusion, and generally manifests within 2 hours of the infusion.
• However, delayed-type hypersensitivity reactions have also been reported.
• KRYSTEXXA should be administered in healthcare settings and by healthcare providers prepared to manage anaphylaxis and infusion reactions.
• Patients should be premedicated with antihistamines and corticosteroids.
• Patients should be closely monitored for an appropriate period of time for anaphylaxis after administration of KRYSTEXXA.
• Monitor serum uric acid levels prior to infusions and consider discontinuing treatment if levels increase to above 6 mg/dL, particularly when 2 consecutive levels above 6 mg/dL are observed.

CONTRAINDICATIONS