DUBLIN, IRELAND--(Marketwired - May 11, 2016) - Horizon Pharma plc (
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
CONTRAINDICATIONS
WARNINGS AND PRECAUTIONS
ADVERSE REACTIONS
The most commonly reported serious adverse reactions in the pivotal trial with the approved regimen of 8 mg KRYSTEXXA administered every 2 weeks were gout flares, infusion reactions, and anaphylaxis. Most common adverse reactions: gout flares (77%), infusion reactions (26%), nausea (12%), contusion or ecchymosis (11%), nasopharyngitis (7%), constipation (6%), chest pain (6%), anaphylaxis (5%), and vomiting (5%). In addition to events occurring in greater than 5%, exacerbation of pre-existing congestive heart failure occurred in 2%.
Please see the Medication Guide and Prescribing Information, including Boxed Warning, located at www.krystexxa.com for more information.
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 potential issuance of a patent based on the Notice of Allowance from the U.S. Patent and Trademark Office, the expected terms of the patent, if issued, and potential patent protection for KRYSTEXXA. 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 the administrative processes required for the issuance of the patent as indicated in the Notice of Allowance will be completed in a timely matter or at all, whether the patent, if issued as indicated in the Notice of Allowance, will provide sufficient protection and market exclusivity for KRYSTEXXA, whether any patent covering KRYSTEXXA may be challenged, invalidated, infringed or circumvented by third parties and other 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.
Contacts:
Investors:
John Thomas
Executive Vice President, Strategy and Investor Relations
[email protected]
Tina Ventura
Vice President, Investor Relations
[email protected]
U.S. Media:
Geoff Curtis
Senior Vice President, Corporate Communications
[email protected]
Ireland Media:
Ray Gordon
Gordon MRM
[email protected]
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