Horizon Pharma plc
Dec 22, 2016

Horizon Pharma plc Announces the U.S. Patent and Trademark Office Issuance of an Additional Notice of Allowance With Claims Covering RAVICTI® (glycerol phenylbutyrate) Oral Liquid

Will Represent Seventh U.S. Patent to be Listed in the Orange Book for RAVICTI

DUBLIN, Ireland, Dec. 22, 2016 (GLOBE NEWSWIRE) -- 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 it has received a Notice of Allowance from the United States Patent and Trademark Office for U.S. patent application number 13/610,580, entitled "Methods of Therapeutic Monitoring of Phenylacetic Acid Prodrugs" that covers Horizon's U.S. approved medicine RAVICTI (glycerol phenylbutyrate) Oral Liquid.

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 on September 22, 2030.  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 RAVICTI®
RAVICTI is indicated for use as a nitrogen-binding agent for chronic management of adult and pediatric patients ≥2 years of age with urea cycle disorders (UCDs) who cannot be managed by dietary protein restriction and/or amino acid supplementation alone.  RAVICTI must be used with dietary protein restriction and, in some cases, dietary supplements (e.g., essential amino acids, arginine, citrulline and protein-free calorie supplements).  RAVICTI is indicated for use in all 28 Member States of the European Union and 3 Member States of the European Economic Area as a nitrogen-binding agent for chronic management of adult and pediatric patients two months of age and older with UCDs who cannot be managed by dietary protein restriction and/or amino acid supplementation alone.  RAVICTI is indicated for use in Canada as an adjunctive therapy for chronic management of adult and pediatric patients two years of age and older with UCDs. 

Important Safety Information

LIMITATIONS OF USE:

CONTRAINDICATIONS:

WARNINGS AND PRECAUTIONS:

ADVERSE REACTIONS:

DRUG INTERACTIONS:

About Urea Cycle Disorders (UCDs)
Urea Cycle Disorders or UCDs are inherited metabolic diseases caused by a deficiency of one of the enzymes or transporters that constitute the urea cycle.  The urea cycle involves a series of biochemical steps in which ammonia, a potent neurotoxin, is converted to urea, which is excreted in the urine.  UCD patients may experience episodes where they get symptoms from the ammonia in their blood being excessively high - called hyperammonemic crises - which may result in irreversible brain damage, coma or death.  UCD symptoms may first occur at any age depending on the severity of the disorder, with more severe defects presenting earlier in life.

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 11 medicines through its orphan, rheumatology and primary care business units.  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 issuance of a patent based on the Notice of Allowance from the U.S. Patent and Trademark Office, the expected term of the patent, if issued, potential patent protection for RAVICTI and plans to list newly issued patents in the FDA's Orange Book.  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 a 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 RAVICTI, whether any patents covering RAVICTI 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:

Tina Ventura

Senior Vice President, Investor Relations

investor-relations@horizonpharma.com



U.S. Media:

Geoff Curtis

Senior Vice President, Corporate Communications

media@horizonpharma.com



Ireland Media:

Ray Gordon

Gordon MRM

ray@gordonmrm.ie

Source: Horizon Pharma plc

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