SOURCE: Horizon Pharma plc

Horizon Pharma plc

October 21, 2015 07:00 ET

Horizon Pharma plc Announces Favorable Markman Ruling in RAVICTI® (glycerol phenylbutyrate) Oral Liquid Patent Infringement Lawsuit

DUBLIN, IRELAND--(Marketwired - Oct 21, 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 that a favorable Markman ruling has been issued by Judge Roy Payne in the United States District Court for the Eastern District of Texas Marshall Division in the patent infringement lawsuit filed by Horizon against Par Pharmaceutical, Inc. for an Abbreviated New Drug Application ("ANDA") to market a generic version of RAVICTI.

A Markman ruling, also known as a Claim Construction Ruling, is a determination by the court of the meaning and scope of disputed patent claim terms of certain patents in suit. Judge Payne was asked to construe disputed claim terms in U.S. Patent No. 8,404,215 ("the '215 patent") and U.S. Patent No. 8,642,012 ("the '012 patent") and adopted Horizon's proposed construction of all but one of the disputed claim terms. 

"We are pleased with the Court's ruling and are confident in the strength of the RAVICTI patent estate," said Timothy P. Walbert, chairman, president and chief executive officer, Horizon Pharma plc. 

About RAVICTI
RAVICTI is approved in the United States as a nitrogen-binding agent for chronic management of adult and pediatric patients greater or equal to two 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). The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion on September 25, 2015 for RAVICTI for use as an adjunctive therapy for chronic management of adult and pediatric patients greater than two months of age with UCDs.

Important Safety Information

LIMITATIONS OF USE:

  • RAVICTI is not indicated for the treatment of acute hyperammonemia in patients with UCDs because more rapidly acting interventions are essential to reduce plasma ammonia levels
  • The safety and efficacy of RAVICTI for the treatment of N-acetylglutamate synthase (NAGS) deficiency has not been established
  • The use of RAVICTI in patients < 2 months of age is contraindicated

CONTRAINDICATIONS:

  • In patients less than 2 months of age
  • In patients who develop or have known hypersensitivity to phenylbutyrate

WARNINGS AND PRECAUTIONS:

  • Phenylacetate (PAA), the major metabolite of RAVICTI, may be toxic at levels ≥ 500 µg/mL. Reduce RAVICTI dosage if symptoms of neurotoxicity, including vomiting, nausea, headache, somnolence, confusion, or sleepiness are present in the absence of high ammonia or other intercurrent illnesses.
  • Low or absent pancreatic enzymes or intestinal disease resulting in fat malabsorption may result in reduced or absent digestion of RAVICTI and/or absorption of phenylbutyrate and reduced control of plasma ammonia. Monitor ammonia levels closely.
  • RAVICTI should be used with caution in patients who are pregnant or planning to become pregnant. Based on animal data it may cause fetal harm. A voluntary patient registry will include evaluation of pregnancy outcomes in patients with UCDs. For more information regarding the registry program, visit www.ucdregistry.com or call 1-855-823-2592.
  • Caution should be exercised when administering RAVICTI to nursing mothers, as breastfeeding is not recommended with maternal use of RAVICTI. It is not known whether RAVICTI or its metabolites are present in breast milk.

ADVERSE REACTIONS:

  • Adverse reactions occurring in ≥ 10% of adult patients during short-term treatment (n=44, 4 weeks) with RAVICTI were diarrhea, flatulence and headache.
  • Adverse reactions occurring in ≥ 10% of adult patients during long-term treatment (n=51, 12 months) with RAVICTI were nausea, vomiting, diarrhea, decreased appetite, hyperammonemia, dizziness, headache and fatigue.
  • Adverse events occurring in ≥ 10% of pediatric patients during long-term treatment (n=26, 12 months) with RAVICTI were upper abdominal pain, rash, nausea, vomiting, diarrhea, decreased appetite, hyperammonemia and headache.

DRUG INTERACTIONS:

  • Corticosteroids, valproic acid or haloperidol: May increase plasma ammonia level. Monitor ammonia levels closely
  • Probenecid: May affect renal excretion of metabolites of RAVICTI, including PAGN and PAA

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 seven medicines through its orphan, primary care and specialty 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.

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