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     546  0 Kommentare Horizon Pharma plc Receives Health Canada Approval for RAVICTI(R) (glycerol phenylbutyrate) Oral Liquid for the Treatment of Urea Cycle Disorders in Patients Two Years of Age and Older

    DUBLIN, IRELAND--(Marketwired - Mar 21, 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 that Health Canada has issued a Notice of Compliance (NOC) for RAVICTI® (glycerol phenylbutyrate) Oral Liquid for use as an adjunctive therapy for chronic management of adult and pediatric patients two years of age and older with Urea Cycle Disorders (UCDs).

    Last month Horizon announced that the Therapeutic Products Directorate of Health Canada had determined that RAVICTI® (Glycerol Phenylbutyrate) Oral Liquid is eligible for data protection as it is an "innovative drug" as defined by section C.08.004.1 of the Food and Drug Regulations. Based on the approval, RAVICTI will be added to the Register of Innovative Drugs and receive data protection for a term of up to eight years from the date of the issuance of the NOC.

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    UCDs, which impact approximately 200 people in Canada, 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.

    "The approval of RAVICTI in Canada is a significant milestone for Horizon Pharma as it continues to expand the accessibility of important medicines to patients with unmet treatment needs," said Timothy P. Walbert, chairman, president and chief executive officer, Horizon Pharma plc. "I commend Health Canada for acknowledging the importance of this innovative medicine and the company intends to rapidly pursue funding and reimbursement. Horizon will soon be filing clinical and cost effectiveness submissions to the respective health technology assessment agencies in Canada and engaging with public and private drug plans to ensure that patients with Urea Cycle Disorders who may benefit from treatment are able to access RAVICTI as quickly as possible."

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    Horizon Pharma plc Receives Health Canada Approval for RAVICTI(R) (glycerol phenylbutyrate) Oral Liquid for the Treatment of Urea Cycle Disorders in Patients Two Years of Age and Older DUBLIN, IRELAND--(Marketwired - Mar 21, 2016) - Horizon Pharma plc (NASDAQ: HZNP), a biopharmaceutical company focused on improving patients' lives by identifying, developing, acquiring and commercializing differentiated and accessible medicines …