FDA Confirms Paragraph IV Patent Litigation for Cysteamine Bitartrate
Enforcement Report - Week of October 21, 2020
Horizon Pharma`s Cysteamine Bitartrate Receives Approval in US
Italy’s Recordati said on Tuesday it plans to seek Canadian approval for its drug Cystagon, which treats a rare kidney disease, in a potential blow to Horizon Pharma,, which makes the only drug approved for treatment in Canada.
Canada’s Patented Medicine Prices Review Board (PMPRB) is actively investigating the price of Horizon Pharma’s Procysbi (cysteamine bitartrate), a treatment for an inherited medical condition called nephropathic cystinosis.
Horizon Pharma plc (NASDAQ:HZNP) (Horizon), 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 completed the sale of a European subsidiary that owns the marketing rights to PROCYSBI® (cysteamine bitartrate) delayed-release capsules and QUINSAIR™ (levofloxacin nebuliser solution) in Europe, the Middle East and Africa (EMEA) regions to Chiesi Farmaceutici S.p.A. (Chiesi) for an upfront payment of $72.2 million, with additional potential milestone payments based on sales targets.
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, and its affiliate Horizon Therapeutics Canada, today announced that Health Canada has issued a Notice of Compliance (NOC) for PROCYSBI™ (cysteamine delayed-release capsules) for the treatment of nephropathic cystinosis in adults and children 2 years of age and older.
Horizon Pharma plc Announces Agreement to Sell European Marketing Rights to PROCYSBI