諾華&創源 合作 canakinumab (Ilaris) 用藥基因檢測 (cryopyrin-associated periodic syndromes)

創源(4160)瞄準精準醫學商機，NGS孕產前基因檢測將獲國際NGS大廠認證 財訊新聞 2015/07/08 12:14【財訊快報／何美如報導】訊聯集團(1784)呼應台灣生技月「精準醫學」主軸，將於生技月展現成果，旗下創源生技(4160)伴隨式診斷協助的諾華藥廠，日前已通過健保給付審核，為台灣生技醫療產業落實精準醫學發展的一大代表，而年初建置的次世代定序(NGS)技術中心，預計月底將取得國際NGS大廠認證，成為台灣上市櫃生技公司第一家取得此認證之實驗室，未來更可提升國際檢測發展。訊聯生技集團董事長蔡政憲博士表示，針對用藥確認基因的「伴隨式診斷」，已是全球醫療產業發展的一大趨勢，它可結合診斷技術與醫療用藥，透過「以人施藥」的概念，協助病患達到精準治療，而此正是現今精準醫學強調的目的之一。創源生技投入伴隨式診斷多年，受諾華藥廠委託，於台灣進行終生性自體發炎週期性症候群(CAPS)患者對FDA通過用藥ILARIS的基因適應性，臨床證明符合施用ILARIS的病患的確可達到減緩發病的效益。諾華此藥日前剛通過衛福部健保給付審查，預計短期內適用此藥物治療的CAPS患者將可獲得健保給付。國際醫學近年正興起一個概念，讓精準醫學從胚胎及胎兒階段起始。大規模高通量定序與高敏感度檢測的次世代定序(NGS)，是讓精準醫學可快速發展的技術平台，是以斥資於今年初完成次世代定序(NGS)技術中心之建置，不但帶動訊聯生技的非侵入性胎兒染色體檢測服務(NIPT)收件數量翻倍成長，更推廣至非高齡、非高風險族群，讓NIPT成為精準醫學於孕產前發展的第一道篩檢工具，更是快速成為最具市場規模的精準醫學臨床應用。蔡政憲指出，訊聯生技集團預計第四季會朝向生殖醫學，將PGS技術升級為「次世代定序之胚胎著床前染色體晶片篩檢(NGS-based PGS)」，可篩檢出以往技術無法讀出的遺傳變異，能有效地提升胚胎植入率與懷孕率。旗下兩家公司訊聯生技與創源生技，雙雙藉由次世代定序技術平台，具體實現讓精準醫學從胚胎及胎兒階段起始的目標。隨著NGS技術中心建置完成，創源生技預計於月底將取得Illumina Certified Service Provider認證，成為台灣上市櫃生技公司第一家取得此認證之實驗室，不但代表確保NGS技術及檢測品質具備國際水準，未來不僅服務台灣孕產前基因檢測，還能提升國際檢測服務能量。

FDA Approves Ilaris for Rare Juvenile Arthritis  Robert Lowes Disclosures May 10, 2013 The US Food and Drug Administration (FDA) has approved canakinumab (Ilaris, Novartis) to treat active systemic juvenile idiopathic arthritis (JIA) in patients aged 2 years and older, the manufacturer announced today.  The drug, administered monthly by subcutaneous injection, is the first interleukin-1-beta inhibitor approved for this rare and disabling form of childhood arthritis, according to a press release from the manufacturer. Children with systemic JIA experience rapid onset of high daily fever, rash, high levels of inflammatory markers, and destructive arthritis. Some experts describe canakinumab as a more benign alternative to the corticosteroids often prescribed for systemic JIA. Impaired growth and osteoporosis are some of the adverse events associated with corticosteroids. Canakinumab is already approved to treat cryopyrin-associated periodic syndromes, including Familial Cold Autoinflammatory Syndrome and Muckle-Wells Syndrome. The drug's label warns that canakinumab may weaken the body's immune response to infections, increasing the risk for serious infection. Accordingly, clinicians should exercise caution when administering canakinumab to patients with infections, a history of recurring infections, or underlying conditions that may predispose them to infections. The FDA also advises that canakinumab should not be given concurrently with live vaccines. Last month, the FDA approved another anti-interleukin agent, tocilizumab (Actemra, Genentech), to treat polyarticular JIA in patients aged 2 years and older with active disease. Tocilizumab is an interleukin 6 receptor blocker. Tocilizumab was approved for systemic JIA in April 2011.