日本東麗(Toray) 抗搔癢藥(TRK-820, nalfurafine) 歐洲夥伴(Fresenius)/ 台灣夥伴(友華)

Toray Industries, Inc. Apr. 4, 2012 Toray and Fresenius Medical Care reach European license agreement on antipruritic TRK-820 Toray Industries, Inc. today announced the signing of an agreement with Fresenius Medical Care AG & Co. KGaA ("the company"; Frankfurt Stock Exchange: FME / New York Stock Exchange: FMS), the world's largest provider of dialysis products and services regarding exclusive development and marketing in Europe of an injectable form of TRK-820 (Toray development code; generic name: nalfurafine hydrochloride), an innovative antipruritic agent originated and developed by Toray. Under this agreement, Fresenius Medical Care will exclusively market the product in Europe once Toray receives approval for TRK-820 in the region. TRK-820 is a highly selective κ (kappa) opioid receptor agonist. It was launched in Japan in March 2009 as a treatment for hemodialysis-related uremic pruritus under the brand name REMITCH® CAPSULES 2.5μg (manufactured by and marketing approval held by Toray; distributed by Torii Pharmaceutical Co., Ltd.; in alliance with Japan Tobacco Inc.). In Europe, Toray has been developing the drug as an injection instead of the oral form, so that it can be administered at a dialysis center after receiving dialysis. Pruritus experienced by hemodialysis patients is non-inflammatory but generalized and severe although it is not so frequent. Some patients suffer from lack of sleep due to severe itching, which worsens their quality of life (QOL). In addition, scratching due to severe itching results in skin inflammation and infections which aggravate systemic symptoms. It is well known that conventional antipruritic agents including antihistamines cannot fully suppress this itching. Against this background, the injectable form of TRK-820 has been designated as an orphan drug by the European Medicines Agency (EMA) for treating pruritus experienced by hemodialysis patients. The agreement announced is a result of Toray's search for a strong sales network in the European dialysis-related pharmaceutical field. It also falls in line with Fresenius Medical Care's strategic objective to enhance its pharmaceutical product lineup for dialysis patients. The two companies will work together on preparing the Marketing Authorization Application for submission to the EMA this year, in order to obtain marketing approval and introduce the product to the market as soon as possible.

Fresenius Medical Care is the world's largest integrated provider of products and services for individuals undergoing dialysis because of chronic kidney failure, a condition that affects more than 2 million individuals worldwide. Through its network of 2,874 dialysis clinics in North America, Europe, Latin America, Asia-Pacific and Africa, Fresenius Medical Care provides dialysis treatment to 228,239 patients around the globe. Fresenius Medical Care is also the world's leading provider of dialysis products such as hemodialysis machines, dialyzers and related disposable products.

友華獲日本東麗台灣獨家授權 引進血液透析皮膚搔癢藥  鉅亨網記者胡薏文 台北2014-10-24  19:10生技業界台日合作再傳喜訊！友華生技(4120-TW)與日本東麗株式會社宣佈簽訂一項治療血液透析患者皮膚搔癢藥物TRK-820 合作協議，友華將取得由東麗所研發的TRK-820在台灣的獨家銷售權。TRK-820是一種新機轉致效劑，2009年3月起在日本上市，品名劑型為REMITCH CAPSULES 2.5 µg，專用於治療洗腎等血液透析患者常見的皮膚搔癢症。友華指出，TRK-820與現有的抗組織胺類止癢藥不同，此藥品係透過新機轉的調控以抑制皮膚搔癢，可望有效治療對現有抗組織胺藥物無效之搔癢，以改善血液透析患者的生活品質。血液透析患者常會有皮膚搔癢症，甚至非常嚴重，這些非發炎性(non-inflammatory)的搔癢症狀，與一般因組織胺引起搔癢的不太相同，甚至部分病患會因為嚴重搔癢影響睡眠，導致生活品質惡化。此外，搔癢會造成皮膚發炎和感染而加重全身症狀，傳統的止癢劑，例如抗組織胺，並無法完全抑制這種搔癢。台灣末期腎臟病的盛行率與發生率遠高於其它國家，對血液透析治療有高度需求，友華在腎臟疾病領域已經營許久，此次取得TRK-820獨家銷售權，將更擴大在此領域的發展範疇。未來透過臨床上的推廣運用，將為台灣的血液透析患者帶來新的治療方式，降低洗腎後皮膚搔癢之苦；東麗亦希望透過此次結盟能對台灣的洗腎病患有所貢獻。