2014年12月3日讯 /生物谷BIOON/ --近日，强生出于自身免疫管线的深度分析及前景考虑，宣布退出与安斯泰来关于类风湿性关节炎（RA）药物ASP015K高达9.45亿美元的合作。此举将使安斯泰来独自承担所有项目，并使该药的前景陷入危险之中。
根据2012年达成的协议，强生支付6500万美元预付款及其他承诺，获得ASP015K在日本以外的权利。ASP015K是一种口服JAK抑制剂，旨在阻断炎症信号治疗免疫疾病（如RA）的根本病因。现在，强生选择了退出，并同意将ASP015K权利全部归还给安斯泰来，同时将停止相关III期临床试验。
安斯泰来表示，计划继续保留ASP015K的日本项目，目前该项目已进入III期临床。同时，该公司正在考虑ASP015K在日本以外地区的未来前景。
去年，ASP015K完成了2项IIb期研究，调查作为每日一次的类风湿性关节炎（RA）口服药物。在声明中，强生表示，退出合作开发ASP015K的决定，是基于对自身免疫管线的深度分析及所观察到的令人激动的未来前景所制定的战略性投资组合决策的结果。
强生此举，将使安斯泰来独自承担开发口服JAK抑制剂用于炎症性疾病。在该领域中，安斯泰来将面临激烈竞争，礼来（Eli Lilly）和Incyte的口服药物baricitinib已处于III期临床，而辉瑞(Pfizer)的口服药物Xeljanz已于2012年上市。这些巨头都迫切希望能在TNF阻断剂类重磅药物统治的市场中占得一席之地。目前，该市场由艾伯维（AbbVie）的Humira（阿达木单抗）、安进（Amgen）的恩利（Enbrel）、强生（JNJ）的Remicade统治。这些药物都是年销售额达数十亿美元的重磅生物制剂，但每一种药物都即将面临专利到期，这意味着，口服JAK抑制剂开发商在努力攻占市场的同时，将很快面临廉价生物仿制药的激烈竞争。
英文原文：J&J scuttles a $945M arthritis deal with Astellas on the eve of Phase III
Johnson & Johnson ($JNJ) is walking away from a potential rheumatoid arthritis treatment from Astellas, nixing a deal that could have paid out at $945 million and putting the drug's stateside future in jeopardy.
Under a 2012 agreement, J&J paid $65 million up front and promised loads more to acquire the ex-Japan rights to ASP015K, an oral JAK inhibitor designed to block inflammatory signaling and treat the underlying cause of immune diseases like RA. Now the U.S. pharma giant has exercised its opt-out clause, agreeing to hand back full rights on Jan. 15 and stopping short of running Phase III trials on the RA drug.
Astellas said it plans to stay the course on ASP015K's Japanese program, now entering late-stage studies, and the company is "considering the future plan" for the drug outside its home country.
Last year, ASP015K completed two Phase IIb studies testing its effect as a once-a-day treatment for RA, and ClinicalTrials.gov lists at least one J&J-sponsored study of the drug as actively enrolling. In a statement, J&J said its decision to ditch the JAK inhibitor "is the result of a strategic portfolio decision" made in light of "the depth of our immunology pipeline and the exciting opportunities we see ahead."
That leaves Astellas to go it alone in the world of oral JAK inhibitors for inflammatory disease, contending with the Phase III baricitinib, from Incyte ($INCY) and Eli Lilly ($LLY), and Pfizer's ($PFE) Xeljanz, a drug that has failed to catch on as quickly as analysts expected when it won approval in 2012.
Each hopes to take some market share from the TNF-blocking injectable blockbusters that have long dominated the inflammatory space, led by AbbVie's ($ABBV) Humira, Amgen's ($AMGN) Enbrel and J&J's own Remicade. Such therapies account for tens of billions of dollars in sales every year, but each is nearing patent expiration, meaning the developers of oral alternatives will soon have to compete with cheaper biosimilars as they work to crack the market.