开展治疗高磷酸盐血症的III期临床试验

　Keryx生物制药有限公司（Nasdaq：KERX）4月18日宣布，其日本合作伙伴日本烟草产业株式会社（Japan Tobacco Inc.，JT）及其医药经营子公司Torii制药公司（Torii Pharmaceutical，Torii）已经在日本开展了用柠檬酸铁治疗高磷酸盐血症患者的III期临床试验。根据与JT/Torii的授权协议，Keryx公司将在30天内收到JT/Torii为此里程碑成果支付的概不退还的500万美元里程碑款项。

Zerenex™（柠檬酸铁）是一种三价铁磷酸盐结合剂，用于治疗终末期肾脏疾病患者在透析治疗时的高磷酸盐血症（磷酸盐水平升高），它在美国已进入III期临床开发阶段。

　 Keryx公司的首席执行官Ron Bentsur称，他们祝贺其伙伴JT/Torii在日本启动了该药的III期临床试验并为此进展感到高兴。他们相信这足以进一步验证Zerenex的全球商业潜力。

　 Keryx公司从宝龄富锦生技股份有限公司（Panion & BF Biotech, Inc.）获得了对Zerenex除了某些亚太国家之外的全球许可，之后该公司将此药再授权给日本烟草产业株式会社及Torii制药公司。

　在2007年9月，Keryx公司将其治疗高磷酸盐血症的药物Zerenex（柠檬酸铁）在日本的开发和经营权独家授权给JT和Torii公司。此次授权协议要求JT和Torii公司支付给Keryx公司多达1亿美元的前期许可费以及因其里程碑成果而获得的报酬，截至发稿前Keryx已经收到了其中的2800万美元。此外，在药物开始销售后，JT和Torii公司将根据其在日本销售的销售净值给Keryx公司支付特许使用费。JT和Torii公司将承担在日本的所有技术开发和营销的成本。

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Keryx Biopharmaceuticals is focused on the acquisition, development and commercialization of medically important pharmaceutical products for the treatment of life-threatening diseases, including cancer and renal disease. Keryx is developing KRX-0401 (perifosine), a novel, potentially first-in-class, oral anti-cancer agent that inhibits Akt activation in the phosphoinositide 3-kinase (PI3K) pathway, and also affects a number of other key signal transduction pathways, including the JNK pathway, all of which are pathways associated with programmed cell death, cell growth, cell differentiation and cell survival. KRX-0401 has demonstrated both safety and clinical efficacy in several tumor types, both as a single agent and in combination with novel therapies. KRX-0401 is currently in Phase 3 clinical development for both refractory advanced colorectal cancer and multiple myeloma 结肠直肠癌和多发性骨髓瘤, and in Phase 1 and 2 clinical development for several other tumor types. Each of the KRX-0401 Phase 3 programs are being conducted under Special Protocol Assessment (SPA) agreements with the FDA. Keryx is also developing Zerenex^TM (ferric citrate), an oral, iron-based compound that has the capacity to bind to phosphate and form non-absorbable complexes. The Phase 3 clinical program of Zerenex^TM in the treatment for hyperphosphatemia (elevated phosphate levels) in patients with end-stage renal disease is being conducted pursuant to an SPA agreement with the FDA. 一种三价铁磷酸盐结合剂，用于治疗终末期肾脏疾病患者在透析治疗时的高磷酸盐血症（磷酸盐水平升高）