英文药名: Zebinix(Eslicarbazepine Acetate Tablets)

中文药名: 醋酸艾利西平片

生产厂家: Eisai Inc.

药品介绍

卫材欧洲公司近日表示从Bial-Portela公司获得了抗癫痫药Zebinix（eslicarbazepine，醋酸艾司利卡西平）在欧洲的销售权。Zebinix为一种新型的抗癫痫药，目前正由Bial公司开发，被认为是通过调节钠通道活动来产生治疗作用。
试验显示Zebinix一天一次不仅显著降低难控性癫痫部分性发作患者的发作频率，还可提高患者生活质量降低抑郁症状。Bial公司于2008年3月在欧洲递交了该药的上市申请，预防在2009年第一季度可获得批准作为辅助疗法用于治疗成人癫痫部分性发作。在欧洲约有340万人受癫痫影响。

Zebinix在德国和澳大利亚上市
Zebinix（eslicarbazepine acetate）是一种电压门控性钠通道阻滞剂，现已在德国上市。该药可作为癫痫部分发作成年患者（无论是否继发全身性发作）的辅助治疗。德国出售的药品规格为800mg片剂。本品也已经在澳大利亚上市（Eisai公司消息）。

卫材与Bial就癫痫药Zebinix欧洲销售达成协议
卫材与Bial就癫痫药Zebinix(eslicarbazepine acetate)在欧洲的销售权达成协议，Bial已向卫材支付9500万欧元预付金，这是该公司处于晚期研发阶段的第二种癫痫药，表明其致力于拓展其癫痫药市场的决心。
Zebinix在欧洲的销售申请于2008年3月份提交，Bial公司希望这份申请能在今年第二季度通过批准，使该药能尽快在当地上市销售，作为辅助药物用于那些部分发作性、伴有或不伴有继发性全身发作症状的18岁以上癫痫症患者。
Zebinix的安全性和疗效已在三项随机双盲安慰剂对照III期临床实验中得到证实，参加这一系列实验的受试者人数达1049人，他们均为部分发作性癫痫症患者。实验结果显示，这种药物可以显著减少患者发病次数，缓解抑郁症状，明显提高患者的生活质量，且疗效稳定。
卫材已推出多种癫痫药，其中包括通用名药Zonegran(zonisamide)、最近刚推出的Banzel/Inovelon (rufinamide)和正处在III期临床阶段的perampanel (E2007)。该公司善于利用药物许可权交易扩大其在神经病治疗药领域的存在。

临床结果显示抗痫药Zebinix显著降低发病频率
一项延展性III期临床实验结果显示，Zebinix(eslicarbazepine acetate)作为辅助药物治疗癫痫症患者后，他们的发病频率显著降低，并且疗效能长期保持。
实验数据显示，那些未使用过现有抗痫药物治疗的患者以Zebinix作为辅助药物治疗之后，他们的发病频率平均降低了61%，该药仅需每日使用一次。
此外，该药的安全性和疗效均在实验中得到了证实，它的面世为癫痫症患者提供了一种全新有效的治疗选择。

规格：800mg *30 片

Zebinix (TM), a New Antiepileptic Drug, Related to Tegretol, is Recommended for Approval in Europe
Eslicarbazepine, brand name Zebinix™, is a new epilepsy drug, related to carbamazepine (Tegretol™) and oxcarbazepine (Trileptal™). Discovered in 1996, it may have fewer drug interactions than do carbamazepine and oxcarbazepine. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA, the European equivalent of the FDA) has just recommended marketing approval of Zebinix for add-on therapy in adults with partial-onset seizures, with or without secondary generalization. Among people whose seizures previously were uncontrolled, seizures were reduced in clinical trials on average by more than a third. Side effects in the trials seemed relatively minimal. The drug was developed by Bial-Portela & Ca, S.A., a Portuguese pharmaceutical company. Two other companies, Sepracor, Inc. and Eisai, will cooperate in commercialization of Zebinix™ in various parts of the world.

Novel Anti-epileptic ZEBINIX® Approved In The European Union - New Option For Treatment Of Patients With Partial-Onset Seizures
Eisai Europe Limited (Headquarters: Hatfield, UK, Chairman & CEO: Yutaka Tsuchiya, "Eisai Europe"), the European subsidiary of Eisai Co., Ltd. (Headquarters: Tokyo, President & CEO: Haruo Naito), and Bial - Portela & Ca, S.A. (Headquarters: São Mamede do Coronado, Portugal, CEO: Luís Portela, "Bial") announced today that the anti-epileptic drug, Zebinix® (eslicarbazepine acetate), for which Eisai Europe obtained rights from Bial to market in Europe, was approved by the European Commission on April 21st, as an adjunctive therapy in adult patients with partial-onset seizures, with or without secondary generalisation.

Zebinix® is a novel once daily anti-epileptic drug developed by Bial and it is believed to exert an antiepileptic effect by regulating the activity of sodium channels. The efficacy and safety of Zebinix® when used in combination with other anti-epileptic drugs have been shown in clinical data from three Phase III studies (multi-centre, randomized, double-blind, placebo-controlled trials) conducted in 23 countries with more than 1,000 patients with refractory partial-onset seizures. Zebinix® demonstrated significant reductions in seizure frequency and a significant increase in responder rates (≥ 50% reduction in seizure frequency) across all three Phase III studies. In addition, Zebinix® showed a sustained decrease in seizure frequency and a significant improvement in quality of life during the long-term (one-year) open label studies conducted subsequent to those Phase III studies.

Epilepsy has a high preva lence among central nervous system diseases and affects about 3.4 million people in Europe. There are many patients with epilepsy whose condition is difficult to treat with existing anti-epileptic drugs for seizure control. The impact of seizures on patients' quality of life should not be underestimated.

With the approval of Zebinix®, Eisai Europe will launch Zebinix® during FY2009 and FY2010 across Europe, under the terms of a license and co-promotion agreement signed with Bial on February 19th this year.

Eisai has been selling two other anti-epileptic drugs, Zonegran® for partial-onset seizures and Inovelon® for Lennox-Gastaut Syndrome, in Europe. Eisai will bring Zebinix®, a new treatment option, to patients with epilepsy as early as possible and make further contributions to addressing the diversified needs and improving quality of life of patients with epilepsy.

About Bial - Portela & Ca, S.A.
Founded in 1924, Bial is an international pharmaceutical group with products available in over 30 countries throughout four continents. Bial is the largest Portuguese pharmaceutical company and is based in S. Mamede do Coronado, Portugal.

It is the partner of choice for many companies, having a strong presence in the Iberian peninsula as well as in over 10 countries in Latin America and in around 20 French or Portuguese speaking African countries.

Bial is strongly committed to therapeutic innovation investing approximately 20% of its turnover in research and development every year. Key research areas for Bial are the central nervous system, the cardiovascular system and allergology. Bial currently has several other innovative programs under development, which the company expects to bring to the market within the next years, thereby strengthening its position throughout Europe.