卫材（Eisai）和百健艾迪（Biogen Idec）3月5日联合宣布，双方已签订合作协议，开发和商业化卫材研发管线中的2种阿尔茨海默氏症（AD）药物：E2609和BAN2401。同时，该项协议也为卫材提供了选择权，共同开发和商业化百健艾迪管线中的2种AD药物：抗β淀粉样蛋白（Aβ）抗体BIIB037和一种抗tau蛋白的单克隆抗体。
E2609是一种β位点淀粉样前体蛋白裂解酶（BACE）抑制剂，BAN2401则是一种Aβ抗体，这2种药物均有望减少AD患者大脑中的Aβ斑块，并阻止新斑块的形成，具有改善患者症状和抑制病情恶化的潜力。
在E2609和BAN2401的联合开发中，卫材将领导研究的实施和监管，同时将寻求全球范围内的上市许可申请。而在主要市场，如美国和欧盟，卫材将和百健艾迪联合销售药物。百健艾迪将支付一笔预付款和固定金额的开发、审批、商业化里程碑款项。该协议还包括双方在日本联合开发和商业化活动的额外一次性付款。
关于
E2609是一种实验性新一代口服阿尔茨海默氏症（AD）候选药物，由卫材内部发现，被认为能够抑制Aβ生成中的一种关键酶BACE。通过抑制BACE，E2609能够减少大脑中的Aβ蛋白，具有改善症状和延缓疾病进展的潜力。目前，该药正在准备进入II期临床。
关于
BAN2401是一种人源化单克隆抗体，由卫材和BioArctic Neuroscience公司之间的战略研究联盟开发。BAN2401被认为能够选择性结合、中和并消除可溶性、有毒性Aβ的聚集。因此，BAN2401具有免疫调节的作用，具有抑制病情恶化的潜力。目前，该药正处于II期临床。
关于
BIIB037是一种抗Aβ人单克隆抗体，由百健艾迪从Nurimmune公司授权获得。据认为，BIIB037能够结合并消除AD患者大脑中的毒性淀粉样斑块，从而潜在地抑制疾病的恶化。目前，该药正处于Ib期临床。
关于 Biogen Idec ：
Biogen Idec，位于美国麻塞诸塞州的生物科技公司，专门从事神经系统疾病、自体免疫性疾病和癌症药物的开发。建立于2003年，由Biogen 与 Idec 合并而成。
百健艾迪携手卫材加码 AD药竞争
百健艾迪公司（Biogen Idec）加大了对阿尔茨海默症（AD）药物的研发力度。近日，百健艾迪与日本卫材公司（Eisai）签订了协议，双方合作开发卫材内部的两只阿尔茨海默症药物E2609和BAN2401。同时，协议也给予卫材选择权，与百健艾迪共同开发和商业化后者的两只阿尔茨海默症药物抗淀粉样蛋白抗体biib037和一种抗tau蛋白单克隆抗体。
在E2609和BAN2401的联合开发中，卫材将领导研究的实施和监管，同时将寻求全球范围内的上市许可申请。而在主要市场，如美国和欧盟，卫材将和百健艾迪联合销售药物。百健艾迪将支付一笔预付款和固定金额的开发、审批、商业化里程碑款项。该协议还包括双方在日本联合开发和商业化活动的额外一次性付款。
百健艾迪对E2609和BAN2401下了很大赌注。E2609是卫材发现的一种药物，即将进入Ⅱ期临床以确定其作为β位点淀粉样前体蛋白裂解酶（BACE）抑制剂的优点，这也是目前研究阿尔茨海默症药物炙手可热的方法。通过抑制BACE，E2609能够减少大脑中的β淀粉样蛋白。BAN2401由卫材和BioArctic Neuroscience公司合作开发，是治疗第二阶段阿尔茨海默症患者的一种免疫疗法，其机制是在阿尔茨海默症患者大脑中经常发现的有毒蛋白质。研究人员一直在寻找解决有毒蛋白质在脑部结块的方法，并且防止它们首先在脑部形成。
随着世界人口的增加，阿尔茨海默氏症患者人数也越来越多。在礼来公司、强生公司和辉瑞公司的研究开发相继失败之后，研究人员越来越集中于疾病的上游开发阶段，希望为患者找到一种治疗轻中度阿尔兹海默症的可靠方法。
目前，作为BACE研究的领头羊，默沙东加速了旗下BACE药物的后期研究；阿斯利康拥有BACE的一个候选药物azd3293，该药正处于临床研究阶段，但遭遇了一些明显挫折。而礼来在BACE抑制剂ly2886721上的失败，引起了广泛关注，因为患者在服药后出现了肝中毒迹象。与此同时，罗氏最近悄悄地削减了RG7129的早期计划，且没有提供任何解释。
同时，该领域的科学家也提出了一些严肃的问题，质疑BACE药物潜在的意想不到的后果，包括这种方法是否会影响到患者的髓鞘形成，从而威胁患者生命安全。
EISAI AND BIOGEN IDEC ENTER COLLABORATION TO DEVELOP AND COMMERCIALIZE ALZHEIMER’S DISEASE TREATMENTS
Wednesday, March 5, 2014 2:33 am EST
- Agreement to Enhance R&D Capabilities and Pipeline Aimed at Creating New Therapies to Suppress Alzheimer’s Disease Progression -
TOKYO & CAMBRIDGE, Mass.Eisai Co., Ltd. (TSE: 4523) and Biogen Idec(NASDAQ: BIIB) announced today that they have entered into a collaboration to develop and commercialize two of Eisai’s clinical candidates for Alzheimer’s disease (AD), E2609 and BAN2401. The agreement also provides Eisai with an option to jointly develop and commercialize two of Biogen Idec’s candidates for AD, the anti-amyloid beta (Aβ) antibody BIIB037 and an anti-tau monoclonal antibody.
The collaboration initially will be centered on the co-development and co-commercialization of Eisai’s two candidates: E2609, a β-site amyloid precursor protein cleaving enzyme (BACE) inhibitor, and BAN2401, an anti-Aβ antibody. These candidates have the potential to reduce Aβ plaques that form in the brains of patients with AD and to stop the formation of new plaques, potentially improving symptoms and suppressing disease progression.
Eisai will serve as the operational and regulatory lead in the co-development of E2609 and BAN2401 and will pursue marketing authorizations for both compounds worldwide. In major markets, such as the United States and the European union, Eisai and Biogen Idec will also co-promote the products following marketing approval. Both companies will share overall costs, including research and development expenses, with Eisai booking all sales for E2609 and BAN2401 and with profits to be split between the companies.
Biogen Idec will provide Eisai with an upfront payment and a fixed amount of development, approval and commercial milestone payments. The agreement also includes options for Eisai to receive an additional one-time payment from Biogen Idec related to joint development and commercialization activities in Japan.
“This collaboration is a natural fit with our mission to develop therapies for patients with severe neurodegenerative diseases. Eisai’s candidates have demonstrated compelling early data and complement our AD research while extending our pipeline in this critical area,” said George A. Scangos, Ph.D., chief executive officer of Biogen Idec. “Eisai is a pioneer in successfully developing and commercializing AD treatments. This history, combined with their strong scientific heritage, geographical reach and unwavering commitment to the AD community, makes Eisai an excellent collaboration partner to help drive our mission.”
Eisai Co., Ltd. President & CEO Haruo Naito added, “There exists an urgent need to develop AD therapies that suppress disease progression in order to effectively alleviate both the emotional burden of suffering and uncertainty experienced by patients and their families, as well as the financial burden on overall society in terms of the huge costs of nursing and patient care. Eisai remains deeply focused on the development of such therapies based on the knowledge and experience it has accumulated through its development of the anti-AD agent Aricept®. Through our collaboration with Biogen Idec, a company that specializes in neurodegenerative diseases, I believe we will be able to further enhance our existing R&D capacities for developing next-generation AD treatments, thereby accelerating the development of promising therapies and increasing the benefits provided to patients with AD worldwide.”
About E2609
E2609, discovered in-house by Eisai, is an investigational next-generation oral candidate for the treatment of AD that is believed to inhibit BACE, a key enzyme in the production of Aβ. By inhibiting BACE, E2609 decreases Aβ proteins in the brain, potentially improving symptoms and slowing disease progression. Currently, E2609 is undergoing preparations to enter Phase II clinical trials.
About BAN2401
BAN2401 is a humanized monoclonal antibody that is the result of a strategic research alliance between Eisai and BioArctic Neuroscience AB to identify a potential immunotherapy for AD. BAN2401 is believed to selectively bind to, neutralize and eliminate soluble, toxic Aβ aggregates that are thought to contribute to the neurodegenerative process in AD. As such, BAN2401 has the potential to have an immunomodulatory effect that may suppress the progression of the disease. Eisai obtained the global rights to study, develop, manufacture and market BAN2401 for the treatment of AD pursuant to an agreement concluded with BioArctic Neuroscience AB in December 2007. Currently, the compound is undergoing Phase II clinical trials.
About BIIB037
BIIB037 is an anti-Aβ human monoclonal antibody that is currently under investigation by Biogen Idec as a treatment for AD under a license from Neurimmune. It is believed that BIIB037 binds to and eliminates the toxic amyloid plaques that form in the brains of patients with AD, thereby potentially suppressing the progression of the disease. BIIB037 is currently undergoing a Phase Ib clinical trial.
About Eisai Co., Ltd.
Eisai Co., Ltd. is a research-based pharmaceutical company that discovers, develops and markets products worldwide. Guided by its corporate mission of “giving first thought to patients and their families, and to increasing the benefits that health care provides,” all Eisai employees aspire to meet the various needs of global health care as representatives of a “human health care (hhc) company” that is capable of making a meaningful contribution under any healthcare system. For more information about Eisai Co., Ltd., please visit www.eisai.com/.
About Biogen Idec
Through cutting-edge science and medicine, Biogen Idec discovers, develops and delivers to patients worldwide innovative therapies for the treatment of neurodegenerative diseases, hemophilia and autoimmune disorders. Founded in 1978, Biogen Idec is the world’s oldest independent biotechnology company. Patients worldwide benefit from its leading multiple sclerosis therapies. For product labeling, press releases and additional information about the Company, please visit www.biogenidec.com.
Biogen Idec Safe Harbor Statement
This press release contains forward-looking statements, including statements about Biogen Idec’s expectations and mission to develop treatments for people with Alzheimer’s disease, through its collaboration with Eisai. These forward-looking statements may be accompanied by such words as “anticipate,” “believe,” “estimate,” “expect,” “forecast,” “intend,” “may,” “plan,” “will” and other words and terms of similar meaning. You should not place undue reliance on these statements. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including risks and uncertainties associated with drug development and commercialization, Biogen Idec’s dependence on third parties over which it may not always have full control, and the other risks and uncertainties that are described in the Risk Factors section of Biogen Idec’s most recent annual or quarterly report filed with the Securities and Exchange Commission. These statements are based on current beliefs and expectations and speak only as of the date of this press release. Biogen Idec does not undertake any obligation to publicly update any forward-looking statements.
免责声明：
本文仅供专业人士学术交流探讨，不作为诊疗及用药依据。
如有侵权，请联系我们删除