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礼来投5亿与阿斯利康合作开发成功率仅9%的AD药物AZD3293
阿尔茨海默氏症（AD）一直是新药研发的重灾区，据PhRMA统计，1998-2011年，13年中新药研发战绩3胜101败，满满都是失败的惨淡景象，礼来自己投资超10亿美元的单抗药solanezumab也在III期惨遭失败。近日，礼来又投5亿美元，押注阿斯利康AD新药AZD3293，然而该药成功率仅9%，不禁让我们对礼来瞬间致敬。
阿斯利康（AZN）和礼来（Eli Lilly）近日宣布，双方已达成战略联盟，合作阿尔茨海默氏症（AD）药物AZD3293，该药是一种口服β-淀粉样前体蛋白裂解酶(BACE或β分泌酶)抑制剂，正调查用于早期阿尔茨海默氏症（AD）的治疗。当前，阿斯利康的研发管线主要集中于癌症、糖尿病、呼吸系统和心血管系统疾病，神经科学已不再是核心领域，这也是其积极寻找合伙伙伴的原因。因此，早在今年5月，阿斯利康就表示，正在为AZD3293物色合作伙伴，将该药推进至III期临床。 在对抗辉瑞1180亿美元收购时，阿斯利康就曾标榜AZD3293具有重磅潜力，根据其战略防御文件，阿斯利康认为，尽管研发AZD3293的成功率仅为9%，但一旦上市，年销售额将突破50亿美元。阿斯利康和礼来计划迅速推进AZD3293至II/III期临床，调查用于早期阿尔茨海默氏症的疗效和安全性。许多专家认为，在疾病早期给予药物治疗，可能是成功治疗阿尔茨海默氏症的关键。 阿尔茨海默氏症的特征是，淀粉样蛋白斑块（由β淀粉样蛋白组成）在大脑中积累。BACE是与β淀粉样蛋白形成相关的蛋白酶，抑制BACE，有望阻止淀粉样蛋白斑块的形成，并最终减缓疾病的进展。AZD3293是一种口服强效选择性小分子BACE抑制剂，在I期研究中，已被证明能够显著且呈剂量依赖性地降低阿尔茨海默氏症患者和健康志愿者脑脊液中β淀粉样蛋白的水平。阿斯利康于2014年初宣布了AZD3293进入临床试验注册的计划。 根据协议条款，礼来将支付阿斯利康高达5亿美元的开发、监管里程碑款项，首笔5000万美元的里程碑款预计将于2015年上半年支付。双方将平摊AZD3293的研发和商业化成本，也将平分该药的全球净收入。礼来将领导临床试验，并与阿斯利康神经科学创新单元的科学家合作，阿斯利康则负责AZD3293的生产。 2年前，强生和辉瑞的单抗药物bapineuzumab以及礼来的单抗药物solanezumab均在III期临床惨遭失败，这2种药物研发投入均超过10亿美元，在AD新药研发领域，是非常沉重的打击。而BACE抑制剂是另一种很有前途的新方法，已取代单抗药物站在了阿尔茨海默氏症药物研发的舞台中心。当前，默沙东（Merck & Co）是BACE抑制剂领域的领导者，其实验性药物MK-8931的首批III期临床数据预计将于2017年左右获得。 阿尔茨海默氏症（AD）是一种进行性发展的致死性神经退行性疾病，临床表现为认知和记忆功能不断恶化，日常生活能力进行性减退，并有各种神经精神症状和行为障碍。阿尔茨海默氏症是最常见形式的老年痴呆症，约占老年痴呆症病例的60%-80%。根据阿尔茨海默氏症协会数据，目前全球范围内约有4400万人患有老年痴呆症，每年的医疗费用已达到2000亿美元，鉴于当前AD治疗选择仅限于疗效欠佳的对症治疗药物，AD患者总数预计将在2030年达到7500万，在2050年达到1.35亿，治疗费用更将达到12000亿美元。 目前，市面上仅有5种药物获批用于阿尔茨海默氏症的对症症状，尚无一种药物能够逆转疾病进程，这也造就了巨大的医疗需求以及新药的重磅销售潜力。 此前，美国药品研究与制造商协会(PhRMA)对1998-2011年间的阿尔茨海默氏症药物研发进行了统计，数据表明，这13年中，制药商已取消或终止101个新药开发，只有3种药物上市，研发成功失败比仅为1:34，已上市的3种新药也仅限于阿尔茨海默氏症的对症治疗。尽管新药研发路途艰难，但尚无迹象表明，生物医药行业将要放弃阿尔茨海默氏症领域的新药研发。 阿尔茨海默氏症领域的诸多挫折确实令很多人失望，包括开展研究的科学家，但这些不成功的尝试却是至关重要的垫脚石，帮助推动对这种极其复杂疾病的认识，同时也在帮助重新定向研究，提供新的线索，让科学不断向前迈进。原文链接http://news.bioon.com/article/6658863.html 英文原文：AstraZeneca and Lilly announce alliance to develop and commercialise BACE inhibitor AZD3293 for Alzheimer’s disease Tuesday, 16 September 2014 AstraZeneca and Eli Lilly and Company (Lilly) today announced an agreement to jointly develop and commercialise AZD3293, an oral beta secretase cleaving enzyme (BACE) inhibitor currently in development as a potential treatment for Alzheimer’s disease. The progression of Alzheimer’s disease is characterised by the accumulation of amyloid plaque in the brain, which is comprised of peptides called amyloid beta. BACE is an enzyme associated with the development of amyloid beta. Inhibiting BACE is expected to prevent the formation of amyloid plaque and eventually slow the progression of the disease. AZD3293 is an oral, potent and selecive small molecule inhibitor of BACE that has been shown in Phase I studies to significantly and dose-dependently reduce levels of amyloid beta in the cerebro-spinal fluid of Alzheimer’s patients and healthy volunteers. AstraZeneca announced earlier in 2014 its plan to move AZD3293 into registration trials. Under the terms of the agreement, Lilly will pay AstraZeneca up to $500 million in development and regulatory milestone payments. AstraZeneca expects to receive the first milestone payment of $50 million in the first half of 2015. The companies will share all future costs equally for the development and commercialisation of AZD3293, as well as net global revenues post-launch. AstraZeneca and Lilly aim to progress AZD3293 rapidly into a Phase II/III clinical trial in patients with early Alzheimer’s disease. Lilly will lead clinical development, working with researchers from AstraZeneca’s Innovative Medicines Unit for neuroscience, while AstraZeneca will be responsible for manufacturing. The companies will take joint responsibility for commercialisation of AZD3293. Mene Pangalos, Executive Vice President, Innovative Medicines & Early Development at AstraZeneca, said: “Alzheimer’s disease is one of the biggest challenges facing medical science today and BACE inhibitors have the potential to target one of the key drivers of disease progression. We are looking forward to working with Lilly, an organisation with a long term commitment to and expertise in treating Alzheimer’s disease. We believe that, by combining the scientific expertise from our two organisations and by sharing the risks and cost of late stage development, we will be able to accelerate the advancement of AZD3293 and progress a promising new approach to support the treatment of Alzheimer’s patients around the world. "What’s more, this alliance will enable AstraZeneca to further sharpen our strategic focus on core therapeutic areas, while leveraging external collaborations to maximise the potential of the strong science we have in our growing pipeline.” “Lilly has been committed to research in Alzheimer’s disease for more than 25 years, and we’re dedicated to developing new medicines that can change and modify the course of this devastating disease,” said David Ricks, Lilly Senior Vice President and President, Lilly Bio-Medicines. “Lilly’s pipeline of potential medicines and diagnostic agents targeting the known hallmarks of the disease has been bolstered today by this alliance with AstraZeneca, which shares our passion to bring new medicines to patients suffering from this debilitating illness. This alliance moves us one step closer to achieving our goal of making Alzheimer’s dementia preventable by 2025.” The agreement is subject to customary terms and conditions. It will have no impact on AstraZeneca’s 2014 Core Earnings per Share.
NOTES TO EDITORS about AZD3293 AZD3293 is an oral, potent and selective small molecule inhibitor of BACE that has been shown in Phase I studies to significantly and dose-dependently reduce levels of amyloid beta in the cerebro-spinal fluid of Alzheimer’s patients and healthy volunteers. about Alzheimer’s disease Alzheimer's disease is a fatal illness that causes progressive decline in memory and other aspects of cognition. It is the most common form of dementia, accounting for 60 to 80 percent of dementia cases. According to the Alzheimer’s Association, there are currently an estimated 44 million people living with dementia worldwide. The number of people affected by dementia is expected to be more than 75 million in 2030 and 135 million in 2050.
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