2014年12月3日讯 /生物谷BIOON/ --日本大冢（Otsuka）近日宣布将耗资35亿美元收购美国药企Avanir。目前，该笔交易已获双方董事会批准，预计将于2015年第一季度完成。根据已达成的协议，交易完成后，Avanir将作为大冢美国（Otsuka America）的独立子公司并继续按现有结构运营，并与大冢合作进一步增强中枢神经系统（CNS）相关疾病的研发和营销。
大冢总裁兼董事长岩本太郎表示，将大冢在精神疾病领域的经验和业务与Avanir在神经系统疾病中的专长结为一体，将使大冢成为一家真正意义上的全球中枢神经系统（CNS）巨头。以假性延髓情绪（PBA）为代表，Avanir在未开发医学疾病领域的药物研发创造力及执行力，完美符合大冢的企业文化，我们非常钦佩和尊重Avanir的创新、远见及执行力，希望能够共同成长。
Avanir是一家总部位于美国加州的生物制药公司，专注于研发治疗中枢神经系统疾病的药物。已上市产品包括Nuedexta，该药是FDA批准的首个也是唯一一个治疗假性延髓情绪（pseudobulbar effect，PBA）的药物。PBA俗称 “强哭强笑”，通常出现在神经系统疾病或受伤患者中，特征为难以控制的强哭强笑发作，由于其不可预知的情绪失控，这些病人经常遭遇尴尬，导致人际关系混乱和社会隔离等不良后果。
此外，Avanir也正在开发另一款复方药物AVP-923用于阿尔茨海默氏症（AD）的治疗。AVP-923由止咳药中常见的一种成分右美沙芬（dextromethorphan，用于止咳）和一种心脏药物奎尼丁（quinidine，用于控制心律不齐）组成的复方药，在一项II期临床中已被证明能够平息阿尔茨海默氏症（AD）患者的激动情绪。
Avanir公司的这种做法遭到了一些行业分析师的嘲笑。然而，一直专注于中枢神经系统疾病的大冢，却看中了AVP-923在阿尔茨海默氏症领域的巨大潜力。
几个月前，Avanir公司公布了AVP-923 II期阿尔茨海默氏症研究的积极数据，股价飙升45%。不过，该复方药在疼痛研究中表现不尽如意，但Avanir认为已经做好准备启动关键性III期阿尔茨海默氏症临床研究，同时将推动针对一系列难治性疾病（包括帕金森病、抑郁症和自闭症）的临床项目。
就在几天前，Avanir研发的药物-装置组合物AVP-825（OptiNose）被FDA拒绝，该组合物旨在通过鼻腔递送sumatriptin（舒马曲坦）粉末，开发用于偏头痛的治疗。FDA已要求开展额外的测试评估药物递送装置的安全性。
英文原文：Otsuka buys Avanir and its portfolio of repurposed generics for $3.5B
Avanir has made something of a reputation for itself by mixing a pair of generics--a cough suppressant and an old heart medicine--into a new elixir that can calm an emotional outburst. And Japan's Otsuka has stepped in to snap up the company, its product and a pipeline of repurposed meds for a hefty $3.5 billion.
Formulated as the drug Nuedexta, the Aliso Viejo, CA-based biotech ($AVNR) has been selling its drug as a treatment for pseudobulbar effect, a condition characterized by uncontrolled outbursts of intense crying or laughing. And the same concoction--a mix of the cough suppressant dextromethorphan (commonly found in NyQuil, among other cough meds) and the generic quinidine (used to control irregular heartbeats) into AVP-923--has demonstrated that it can calm agitated Alzheimer's patients in a mid-stage trial.
That approach has earned a number of scoffs from analysts. But Otsuka--which has remained focused on mental health--sees plenty of potential in Alzheimer's, a field marked by unproven theories and littered with the debris of failed clinical studies.
A couple of months ago the biotech's shares shot up 45% on the positive bottom line for its Alzheimer's study. The same mix had failed a study for pain, but the company believes it's ready to target a pivotal trial for Alzheimer's while advancing a slate of trials for a range of hard-to-treat conditions that includes Parkinson's, depression and autism.
Just days ago Avanir's drug-device combo that delivers a shot of sumatriptan--another aging, repurposed generic--to treat migraines was shot down by regulators, as expected. But the biotech has not given up on AVP-825, or OptiNose, and is planning to come back with a response to the FDA's list of issues.
"As we bring together Otsuka's experience and business track record in the area of mental illnesses with Avanir's strengths in neurologic diseases, we believe that we can evolve into a truly global CNS pharmaceutical company," says Otsuka Pharmaceutical President and Representative Director Taro Iwamoto. "Avanir's creativity and proven execution on drug discovery and development for largely unexplored medical indications, typified by PBA, represents a hand-in-glove fit with Otsuka's culture. We admire and respect Avanir's innovation, vision, and execution and want to continue to grow together."