赛诺菲（Sanofi）近日接受路透社采访时表示，希望能通过内部新产品及潜在的外部收购，使其罕见病研发单元健赞（Genzyme）成为多发性硬化症（MS）市场的领导者。赛诺菲对其2个多发性硬化症药物Lemtrada和Aubagio的成功商业化自信满满，同时表示，正在积极的猎取外部收购。该公司拒绝透露潜在的收购目标，但其表示，Gemzyme一直在寻找真正创新的产品，并正与一些公司谈判，目前也在权衡选择。当前，来自囊中羞涩的各国政府寻求限制医疗开支的定价压力，以及仿制药的激烈竞争，促使制药公司在全球范围内对其业务重新洗牌，并引发了新一波并购狂潮。
早在2011年，因非常看好Genzyme的产品组合及市场前景，赛诺菲耗资200亿美元大手笔收购了Genzyme。目前，Genzyme已成为其核心新兴业务，同时赛诺菲正指望Genzyme能帮助摆脱数个重磅药物专利悬崖所带来的重创，如血液稀释剂Plavix。今年上半年，Genzyme单元的销售额已增长25%。赛诺菲收购Genzyme，主要看中了其多发性硬化症药物Lemtrada的前景，该药是一种注射药物，用于治疗复发缓解型多发性硬化症，这是多发性硬化症中最常见的一种类型。而目前多发性硬化症市场已被百健艾迪（Biogen Idec）、诺华（Novartis）和梯瓦（Teva）统治。
Lemtrada已在欧洲上市，但尚未获FDA批准，此前，该药因安全性和临床研究质量问题被FDA拒之门外。赛诺菲于今年年初已重新向FDA提交了新药申请，而FDA预计将在今年第四季度做出审查决定。
Lemtrada通过静脉输注给药，该药旨在重新编程免疫系统，但这种治疗方法使机体更易遭受其他疾病。目前，尽管医生和患者对口服疾病修饰疗法表现出了高涨的热情，如诺华的Gilenya和百健艾迪的Tecfidera，但注射型产品仍然是当前重要的治疗方案，同时也是目前MS管线的重要组成部分。因此，鉴于Lemtrada持续降低复发风险的优越性，该药仍有望在多发性硬化症市场中分一杯羹。详见生物谷推荐阅读《2023年全球多发性硬化症（MS）市场将达200亿美元》
本周，赛诺菲将向多发性硬化症研究和治疗欧洲委员会（ECTRIMS）提交Lemtrada一揽子新数据，在2项关键III期扩展研究中，既往接受过Lemtrada治疗的患者群体，仍保持低水平的复发率和持续致残累积，这些积极数据将进一步支持Lemtrada良好的疗效/风险属性。ECTRIMS年会上，赛诺菲还将公布Aubagio的新数据，该药是一种口服多发性硬化症药物，已获FDA和欧盟批准，业界对该药更为看好。
根据路透社数据，分析师预计，Aubagio在2018年的销售峰值将达到12亿美元，而Lemtrada的销售额仅为4.37亿美元。而赛诺菲则认为，业界低估了Lemtrada的市场前景，并认为，Aubagio和Lemtrada均有望成为多发性硬化症市场的重磅产品。
多发性硬化症是一种慢性自身免疫性疾病，全球患者总数超过2000万，美国有50多万患者，该病会攻击神经系统，导致肌肉无力、疼痛和认知困难。
英文原文：Sanofi keeps the faith in MS and eyes a new dawn for Genzyme
Despite an FDA rejection and changing winds in the field of multiple sclerosis, Sanofi ($SNY) believes its Genzyme unit is on an upward trajectory, talking up potential deals and could-be blockbusters for its pricey acquisition.
As it stands, the state of the Sanofi-Genzyme unio is likely not what management hoped for three years ago. Back in 2011, Genzyme used the potential of its top prospect, the MS treatment Lemtrada, to drive up its asking price, eventually convincing Sanofi to pony up more than $20 billion for the company. But the promise that swayed Sanofi wasn't enough for the FDA, which stingingly rejected the annual treatment in December, telling the company to conduct another costly, time-consuming Phase III trial before coming back.
But Sanofi remains bullish as ever, maintaining its optimism for both Lemtrada and Genzyme as a whole. On the former, the company has resubmitted its injected drug without that requested new trial, expecting to get a second opinion from the FDA in the fourth quarter of this year. This week, the company is touting new data from a Lemtrada extension study, in which the drug's effects proved stable over four years with no new risks.
Meanwhile, the MS field has drastically changed since Sanofi signed on to carry the torch for Lemtrada. Tecfidera, an oral treatment from Biogen Idec ($BIIB), debuted in April 2013 and has minted more than $2 billion in sales ever since, shifting a landscape long dominated by Teva ($TEVA) and its soon-to-come-off-patent Copaxone. Analysts expect oral therapies, including Sanofi's own Aubagio, to gradually outpace the injected treatments that largely make up the standard of care.
But despite the crowded, evolving market, Genzyme sees a space for Lemtrada to compete and thrive, executives told Reuters.
"I'm confident in the U.S. approval and I'm confident in how the product will perform and be utilized," Genzyme's MS and neurology head Mike Panzara told the news service. "... The efficacy is just too good."
Beyond its MS franchise, the Boston-headquartered rare disease stalwart is "very active" on the M&A scene, Senior Vice President Bill Sibold told Reuters, talking up the weight of Sanofi's checkbook as the company hunts for external innovation.
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