新药备受争议，但这家公司却仍不放弃

有关渤健（Biogen）和其引发争议的治疗阿尔茨海默病的药物，将有更多好戏上演。在加州圣迭戈面对一大群研究阿尔茨海默病的科学家时，渤健展示了其名为aducanumab药物的新数据，称这种药物可以缓解阿尔茨海默病患者的症状。在详细的阐述中，公司称临床试验显示，使用该药物最高剂量的患者，在认知能力的退化方面要比服用无效对照剂的患者更加缓慢。

今年10月，渤健宣布重新启动该药物研究，并将寻求监管机构许可，震惊了整个生物医药界，此后也引来了诸多的怀疑。因为几个月前，渤健曾经宣布放弃推出该药物，并终止对该药物的研究，因为试验结果令人失望。

如今，这家位于马萨诸塞州剑桥市的生物科技公司称，这一药物有效，他们已经重拾信心，并已经向美国食品与药品管理局申请许可。申请结果预计将在2020年公布。如果监管机构同意，那么该药物将成为能够实际帮助日益衰弱的阿尔茨海默病患者的首种药物。

随着故事的起伏，渤健的股价也随着每条新消息涨涨跌跌，而华尔街也是莫衷一是。

当我在几周前与渤健的首席执行官米格尔·维纳特索斯对话时，他显得积极而充满信心。他说，他觉得令人鼓舞的是，阿尔茨海默病的患者在服用了渤健药物18个月后，出现了“明显的”好转迹象。

“我们要诚实、谦虚，并遵守监管流程。”他说，“在庆祝之前，我们得先等一等。但确实有希望。”

那么，如果维纳特索斯成功地将这款突破性的治疗阿尔茨海默病的新药推向市场，它的售价将是多少呢？一开始，他推脱说：“谈价格还太早。”

考虑再三后，他提议说，这种药物投放市场后，将采用一种更加有创意的支付方式，用以覆盖数百万因为阿尔茨海默病而丧失记忆的患者。据美国疾控中心的数据，在美国患有阿尔茨海默病的患者人数，到2060年时将翻两番，达到1400万人。

“这需要多方努力以及政府参与，”他说，“我们公司和管理层，将对创新的商业方式也保持开放态度，让药物治疗覆盖更多的人群。我将竭尽所能破除那种旧式的缴费才治疗的模式，这种模式在治疗大范围人群时已经显示出局限性。”（财富中文网）

译者：宣峰

There was more drama this week about Biogen and its controversial Alzheimer’s drug. Speaking before a large crowd of Alzheimer scientists gathered in San Diego, California, Biogen showed new data that its drug, called aducanumab, could offer relief to people struggling with Alzheimer’s. In a detailed presentation, the company said that in clinical trials, patients receiving the highest dose of the drug had slower declines in their cognitive abilities than patients who received a placebo.

There’s been plenty of skepticism about those claims ever since Biogen shocked the biotech world in October when it announced it was resurrecting its research and would also seek regulatory approval for the drug. Just a few months earlier, Biogen said it had given up on aducanumab and terminated its research because of disappointing results.

Now the Cambridge, Massachusetts-based biotechnology company says it has renewed confidence that the drug works and has returned to the Food and Drug Administration for approval. A decision is expected in 2020. If regulators give the okay, the drug could be the first treatment that actually helps people with the debilitating Alzheimer’s disease.

As the saga continues, Biogen shares have been soaring and tumbling on every new piece of information, and opinions on Wall Street have been mixed.

But when I spoke with Biogen CEO Michel Vounatsos a few weeks ago, he was positive and hopeful. What he finds encouraging, he says, is that Alzheimer’s patients who have received Biogen’s drug treatment showed “significant” improvement after 18 months.

“We have to be modest, humbled, and follow the regulatory process now,” he tells me. “We have to wait before we celebrate. But there is hope.”

So, if Vounatsos succeeds in delivering a breakthrough drug to treat Alzheimer’s, what will it cost? At first, he pushes back saying, “it’s too early to speak about cost.”

After some thought, he suggests that it will take a more innovative payment model to cover the millions of people suffering from Alzheimer’s memory loss. According to the CDC, the number of people living with Alzheimer’s disease is expected to nearly triple to 14 million people in the United States by 2060.

“This will take multi-party and engagement with authorities,” he says. “And the company and its leadership will be open to innovative contracting in order to treat the larger population. I will do everything I can in order to disrupt from the old models of fee-for-service that have certainly demonstrated their limitation in terms of treating a broader population. ”