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危言耸听还是不差钱?塔夫茨药物开发研究中心宣称药物平均开发成本达到29亿美元!

  1. 塔夫茨
  2. 成本
  3. 投资
  4. 药物研发

来源:生物谷 2014-11-20 09:16

药物开发一向被认为是种高风险高回报的投资领域。一直以来,无论是小型生物医药公司还是像辉瑞、罗氏等生物医药巨无霸在药物研发中都遭受了不少挫折。

2014年11月19日讯 /生物谷BIOON/ --药物开发一向被认为是种高风险高回报的投资领域。一直以来,无论是小型生物医药公司还是像辉瑞、罗氏等生物医药巨无霸在药物研发中都遭受了不少挫折。而药物开发过程中需要大量的持续不断的资金支持也是众所周知的事情,这也是为什么这两年生物医药公司IPO市场火爆的原因之一。

不过,最近塔夫茨药物开发研究中心无疑在这一问题上又引起了新的争论。塔夫茨药物开发研究中心在调查了10家著名医药企业的106个随机的药物研究项目后得出结论,如今生物医药公司开发一种新药物的成本已经达到了29亿美元之多。而塔夫茨药物开发研究中心上一次类似研究的结果是10亿美金,增长了近300%。

塔夫茨药物开发研究中心表示在进行计算时,研究人员不仅仅考虑了金钱的支出(14亿美元),还将药物研发的时间成本也考虑在内(11.6亿美元)。药物的批准后研究也在这一数字里贡献了3亿美元左右。研究人员介绍说,这一增长的原因有许多,例如药物临床研究规模的扩大、药物的对比实验以及一些神经退行性疾病和慢性病的药物开发项目的进行。

这一结果在生物产业界引起了轩然大波。一方面一些公司借此批评FDA将药物审批的门槛设得过高,对实验的数据要求过多;另一方面分析人士认为这一数字存在着很大水分,甚至会影响到投资者的热情,不利于产业发展。葛兰素史克公司的CEO Andrew Witty在听到这一消息时,甚至认为这一数字是不切实际的。而在这些人中流行着另外一个数字,就是研究一种药物的平均成本为1亿8千6百万美元。(生物谷Bioon.com)

详细英文报道:

The Tufts Center for the Study of Drug Development created the industry standard on R&D budgets when it pegged average R&D costs at close to $1 billion for each new drug. Today, Tufts researchers updated their figures and boosted the total to $2.9 billion.

Nothing creates an instant controversy in biopharma like a new study on average drug research costs. But before we take up the likely debate, let's look more closely at the figures used by Tufts.

The average out-of-pocket costs on R&D have hit $1.4 billion. And researchers at Tufts added in $1.16 billion for what it calls "time costs (expected returns that investors forego while a drug is in development)." Include another $312 million for postapproval research and the average costs spikes to $2.9 billion--a megablockbuster figure that would daunt any investor. And that's way up from their $802 million figure in 2003, a little more than $1 billion in today's inflation-adjusted figure, which helped get this discussion started.

Key factors for the huge tally: "Increased clinical trial complexity, larger clinical trial sizes, higher cost of inputs from the medical sector used for development, greater focus on targeting chronic and degenerative diseases, changes in protocol design to include efforts to gather health technology assessment information, and testing on comparator drugs to accommodate payer demands for comparative effectiveness data."

Lengthening development and approval times? Not responsible, says Joseph DiMasi, director of economic analysis at Tufts CSDD and principal investigator for the study.

"In fact," DiMasi said, "changes in the overall time profile for development and regulatory approval phases had a modest moderating effect on the increase in R&D costs. As a result, the time cost share of total cost declined from approximately 50% in previous studies to 45% for this study."

Big figures like this are frequently used to browbeat regulators, as lobbying groups accuse the FDA of demanding too much data or setting the bar too high on an approval. Tufts notes in its statement today that the figures were drawn from 10 pharma companies and 106 randomly selected therapies, which is also likely to serve as a lightning rod for critics who believe that quite a few pharma companies often notoriously pursue misguided R&D projects. Doctors Without Borders immediately blasted the study, calling it a snow job aimed at justifying exorbitant drug prices.

"The pharmaceutical industry-supported Tufts Center for the Study of Drug Development claims it costs US$2.56 billion to develop a new drug today; but if you believe that, you probably also believe the earth is flat," the group said in a caustic statement. "GlaxoSmithKline's CEO Andrew Witty himself says the figure of a billion dollars to develop a drug is a myth; this is used by the industry to justify exorbitant prices. We need to ask ourselves, if the CEO of a top pharmaceutical company says it's a myth that it costs a billion dollars to develop a drug, can we really take this new figure 2.56 billion seriously?"

Their favored figure: $186 million, including the cost of failure. And that helps illustrate the enormous gulf between two sides of this argument.

No one will dispute the fact that drug R&D is expensive. Even the most successful biotechs in the field rack up some big bills in the clinic, where finding the right data on the rights drugs remains a major challenge. But an average cost of $2.9 billion for each approval would probably put some biotechs out of business.

 

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