罗氏、施贵宝和默沙东，谁将成为免疫疗法治疗黑色素瘤胜利者？

[size=1.1em]作者：[size=1.1em]yangtao[size=1.1em]来源：[size=1.1em]生物谷2014-3-25 7:38:55

关键词： 罗氏 施贵宝 默沙东 免疫疗法 PD-1 黑色素瘤

                               
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2014年3月25日讯 /生物谷BIOON/ --近年来肿瘤免疫疗法的概念方兴未艾，而这种方法也成为治疗黑色素瘤这一可怕疾病的希望之一。作为生物制药领域的巨头，罗氏、施贵宝和默沙东都在这一领域投入巨大的人力物力，希望在这一领域拔得头筹。而目前三家公司有关PD-1蛋白和PD-L1蛋白的相关药品都正在紧锣密鼓的研制中。施贵宝的nivolumab目前正处于治疗黑色素瘤的临床而起研究阶段，而默沙东的MK-3475也已经成为公司的主要研究项目，另一方面，罗氏RG7445也取得了令人瞩目的成绩。不过现在还很难说谁能最终笑到最后，因为这三种药物都预计能够在2015年末获得批准。而有分析人士认为相关领域的市场空间将高达125亿美元之多。另一方面，PD-1药物疗法的价格也相当高昂，据相关人士估计这一类产品的价格可能达到24万美元一疗程。（生物谷Bioon.com）

详细英文报道：

As Roche ($RHHBY), Bristol-Myers Squibb ($BMY) and Merck ($MRK) race to the market with promising immunotherapies for advanced melanoma, analysts' sky-high sales estimates for the new drug class may soon have to reckon with revenue-slashing competition and fast-growing pricing pressures.

As The Wall Street Journal reports, all three companies are moving toward regulatory filings for their respective treatments, which target the lock-and-key proteins PD-1 and PD-L1 to expose cancer cells to an immune system attack. Bristol-Myers has garnered the most attention with its nivolumab, which posted impressive Phase II survival rates in inoperable melanoma, while Merck's similar MK-3475 has quickly become the slow-footed drug developer's top R&D priority, and Roche's RG7446 has racked up impressive results of its own.

All three could win FDA approval before the end of 2015, and, thanks to stellar results and the potential for combination treatments, analysts expect the drugs to peak at about $12.5 billion a year, WSJ notes, with Bristol-Myers claiming the lion's share. None of the companies is ready to talk about pricing, but Citi told the newspaper that PD-1 treatments could cost as much as $240,000 once they make it to market, far outstripping the costs of current vanguard therapies like Bristol-Myers' Yervoy.

And that's where market forces could intrude and put a damper on all the business-side excitement over the new drugs.

For one, with all three PD-1/PD-L1 blockers expected to hit the market at around the same time, competition and discounting may undercut some of the rosiest projections of peak sales. More importantly, though, the mounting public fervor over the cost of medications could alter expectations for all three companies. Some of the most impressive immunotherapy data have come from studies combining newfangled therapies with other pricey cancer meds, meaning the highest odds of patient success will likely come from doubling up six-figure treatment regimens. To date, payers have been willing to shell out for efficacious cancer drugs, but the expected leap in costs for PD-1 drugs could create a "completely unsustainable" pricing situation, Institute of Cancer Research Deputy CEO Paul Workman told the WSJ.

As Gilead Sciences ($GILD) has been made well aware, public concern about drug pricing is peaking at the moment, and, by the time Bristol-Myers, Merck and Roche get started on commercialization, they may be looking at a different landscape.

(责任编辑：lishuheng)