默沙东不言放弃 公布CETP药物Anacetrapib令人惊喜的3期临床试验结果！历时四年 三万人参加！

很久以来，许多分析师都认为默沙东公司的CETP（胆固醇酯转移蛋白）药物anacetrapib没戏了，因为同类里的其它三个药物都已接连折戟沉沙，代价昂贵，现在，该制药巨头成功地震撼了制药界！2017年6月27日上午有消息称，他们的药物顺利通过了一个历时四年、3万人参加的大型临床研究！取得了令人信服的有效性数据！

默沙东在一份简短的陈述中指出，anacetrapib显著地降低了已有效使用了降LDL疗法的高风险患者的冠状动脉疾病风险，这些风险包括冠状动脉死亡、心肌梗死和冠状动脉再血管化（revascularization）。

默沙东公司的股票在早盘交易中上涨了3％。

随着新的PCSK9胆固醇药物得到证实，心脏病研发在过去几年中已经发生了很大变化。 安进公司最近试图以积极的结果数据抢占市场领先地位，但到目前为止，数字并不令支付者信服。 重要的是，默沙东的简短声明指出他们仍在考虑是否提交NDA，这让每个人都渴望在8月29日举办的欧洲心脏病学会会议上欣赏REVEAL（Randomized EValuation of the Effects of Anacetrapib through Lipid modification）实实在在的数据。值得注意的是该公告也没有通常的来自公司顶尖研发高管诸如关于成功和帮助患者的潜力的欢呼词语。

但这是怎样的一个惊喜呀！

Evercom ISI的Umer Raffat说：“投资人没有期望默沙东的临床试验成功。我最近的投资者调查显示大家认为该试验成功的可能性只有20％。” 然而，Raffat也希望看到实在的数据来评估商业潜力，特别是考虑到默沙东的低调。而Leerink的Seamus Fernandez花费了一些时间对默沙东发布稿的字里行间进行了仔细的阅读，指出“新闻稿中的隐秘语言表明药物的风险/回报率尚不太明确”。

然而，默沙东证明，在这一领域，直到数据到来之前竞赛远未结束，即使罗氏、辉瑞和礼来在CETP上的首次巨大尝试都已经失利。

克里夫兰诊所的Steve Nissen在2015年评论道，“棒球比赛中你无法得到四次攻打的机会。” 在礼来停止其药物研发之后他就已经准备对该领域放弃了。 当时，伯恩斯坦的Tim Anderson是为数不多的几个仍然坚持的分析师之一，认为默沙东决定推进3期临床试验的决定仍然为成功留有一线希望。

热烈祝贺默沙东！医药研发，百折不饶！

药时代将继续跟踪报道。

欢迎欣赏默沙东发布的新闻稿！

Merck Provides Update on REVEAL Outcomes Study of Anacetrapib

June 27, 2017 06:55 AM Eastern Daylight Time

KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside of the United States and Canada, today announced that the REVEAL (Randomized EValuation of the Effects of Anacetrapib through Lipid modification) outcomes study of anacetrapib met its primary endpoint, significantly reducing major coronary events (defined as the composite of coronary death, myocardial infarction, and coronary revascularization) compared to placebo in patients at risk for cardiac events who are already receiving an effective LDL-C lowering regimen. The safety profile of anacetrapib in the early analysis was generally consistent with that demonstrated in previous studies of the drug, including accumulation of anacetrapib in adipose tissue, as has been previously reported. Merck plans to review the results of the trial with external experts, and will consider whether to file new drug applications with the U.S. Food and Drug Administration (FDA) and other regulatory agencies. The results of the REVEAL study will be presented at the European Society of Cardiology meeting on Aug. 29, 2017.

Anacetrapib is Merck’s investigational cholesteryl ester transfer protein (CETP) inhibitor. The REVEAL study is a randomized, double-blind placebo-controlled clinical trial to assess the efficacy and safety of adding anacetrapib to effective LDL-lowering treatment with atorvastatin for a median duration of at least 4 years among approximately 30,000 patients at high risk of cardiovascular events. REVEAL was designed and independently conducted by investigators at the Clinical Trial Service Unit (CTSU) at the University of Oxford, the trial’s regulatory sponsor, in collaboration with the TIMI Study Group based at Brigham and Women’s Hospital in Boston and Merck. Merck provided funding for REVEAL. Details on the REVEAL study design are available at clinicaltrials.gov: https://clinicaltrials.gov/show/NCT01252953.

About Merck

For more than a century, Merck, a leading global biopharmaceutical company known as MSD outside of the United States and Canada, has been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases. Through our prescription medicines, vaccines, biologic therapies and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to health care through far-reaching policies, programs and partnerships. Today, Merck continues to be at the forefront of research to advance the prevention and treatment of diseases that threaten people and communities around the world - including cancer, cardio-metabolic diseases, emerging animal diseases, Alzheimer’s disease and infectious diseases including HIV and Ebola. For more information, visit www.merck.com and connect with us on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Forward-Looking Statement of Merck & Co., Inc., Kenilworth, N.J., USA

This news release of Merck & Co., Inc., Kenilworth, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s 2016 Annual Report on Form 10-K and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).

Contacts

Merck
Media:
Pamela Eisele, 267-305-3558
or
Kate Prout, 267-305-1971
or
Investors:
Amy Klug, 908-740-1898

参考文章：

（1）In a stunner, Merck lands positive PhIII for its CETP outcast anacetrapib （作者：John Carroll）

（2）Merck Provides Update on REVEAL Outcomes Study of Anacetrapib （BusinessWire)

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