TE||Making Merck work
1
导读
德国默克与美国默克
是同一家吗?
默克集团(Merck)成立于1668年,总部位于德国的Darmstadt,是国际著名的化学及制药公司。
1889年,乔治默克接管德国默克在美国纽约的分公司并创立美国默克,即默沙东。根据德国默克与默沙东(美国默克)协议,默沙东公司只可在北美地区使用“默克”之名。(美国默克不同德国默克:由于在美国出口业务的成功开展,默克公司于1887年在纽约成立了一个分公司。1889年,由HeinrichEmanuel Merck的孙子乔治默克接手经营。1891年,默克美国分公司Merck& Co。成立。第一次世界大战期间默克丧失了很多海外子公司,其中便包括Merck& Co.。如今这两家公司除了共同的名字“默克”之外,已经没有任何联系。应商业需要,双方一致同意,在美国和加拿大,“默克”归Merck & Co 独家使用,而在欧洲和世界其它各地,“默克”则由德国默克公司独家使用。与之相对应的,Merck & Co在北美之外的业务经营,须以MerckSharp & Dohme或 MSD Sharp &Dohme(默沙东)的名义进行。而默克股份两合公司在北美的业务则要以EMD (Emanuel Merck, Darmstadt首字母缩写)的名义开展。)
1953年美国默克与沙东公司(Sharpand Dohme)合并,正式成立默沙东药厂(Merck Sharp & Dohme,MSD),建立了一个具一体化的跨国药物生产及分发的实业。根据德国默克与默沙东(美国默克)协议,默沙东公司只可在北美地区(美国、加拿大)使用“默克”之名,在美国以外的地区必须使用默沙东的称呼。因此,默沙东公司(Merck& Co。)以Merck Sharp & Dohme品牌销售。
本段选自新浪财经:
http://finance.sina.com.cn/stock/usstock/c/20090309/23065951352.shtml
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Making Merck work
默克困境重生
本文英文部分选自经济学人Business版块
The pharma business
制药业务
Making Merck work
默克困境重生
A pharmaceutical firm bets big on a cancer drug
该医药公司在一个抗癌药物上下大赌注
But shareholders worry that Merck may be betting too heavily on cancer products such as Keytruda
但股东们担心默克在抗癌药物如Keytruda上的信心过大了
WHEN Ken Frazier, chief executive of Merck, an American pharmaceutical giant, started his job in 2011, he had a hard decision to make. The firm had promising new drugs—such as Januvia, for diabetes, and Gardasil, a vaccine against cervical cancer. But the pharma industry was struggling with dismal returns on R&D and investors were questioning if companies were overspending on science. Some surrendered and started buying in drugs instead. But Mr Frazier opted to carry on backing his labs and promised publicly to spend on R&D for the long term, not for the stockmarket’s immediate gratification.
当美国医药巨头默克的首席执行官Ken Frazier2011年开始工作时,他需要做一个艰难的决定。该公司曾经拥有具有发展潜力的新药---如用于防治糖尿病的西格列丁和用于防止宫颈癌的加德西疫苗。 但当时医药工业正在研发回报惨淡的泥淖中挣扎,投资者对企业在科研上的投资过重产生质疑。有些企业于是放弃了研发,转而开始收购药品。但Frazier先生选择支持他的实验室,并公开承诺将长期投资药品研发,而不会迎合股票市场的即时收益/(满足)。
An opportunity to implement the pledge soon arrived. Merck’s merger with another pharma firm, Schering-Plough, in 2009, had brought it an obscure new cancer drug. At first Merck’s scientists were unimpressed and relegated the drug to a list of assets to be licensed out. There was widespread scepticism at the time about whether drugs that attacked cancer using the immune system would work.
兑现承诺的机会很快就到了。2009年,默克收购另一家制药公司先灵葆雅,并带来了一种鲜为人知的新型抗癌药物。起初,默克公司的科学家们不以为然,并将这种药物列入到被批准出售的资产。当时人们普遍怀疑,利用免疫系统攻击癌症的药物是否有效。
注:1. https://www.bms.com/先灵葆雅是一家全球性的跨国制药公司,致力于研究开发,及推广新的疗法及治疗计划,以此改善人类的健康和拯救生命。
2.http://finance.sina.com.cn/money/usstock/merckshougou/默克收购先灵葆雅
Then the firm noticed that a rival, Bristol-Myers Squibb (BMS), was having success in trials of immuno-oncology drugs, and it fired the starting gun on the drug MK-3475, as it was then known. Using an innovative trial design, the firm pushed the drug through testing as quickly as possible. It won status as a breakthrough drug worthy of speedier approval from the regulator in 2013. By 2014 Keytruda (pembrolizumab) had reached the market to treat advanced melanoma, beating BMS’s rival drug, Opdivo (nivolumab), by months. It sold well, reaching $1bn in cumulative sales by the second quarter of 2016.
然后,该公司注意到,竞争对手百时美施贵宝(Bristol-Myers Squib)在免疫肿瘤学药物的试验中取得了成功,并且向当时为人所知的MK-3475药物进军。采用创新的试验设计,该公司尽快地推动药物通过测试。2013年,它作为一种突破性药物获得了监管机构的快速批准。到2014年,Keytruda (pembrolizumab)已经进入市场用于治疗晚期黑色素瘤,并在几个月内击败了BMS旗下的竞争产品,Opdivo (nivolumab)。该药物的销售表现很好,到2016年第二季度累计销售额达到10亿美元。
注:1. http://www.bms.com.cn/Pages/Home.aspx 百时美施贵宝公司是一家以科研为基础的全球性的从事医药保健及个人护理产品的多元化企业,其主要业务涵盖医药产品、日用消费品、营养品及医疗器械。
2. https://www.keytruda.com/
http://baike.sogou.com/v140358484.htm?fromTitle=Keytruda
Keytruda是阻断被称为PD-1的细胞通路的第一个被批准的药物,它限制机体免疫系统攻击黑色素瘤细胞的。
3. https://www.opdivo.com/
http://www.baike.com/wiki/Opdivo&prd=so_1_pic
Opdivo是一个人程序死亡受体-1(PD-1)适用为阻断抗体治疗有以下患者: ⑴有不能切除货转移黑色素瘤和易普利姆玛[ipilimumab]和,如BRAF V600突变阳性,一种BRAF抑制剂后疾病进展患者的治疗。 ⑵用基于铂化疗或后有进展的转移鳞状非小细胞肺癌。
The real commercial prize, however, was lung cancer, from which the industry makes a lot of money. Here Merck made another crucial decision, which was to use a “biomarker”, a way of choosing the patients most likely physically to respond well, which increases the likelihood of a successful trial outcome. The downside of the approach is that, once approved, a drug can only be given to patients who have that marker—which will crimp sales.
然而,真正的商业奖是肺癌,该产业从中赚了很多钱。默克公司做出了另一个关键性的决定,使用一种“生物标记物”,即选择最有可能身体反应良好的病人,从而增加成功试验结果的可能性。这种方法的不足之处在于,一旦获得批准,就只能给有这种标志物的病人服用药物-这会制约销售。
That problem became clear as Merck and BMS chased a series of approvals for their drugs to be used in lung cancers—initially as a second treatment choice and then as a primary treatment. The limitation resulting from Keytruda’s need to test for a biomarker helped Opdivo outsell it. But a turnaround came when Keytruda showed in mid-2016 that it was effective in trials that used it as a first treatment on a common type of lung cancer. Meanwhile, Opdivo, not using a biomarker and tested on a broader population of patients, failed (the lack of a biomarker made it harder to show that it improved survival rates).
当Merck和BMS为他们用于肺癌的一系列药物寻求批准时,这个问题就变得很清楚 - 最初是作为次要治疗手段,然后作为主要治疗手段。 Keytruda需要测试生物标志物的局限性使Opdivo销售超过了它。 但是,在2016年年中,Keytruda作为第一治疗手段运用于一种常见类型肺癌的试验中,并有效发挥了作用,成为转折点。 同时,没有使用生物标志物的Opdivo,在更广泛的患者群中进行上述肺癌测试时失败了。(缺乏生物标志物使得难以证明它提高了存活率)
In 2017 Keytruda’s sales almost tripled and surpassed $3.8bn. In the most recent quarter its sales nearly caught up with those of Opdivo. Merck’s fortunes now rely heavily on its wonder drug. Vamil Divan, an analyst at Credit Suisse, a bank, predicts that Keytruda sales will be about $10.7bn in 2030—not bad for a firm with annual revenues of $40bn. But the caveat is that this estimate lies in the middle of a whopping $4bn range of possible outcomes. The firm also does well in vaccines, making $6.5bn last year, and has a robust animal-health division. Yet sales of its cholesterol drugs, Zetia and Vytorin, have plunged thanks to competition from generics, while two lucrative diabetes medicines Januvia and Janumet, are likely to be threatened by newer medicines.
2017年Keytruda的销售额上涨了近三倍,超过了38亿美金。在最近的一个季度,其销售额几乎与Opdivo持平。如今,默克公司的财富大部分来源于这一神奇的药品。来自瑞信银行的分析师Vamil Divan预测Keytruda的销售额在2030年将达到107亿美金-对于一个年收益400亿美金的公司来说,这已经很不错了。该公司的疫苗销售业绩也不错,去年达到了65亿美金,并且还拥有一个实力雄厚的动物卫生科。然而,由于来自非专利药品的竞争,其胆固醇药品Zetia和Vytorin的销售额有所下滑。并且,其糖尿病药品Januvia和Janumet也有可能遭到新型药品的威胁。
Keytruda has new competition. Firms such as Roche and AstraZeneca are also rushing to deliver their own versions of immuno-oncology agents. Moreover Merck’s keen focus on oncology, and on one drug in particular, makes analysts worry that the firm is not sufficiently diversified. Yet it is pushing on regardless. Last year it agreed to pay AstraZeneca, a British pharma firm, up to $8.5bn to develop and commercialise its cancer drug Lynparza (olaparib), which seems likely to work well alongside Keytruda. It also acquired an immuno-oncology biotech firm, Rigontec, in September for $554m. The company says it is creating “a pipeline within a product”, arguing that it is diversified but in many different types of cancer.
Keytruda面临着新的竞争。同行的一些公司比如Roche和AstraZeneca也在加紧研发自己的免疫肿瘤药品。再者,默克公司非常热衷于肿瘤类药品,并且只专注于一种药品,这让分析师十分担忧其不够多元化。尽管如此,默克公司还是毫无顾虑地的一如前往。去年,默克公司与英国的一家制药公司AstraZeneca达成协议,将花费高达85亿美金合作研发并推广该公司的癌症药品Lynparza (olaparib),该药品与Keytruda同时服用,疗效更佳。同年9月,默克公司出资5.54亿美金收购了一家研究免疫肿瘤的生物科技公司Rigontec。默克公司声称,它是在搭建一个产品的内部生产线,并认为他们关注不同种类的癌症,已经走向多元化。
Merck’s confidence recalls the period when it was one of the most admired firms in America; the Apple or the Amazon of its day. Its innovation in cholesterol-lowering drugs and HIV medicines in the 1990s gave it a reputation as a company that made society, as well as people, better.
默克的信心让人想起它曾经是美国最令人赞叹的公司之一;就如同今天的亚马逊或者苹果。90年代,默克在降低类固醇水平和艾滋病(治疗)药物方面的创新让整个社会和人民都变得更好。
After the millennium it took a series of blows. In addition to patent expiries came the news that its drug Vioxx, used to treat osteoarthritis, also increased the risk of cardiovascular disease. These left it risk-averse for years. But under Mr Frazier, Merck appears to have regained its focus. Fighting cancer makes historic sense. Rising cancer rates, after all, are partly the result of lifespans extended by its earlier generations of blockbuster drugs.
千禧年后,它经历了一系列打击。除了专利过期以外,默克旗下的骨关节炎治疗药物-万络会增加心血管疾病的风险也上了新闻。以上这些都使得默克不愿意冒风险了。但是在肯尼斯·弗雷泽的领导下,默克似乎重新找到了方向。抗癌,重回历史的方向。不断增加的癌症爆发率有部分是由于上一代出彩的药物提高了人类寿命导致的。
注:Vioxx-万络,亦称作罗非昔布,是一种非甾体抗炎药,现已被撤销安全警告。由默克公司推广的治疗关节炎的药物。
https://en.m.wikipedia.org/wiki/Rofecoxib
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从销售额上来看,默沙东的销售从10亿美元,到如今的38亿美元,数额巨大。但做医药行业的人都知道,一个新药研发的费用也是大的惊人的。文章中没有写明,20年前一个新药研发的费用已经达到了近8亿美金,耗时上十年时间。而且这么大量的投入还不一定能保证一个新药的确定能上市,以及上市后的生命周期有多长。因此我对抗癌药物的昂贵表示理解,虽然对癌症患者更是深表同情。但是如果不给抗癌药物公司以足够的回报,没有企业愿意再投入去做新药研发,对人类来说也是灾难。
医药的研发治病救人,如果能够作为政府投入项目,那么对默克这样的企业或者对普通消费者都应该是好事。医药公司在研发上压力减小,会更愿意投入,普通民众需要用药时也能不那么昂贵的获得延续生命的机会。而政府那么大量的税收,反馈到医药,也算是个利国利民。
Frazier先生可谓大智。同时也能看到竞争对手的动作对默克的影响。作为普通人,庆幸有默克这样的公司愿意花大价钱研发救命药,也庆幸有默克有施贵宝之类的竞争对手,使得这些药物不那么昂贵。
考验一个药物市场能力最重要还是药效,生物标记法的发明对默克公司来说受益良多。一个效果良好,生命周期长的药品研发出来,就好似对普通人来说买彩票中了五百万。文中担忧默克过于倚重默沙东,我却认为这并不算是坏事,毕竟要研发出另一个默沙东并不是那么容易的事情。而为了应对这种单品倚重各处收购的行为,只不过玩的仍旧是类似于那个欧洲神秘富贵家族的资金游戏而已,已经与产品研发无关。
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