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Making Merck work

默克困境重生

本文英文部分選自經(jīng)濟學(xué)人Business版塊

The pharma business

制藥業(yè)務(wù)

Making Merck work

默克困境重生

A pharmaceutical firm bets big on a cancer drug

該醫(yī)藥公司在一個抗癌藥物上下大賭注

But shareholders worry that Merck may be betting too heavily on cancer products such as Keytruda

但股東們擔心默克在抗癌藥物如Keytruda上的信心過大了

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.

當美國醫(yī)藥巨頭默克的首席執(zhí)行官Ken Frazier2011年開始工作時,，他需要做一個艱難的決定。該公司曾經(jīng)擁有具有發(fā)展?jié)摿Φ男滤?span style="font-size: 14px;text-decoration: none;">---如用于防治糖尿病的西格列丁和用于防止宮頸癌的加德西疫苗,。 但當時醫(yī)藥工業(yè)正在研發(fā)回報慘淡的泥淖中掙扎,，投資者對企業(yè)在科研上的投資過重產(chǎn)生質(zhì)疑。有些企業(yè)于是放棄了研發(fā),，轉(zhuǎn)而開始收購藥品,。但Frazier先生選擇支持他的實驗室，并公開承諾將長期投資藥品研發(fā),，而不會迎合股票市場的即時收益/（滿足）,。

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.

兌現(xiàn)承諾的機會很快就到了。2009年,，默克收購另一家制藥公司先靈葆雅,，并帶來了一種鮮為人知的新型抗癌藥物。起初,，默克公司的科學(xué)家們不以為然,，并將這種藥物列入到被批準出售的資產(chǎn)。當時人們普遍懷疑，利用免疫系統(tǒng)攻擊癌癥的藥物是否有效,。

注：1. https://www./先靈葆雅是一家全球性的跨國制藥公司,，致力于研究開發(fā)，及推廣新的療法及治療計劃,，以此改善人類的健康和拯救生命,。

2.http://finance.sina.com.cn/money/usstock/merckshougou/默克收購先靈葆雅

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，該公司注意到,，競爭對手百時美施貴寶（Bristol-Myers Squib）在免疫腫瘤學(xué)藥物的試驗中取得了成功,，并且向當時為人所知的MK-3475藥物進軍。采用創(chuàng)新的試驗設(shè)計,，該公司盡快地推動藥物通過測試,。2013年，它作為一種突破性藥物獲得了監(jiān)管機構(gòu)的快速批準,。到2014年,，Keytruda (pembrolizumab)已經(jīng)進入市場用于治療晚期黑色素瘤，并在幾個月內(nèi)擊敗了BMS旗下的競爭產(chǎn)品,，Opdivo (nivolumab),。該藥物的銷售表現(xiàn)很好，到2016年第二季度累計銷售額達到10億美元,。

注：1. http://www..cn/Pages/Home.aspx 百時美施貴寶公司是一家以科研為基礎(chǔ)的全球性的從事醫(yī)藥保健及個人護理產(chǎn)品的多元化企業(yè),，其主要業(yè)務(wù)涵蓋醫(yī)藥產(chǎn)品、日用消費品,、營養(yǎng)品及醫(yī)療器械,。

2. https://www./

http://baike.sogou.com/v140358484.htm?fromTitle=Keytruda

Keytruda是阻斷被稱為PD-1的細胞通路的第一個被批準的藥物，它限制機體免疫系統(tǒng)攻擊黑色素瘤細胞的,。

3. https://www./

http://www.baike.com/wiki/Opdivo&prd=so_1_pic

Opdivo是一個人程序死亡受體-1（PD-1）適用為阻斷抗體治療有以下患者： ⑴有不能切除貨轉(zhuǎn)移黑色素瘤和易普利姆瑪[ipilimumab]和,，如BRAF V600突變陽性，一種BRAF抑制劑后疾病進展患者的治療,。 ⑵用基于鉑化療或后有進展的轉(zhuǎn)移鱗狀非小細胞肺癌。

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,，真正的商業(yè)獎是肺癌,，該產(chǎn)業(yè)從中賺了很多錢。默克公司做出了另一個關(guān)鍵性的決定,，使用一種“生物標記物”,，即選擇最有可能身體反應(yīng)良好的病人，從而增加成功試驗結(jié)果的可能性,。這種方法的不足之處在于,，一旦獲得批準，就只能給有這種標志物的病人服用藥物-這會制約銷售。

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).

當Merck和BMS為他們用于肺癌的一系列藥物尋求批準時,，這個問題就變得很清楚 - 最初是作為次要治療手段,，然后作為主要治療手段。 Keytruda需要測試生物標志物的局限性使Opdivo銷售超過了它,。 但是,，在2016年年中，Keytruda作為第一治療手段運用于一種常見類型肺癌的試驗中,，并有效發(fā)揮了作用,，成為轉(zhuǎn)折點。 同時,，沒有使用生物標志物的Opdivo,，在更廣泛的患者群中進行上述肺癌測試時失敗了。（缺乏生物標志物使得難以證明它提高了存活率）

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的銷售額上漲了近三倍,，超過了38億美金,。在最近的一個季度，其銷售額幾乎與Opdivo持平,。如今,，默克公司的財富大部分來源于這一神奇的藥品。來自瑞信銀行的分析師Vamil Divan預(yù)測Keytruda的銷售額在2030年將達到107億美金-對于一個年收益400億美金的公司來說,，這已經(jīng)很不錯了,。該公司的疫苗銷售業(yè)績也不錯，去年達到了65億美金,，并且還擁有一個實力雄厚的動物衛(wèi)生科,。然而，由于來自非專利藥品的競爭,，其膽固醇藥品Zetia和Vytorin的銷售額有所下滑,。并且，其糖尿病藥品Januvia和Janumet也有可能遭到新型藥品的威脅,。

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面臨著新的競爭,。同行的一些公司比如Roche和AstraZeneca也在加緊研發(fā)自己的免疫腫瘤藥品。再者,，默克公司非常熱衷于腫瘤類藥品,，并且只專注于一種藥品，這讓分析師十分擔憂其不夠多元化,。盡管如此,，默克公司還是毫無顧慮地的一如前往。去年,，默克公司與英國的一家制藥公司AstraZeneca達成協(xié)議,，將花費高達85億美金合作研發(fā)并推廣該公司的癌癥藥品Lynparza (olaparib)，該藥品與Keytruda同時服用，療效更佳,。同年9月,，默克公司出資5.54億美金收購了一家研究免疫腫瘤的生物科技公司Rigontec。默克公司聲稱,，它是在搭建一個產(chǎn)品的內(nèi)部生產(chǎn)線,，并認為他們關(guān)注不同種類的癌癥，已經(jīng)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.

默克的信心讓人想起它曾經(jīng)是美國最令人贊嘆的公司之一,；就如同今天的亞馬遜或者蘋果。90年代,，默克在降低類固醇水平和艾滋?。ㄖ委煟┧幬锓矫娴膭?chuàng)新讓整個社會和人民都變得更好。

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,，它經(jīng)歷了一系列打擊,。除了專利過期以外，默克旗下的骨關(guān)節(jié)炎治療藥物-萬絡(luò)會增加心血管疾病的風(fēng)險也上了新聞,。以上這些都使得默克不愿意冒風(fēng)險了,。但是在肯尼斯·弗雷澤的領(lǐng)導(dǎo)下，默克似乎重新找到了方向,?？拱鼗貧v史的方向,。不斷增加的癌癥爆發(fā)率有部分是由于上一代出彩的藥物提高了人類壽命導(dǎo)致的,。

注：Vioxx-萬絡(luò)，亦稱作羅非昔布,，是一種非甾體抗炎藥,，現(xiàn)已被撤銷安全警告。由默克公司推廣的治療關(guān)節(jié)炎的藥物,。

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