諾華CEO:我們要重新定義拳頭產品

Big Pharma is still big, but its business model is dying. For years, the game in pharmaceuticals has been to research, discover and then fiercely defend billion-dollar drugs.

大型醫藥公司的規模依舊龐大，但商業模式卻開始走下坡路。多年以來，製藥領域通常的做法都是研究、發現，然後拼命守護能帶來數十億美元收入的藥物。

But several mighty drug companies are losing the rights to exclusively own the formulas for best-selling drugs. Take Pfizer (PFE), which made a killing off cholesterol medication Lipitor. In 2012, Pfizer lost the exclusive rights to the drug, opening it up to competition from companies that produce cheaper, generic versions.

然而，個別大型醫藥公司卻正在失去暢銷藥配方的專有權。輝瑞製藥（Pfizer）就是一個例子。它生產一種降膽固醇藥物立普妥。2012年，輝瑞失去了對這種藥物的專有權，生產廉價非專利藥的公司將和它展開競爭。

That hurt. CEO Ian Read explained in the 2012 third-quarter earnings report, "Year-to-date we have absorbed approximately $5.5 billion in LOEs." An "LOE" is a loss of exclusivity to drug formulas, including Lipitor and others in this case, and $5.5 billion is no joke.

這給公司帶來了嚴重影響。2012年第三季度收益報告中，公司CEO伊恩?裏德解釋道：“年初至今，因失去專有權帶來的損失約爲55億美元。”其中涉及的藥物包括立普妥和其他藥物。55億美元可不是個小數目。

So how can drug companies prevent these kinds of losses? One way, Novartis CEO Joseph Jimenez suggested to Fortune, is to re-imagine what is known as a blockbuster, or a drug that earns the company at least $1 billion per-year. "The definition of a blockbuster is changing," Jimenez said.

那麼，製藥公司應該如何避免這種情況發生呢？諾華公司CEO江慕忠向《財富》雜誌（Fortune）建議的方法是，重新思考所謂的“拳頭產品”，或者每年至少能給公司帶來10億美元收入的藥物。江慕忠認爲：“對拳頭產品的定義正在發生變化。”

The old concept of a blockbuster has generally been one drug to treat one disease that affects a large population. Because blockbusters are so profitable, companies scramble to squeeze as much money out of them as possible, arguably in a way that detracts from efforts to research and develop novel treatments.

傳統觀念認爲，“拳頭產品”所指的藥物能夠治療影響大量人口的疾病。由於拳頭產品利潤非常可觀，因此各大公司都想盡可能地從中榨取利潤，導致公司減少了在新藥研發方面的支出。

For example, large pharmaceutical companies have invested in what's known as "me-too" drugs. Companies make drugs with the same basic formulas as some of their bestsellers, tweak them slightly, and re-package them as new treatments. That strategy won't work for much longer, says Jimenez, given that the Affordable Care Act will discourage me-too drugs. Previously, to get FDA approval, companies had to prove that new drugs performed significantly better than a placebo, but they didn't have to show that the treatment performed better than drugs already on the market. Under the ACA, "new" drugs that don't perform significantly better than current options won't be eligible for reimbursement from insurance companies.

例如，大型醫藥公司通常會投資生產所謂的“仿製”藥物。公司生產這類產品所使用的基本配方與其拳頭產品完全相同，只是對其進行稍微改動和重新包裝，便作爲一種新藥出售。江慕忠認爲，這種策略不可能長久，因爲《平價醫療法案》（Affordable Care Act）並不支持仿製藥物。之前，爲了獲得美國食品和藥品管理局（FDA）的批准，公司必須證明新藥物的藥效明顯好於安慰劑，但不需要證明該藥物的治療效果好於已上市的藥物。但根據《平價醫療法案》，如果“新”藥物的藥效不能顯著好於已上市藥物，將無法獲得保險公司的賠償。

This means Big Pharma has a couple of options. For one, they can fight to keep the rights to blockbusters. Pfizer has had some success with this; its hugely profitable drug Viagra was supposed to go off patent in 2012, but the company managed to extend its exclusivity rights until 2020.

這意味着大型醫藥公司只有兩條路。一是努力保住對拳頭產品的專有權。輝瑞製藥在這方面有過成功的經驗；輝瑞原本應該在2012年就會失去偉哥（Viagra）產品的專利保護權，但公司成功把專有權延長到了2020年。

But here's a crazy idea -- what about making new drugs? The catch is that competition is fierce in areas with big patient populations such as erectile dysfunction and heart disease. But Novartis has decided re-think the methodology behind drug development, Jimenez says.

但還有另外一個瘋狂的想法——研發新藥怎麼樣？目前，醫藥領域的問題是，在患者羣體龐大的領域，如性功能障礙和心臟病領域，競爭非常激烈。而江慕忠表示，諾華公司決定重新考慮藥物開發方案。

It takes into account the fact that, in general, effective research and development doesn't come from targeting the most profitable problems. Basic research often takes many twists and turns. The discovery of Penicillin, famously, was a happy accident. Novartis (NVS) has a new strategy to try to generate that kind of serendipity. Instead of targeting a disease with a massive patient population, the company is instead targeting pathways, or the distinct biological mechanisms that cause a disease.

公司考慮到這樣一個事實，即最成功的研發起初並不是直接針對盈利前景最好的醫療問題。基礎研究通常會經歷種種波折。盤尼西林便是最有名的例子，它的發現完全是一個意外之喜。諾華公司新策略的目的就是找到這種意外的驚喜。公司並不是把患者羣體龐大的疾病作爲目標，而是將藥品開發途徑或導致疾病的不同生物機制作爲重點。

The company has seen some success with this method. It developed its drug Afinitor, for example, for with the idea to target a cluster of diseases. Afinitor was first approved to treat kidney cancer. But research demonstrated that it also works in patients with some lung and breast cancers. Sales of Afinitor for breast cancer do not add up to $1 billion, neither do sales of Afinitor as a kidney cancer or lung cancer treatment. But looking at the sales numbers combined, it makes a blockbuster.

這種方法已經取得了一定的成功。例如，公司針對一系列疾病研發的藥物依維莫司（Afinitor）最初被批准用於腎癌治療。但研究證明，這種藥物對於治療肺癌與乳腺癌同樣有效。將依維莫司作爲治療乳腺癌的藥物，它的銷量達不到10億美元，而作爲治療腎癌或肺癌的藥物，它的銷量同樣達不到10億美元。但如果將三者綜合起來，依維莫司便可以成爲諾華公司新的拳頭產品。

There are pros and cons to this method. According to a February analyst report from Morningstar, Novartis is well positioned for good long-term growth. But investors need to understand that this kind of growth can take time. The old blockbuster-finding strategy hasn't been sustainable, but it's been profitable immediately. Novartis is taking a different route through drugs that treat smaller patient populations.

當然這種方法有利有弊。晨星公司（Morningstar）二月份的分析師報告顯示，諾華公司具備長期良性發展的條件。但投資者必須理解，這種增長需要時間。傳統的尋找拳頭產品的策略雖然不能持久，但卻能迅速產生利潤。而諾華公司致力於針對患者人羣較小的藥物，走了一條截然不同的道路。

Investors aren't always willing to be patient. For example, in 2009, Novartis received approval for Ilaris, a drug that treats CAPS, a class of rare, potentially fatal autoinflammatory diseases that can cause fevers and chills, bone deformities, and loss of vision. "Many of our people said, 'Why are you designing a drug for only 6,000 people in the world; CAPS is so rare?'" No one else was making drugs to treat the disease.

投資者往往都缺乏耐心。例如，2009年，諾華研發的藥物Ilaris獲批用於冷吡啉相關週期性綜合症（CAPS）的治療。CAPS是一種罕見的、可能致命的自體發炎性疾病，可能導致發熱、發冷、骨畸形和失明。“公司許多人都說：‘你們爲什麼生產這樣一款藥物？全球只有6,000人患有這種疾病；CAPS太罕見了。’”沒有其他任何一家公司在生產治療這種疾病的藥物。

But the idea is that cracking the code to treat CAPS will lead the way to treatment of other diseases caused by the same mechanism.

而諾華公司的觀點是，在CAPS治療中的突破可以爲由相同機制引發的其他疾病的治療提供思路。

Using this strategy, Novartis will not bet the farm on finding the next massive breakthrough, such as an Alzheimer's drug, which is a tack its competitors have taken.

通過這種策略，諾華公司不再將賭注壓在尋找下一個巨大的突破上，例如其他競爭對手正在關注的阿爾茨海默病（俗稱老年癡呆症）藥物。

But there are clear pros to the company's plan. For one, Novartis will make treatments for rare diseases that could ultimately blossom into blockbusters by virtue of their application to multiple maladies. Even the drugs that don't materialize into great sales numbers will get the company into a new market.

公司的計劃有非常明顯的優勢。比如，諾華公司生產治療罕見疾病的藥物，通過藥物在不同疾病中的療效，最終可能成爲公司的拳頭產品。即使藥物無法取得龐大的銷量，但仍可以爲公司打開新的市場。

And to chuck the business angle for a moment, the big-picture pro of this strategy is that it means Novartis will be making medicine for people who need it, despite the industry straying from that somewhat as an effective business strategy.

暫且拋開商業角度不談，這種策略的一個巨大優勢在於，它意味着諾華公司將爲有需要的患者生產藥物，這纔是醫藥公司行之有效的商業策略，儘管整個醫藥行業正在偏離這一軌道。

Making drugs, after all, is what drug companies are supposed to do.

畢竟，生產藥品纔是製藥公司的本分。