諾華CEO：我們要重新定義拳頭產品

????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，制藥領域通常的做法都是研究、發現，然后拼命守護能帶來數十億美元收入的藥物。

????然而，個別大型醫藥公司卻正在失去暢銷藥配方的專有權。輝瑞制藥（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。

????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?里德解釋道：“年初至今，因失去專有權帶來的損失約為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。

????那么，制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》雜志（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。江慕忠認為：“對拳頭產品的定義正在發生變化。”

????傳統觀念認為，“拳頭產品”所指的藥物能夠治療影響大量人口的疾病。由于拳頭產品利潤非?？捎^，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。

????例如，大型醫藥公司通常會投資生產所謂的“仿制”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，便作為一種新藥出售。江慕忠認為，這種策略不可能長久，因為《平價醫療法案》（Affordable Care Act）并不支持仿制藥物。之前，為了獲得美國食品和藥品管理局（FDA）的批準，公司必須證明新藥物的藥效明顯好于安慰劑，但不需要證明該藥物的治療效果好于已上市的藥物。但根據《平價醫療法案》，如果“新”藥物的藥效不能顯著好于已上市藥物，將無法獲得保險公司的賠償。

????這意味著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。輝瑞制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。

????但還有另外一個瘋狂的想法——研發新藥怎么樣？目前，醫藥領域的問題是，在患者群體龐大的領域，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。

????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.

????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.

????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.

????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.

????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.

????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.

????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.

????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.