诺华CEO：我们要重新定义拳头产品

    大型医药公司的规模依旧庞大，但商业模式却开始走下坡路。多年以来，制药领域通常的做法都是研究、发现，然后拼命守护能带来数十亿美元收入的药物。

    然而，个别大型医药公司却正在失去畅销药配方的专有权。辉瑞制药（Pfizer）就是一个例子。它生产一种降胆固醇药物立普妥。2012年，辉瑞失去了对这种药物的专有权，生产廉价非专利药的公司将和它展开竞争。

    这给公司带来了严重影响。2012年第三季度收益报告中，公司CEO伊恩•里德解释道：“年初至今，因失去专有权带来的损失约为55亿美元。”其中涉及的药物包括立普妥和其他药物。55亿美元可不是个小数目。

    那么，制药公司应该如何避免这种情况发生呢？诺华公司CEO江慕忠向《财富》杂志（Fortune）建议的方法是，重新思考所谓的“拳头产品”，或者每年至少能给公司带来10亿美元收入的药物。江慕忠认为：“对拳头产品的定义正在发生变化。”

    传统观念认为，“拳头产品”所指的药物能够治疗影响大量人口的疾病。由于拳头产品利润非常可观，因此各大公司都想尽可能地从中榨取利润，导致公司减少了在新药研发方面的支出。

    例如，大型医药公司通常会投资生产所谓的“仿制”药物。公司生产这类产品所使用的基本配方与其拳头产品完全相同，只是对其进行稍微改动和重新包装，便作为一种新药出售。江慕忠认为，这种策略不可能长久，因为《平价医疗法案》（Affordable Care Act）并不支持仿制药物。之前，为了获得美国食品和药品管理局（FDA）的批准，公司必须证明新药物的药效明显好于安慰剂，但不需要证明该药物的治疗效果好于已上市的药物。但根据《平价医疗法案》，如果“新”药物的药效不能显著好于已上市药物，将无法获得保险公司的赔偿。

    这意味着大型医药公司只有两条路。一是努力保住对拳头产品的专有权。辉瑞制药在这方面有过成功的经验；辉瑞原本应该在2012年就会失去伟哥（Viagra）产品的专利保护权，但公司成功把专有权延长到了2020年。

    但还有另外一个疯狂的想法——研发新药怎么样？目前，医药领域的问题是，在患者群体庞大的领域，如性功能障碍和心脏病领域，竞争非常激烈。而江慕忠表示，诺华公司决定重新考虑药物开发方案。

    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.