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諾華CEO:我們要重新定義拳頭產(chǎn)品

諾華CEO:我們要重新定義拳頭產(chǎn)品

Shelley DuBois 2013-03-07
大型醫(yī)藥公司一直將能夠收入數(shù)十億美元的藥品作為追逐目標(biāo),如今卻遇到了瓶頸。諾華公司CEO江慕忠為醫(yī)藥公司的拳頭產(chǎn)品樹立了一種新的典范。他們的研發(fā)對(duì)象不再直接針對(duì)適用人群龐大的疾病,而是轉(zhuǎn)向罕見(jiàn)病。這些領(lǐng)域不僅競(jìng)爭(zhēng)小,而且一旦取得突破,回報(bào)會(huì)非常豐厚。

????大型醫(yī)藥公司的規(guī)模依舊龐大,但商業(yè)模式卻開始走下坡路。多年以來(lái),制藥領(lǐng)域通常的做法都是研究、發(fā)現(xiàn),然后拼命守護(hù)能帶來(lái)數(shù)十億美元收入的藥物。

????然而,個(gè)別大型醫(yī)藥公司卻正在失去暢銷藥配方的專有權(quán)。輝瑞制藥(Pfizer)就是一個(gè)例子。它生產(chǎn)一種降膽固醇藥物立普妥。2012年,輝瑞失去了對(duì)這種藥物的專有權(quán),生產(chǎn)廉價(jià)非專利藥的公司將和它展開競(jìng)爭(zhēng)。

????這給公司帶來(lái)了嚴(yán)重影響。2012年第三季度收益報(bào)告中,公司CEO伊恩?里德解釋道:“年初至今,因失去專有權(quán)帶來(lái)的損失約為55億美元?!逼渲猩婕暗乃幬锇⑵胀缀推渌幬?。55億美元可不是個(gè)小數(shù)目。

????那么,制藥公司應(yīng)該如何避免這種情況發(fā)生呢?諾華公司CEO江慕忠向《財(cái)富》雜志(Fortune)建議的方法是,重新思考所謂的“拳頭產(chǎn)品”,或者每年至少能給公司帶來(lái)10億美元收入的藥物。江慕忠認(rèn)為:“對(duì)拳頭產(chǎn)品的定義正在發(fā)生變化?!?/p>

????傳統(tǒng)觀念認(rèn)為,“拳頭產(chǎn)品”所指的藥物能夠治療影響大量人口的疾病。由于拳頭產(chǎn)品利潤(rùn)非??捎^,因此各大公司都想盡可能地從中榨取利潤(rùn),導(dǎo)致公司減少了在新藥研發(fā)方面的支出。

????例如,大型醫(yī)藥公司通常會(huì)投資生產(chǎn)所謂的“仿制”藥物。公司生產(chǎn)這類產(chǎn)品所使用的基本配方與其拳頭產(chǎn)品完全相同,只是對(duì)其進(jìn)行稍微改動(dòng)和重新包裝,便作為一種新藥出售。江慕忠認(rèn)為,這種策略不可能長(zhǎng)久,因?yàn)椤镀絻r(jià)醫(yī)療法案》(Affordable Care Act)并不支持仿制藥物。之前,為了獲得美國(guó)食品和藥品管理局(FDA)的批準(zhǔn),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(jù)《平價(jià)醫(yī)療法案》,如果“新”藥物的藥效不能顯著好于已上市藥物,將無(wú)法獲得保險(xiǎn)公司的賠償。

????這意味著大型醫(yī)藥公司只有兩條路。一是努力保住對(duì)拳頭產(chǎn)品的專有權(quán)。輝瑞制藥在這方面有過(guò)成功的經(jīng)驗(yàn);輝瑞原本應(yīng)該在2012年就會(huì)失去偉哥(Viagra)產(chǎn)品的專利保護(hù)權(quán),但公司成功把專有權(quán)延長(zhǎng)到了2020年。

????但還有另外一個(gè)瘋狂的想法——研發(fā)新藥怎么樣?目前,醫(yī)藥領(lǐng)域的問(wèn)題是,在患者群體龐大的領(lǐng)域,如性功能障礙和心臟病領(lǐng)域,競(jìng)爭(zhēng)非常激烈。而江慕忠表示,諾華公司決定重新考慮藥物開發(fā)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.

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