医药界-品牌药与仿制药之战(中英).doc

医药界：品牌药与仿制药之战
2006-8-30 15:55:0 | 发布:万晓文
面对仿制药的冲击，品牌药何去何从？2012年大部分畅销药专利到期，是实行价格战还是开发自己的替代的仿制药？经济学人的这篇文章讲述了医药界仿制药与品牌药的战争。

医药界：仿制药之战升级
万晓文译自2006年8月17日《经济学人》

大型医药公司从来就不喜欢加拿大。这个国家的社会医疗体系比起美国来利润相当薄弱，而来自加拿大"灰色市场"出口的品牌药物减少了他们肥沃的出口利润空间。但是，这些相比近几个月来自南方医药界新秀Apotex的打击来说就显得很微弱了。

法国的Sanofi-Aventis 与 Bristol-Myers Squibb (BMS)共同经营Plavix。Plavix是一种抑制血小板凝固的药物，可以防止心脏病发作，去年在全球销售额达到60亿美元，是世界上第二大销售量的药物。两家公司想在2012年 Plavix专利权到期前再榨取几十个亿的利润。

突然，令人震惊的是，Apotex在上个星期推出了一种新的普通替代药物，价格低于品牌Plavix。8月14日Sanofi and BMS申请法律文件禁止这种新药出口。一项听证会将在8月18日纽约举行。

这项新事业很大部分是Bernard Sherman大胆促成的，他是 Apotex聪明好斗的老板。迎着Sanofi公司的专利而上，他的公司一直在开发Plavix的仿制药。Apotex打赌Plavix的专利是非常易攻击的、公司不会被受禁止正如以前的很多专利案一样。最初，sanofi 与 BMS想跟Apotex谈判，大概是害怕Apotex的思路是正确的。他们想跟Sherman先生做一场交易，以使得他们在2011年不要推出仿制药，回报是丰富的财政以及保证不开发自己的仿制药来跟Apotex 竞争。工业专家Viren Mehta，称那个交易为"向Apotex的投降书——字字句句都是大让步"，但是这项交易被国家司法部长否决了，他排斥这项合同。联邦政府正在调查其中是否涉及经济犯罪。

Apotex对Plavix的攻击也许是最大的仿制药之战，但是其拥有仿制药前景良好的背景支撑。 IMS Health，一家顾问公司，评估说仿制药目前有600亿美元的市场份额。因为他们比那些品牌药物要便宜得多，尽管他们现在市场份额不高（仅占据了13％的世界药物市场），但是以量而计，在美国与英国都拿下了一半的市场份额。仿制药销售的增长率是两位数，两倍于市场总增长速度。

其中一个原因是政府控制保健成本支出，推动创造了需求，但是最重要的原因来自现在流行的药物"专利过期"。到2009年，35种畅销药品的12种将会失去专利保护。 Mehta评估说仅来自美国的仿制口冲击，由于未来五年很多医药失去专利保护的原因，而将导致28％的全球药物销售额约3070亿美元将会让位于仿制药。

为适应新形势，大型医药公司已经开始研制自己的仿制药。例如Merck公司已经与印度Reddy博士实验室合作开发降低胆固醇药物Zocor的仿制药。畅销药扩抑郁剂Pfizer也打算实施跟Zoloft一样的策略，通过它的Greenstone辅助开发仿制药。

还有一项新策略是价格策略。公司以前面对仿制品的竞争不会对他们的品牌药降价。现在，他们争先恐后地降价。例如 Merck在今年仿制药投放市场以前，将Zocor的价格压到如此低的层度以至于参议员Charles Schume指责公司掠夺性定价而要求进行调查"这是为了将仿制药排挤出市场以维持高价的铤而走险的做法"

Plavix的法律救济结果不明，但是其财务状况却是相当明显。这周报道说，Sanofi与BMS已经将Plavix的价格降至了Apotex的水平。正如 Mehta所说"这是项你死我亡的双败措施"

英文原文
Pharmaceuticals：Heartburn
Aug 17th 2006 | NEW YORK
From The Economist print edition

The battle over generic drugs heats up

BIG pharmaceuticals firms have never much liked Canada. The country's socialised medical system is less profitable for them than the American market, and "grey market" shipments of branded drugs from Canada have undercut the fat margins they are used to across the border. But those are minor irritants compared with the extraordinary blow delivered this month to two pharmaceutical giants by Apotex, a rising drugs star of the north.

France's Sanofi-Aventis and America's Bristol-Myers Squibb (BMS) jointly market Plavix, a drug that
inhibits blood platelets from sticking together to form clots, thus helping to prevent heart attacks and strokes. With global sales of nearly $6 billion last year, it is the world's second-biggest-selling drug. The firms had expected to squeeze out billions more dollars, since their patent on Plavix lasts until 2012.

Then, to everyone's shock, Apotex launched a generic version of the drug last week, undercutting the branded version's price. On August 14th Sanofi and BMS filed legal papers demanding a halt to the shipments. A hearing on the matter is due to begin in New York on August 18th.

A big part of the row is the audacity of Bernard Sherman, Apotex's clever and combative boss.
Undaunted by Sanofi's patents, his firm simply went ahead with a generic version of Plavix. Apotex is gambling that the Plavix patent is vulnerable and that it cannot be enforced—as has sometimes happened with previous patents. Earlier, Sanofi and BMS tried to negotiate, presumably fearing Apotex might be right. They struck a deal with Mr Sherman to delay the launch of his generic version until 2011 in return for a financial pay-off and the promise that the giants would not compete with Apotex by launching their own "authorised" generic. Viren Mehta, an industry expert, calls that deal a "capitulation to Apotex—every paragraph, every sentence is an outrageous series of concessions." But the deal fell foul of state attorneys-general, who scuppered the pact. Federal officials have now opened a criminal investigation.

Apotex's assault on Plavix may be the largest-ever generics launch, but it comes against a promising backdrop for generics. IMS Health, a consultancy, estimates that generic drugs are worth nearly $60 billion. Because they are much cheaper than branded drugs, their market share by value is small today (perhaps 13% of the global drugs market) but they already make up well over half of sales in America and Britain when measured by volume. Generic sales are growing at double-digit rates, twice as fast as the overall market.

One reason is a push by governments to contain health-care costs, which creates demand, but a bigger one is the coming wave of drugs going "off-patent". By 2009, 12 of the top 35 drugs today will lose their patent protection. Mr Mehta estimates that 28% of the global drugs industry's sales of $307 billion will be exposed to generic challenge in America alone, due to drugs going off-patent in the next five years.

In response, big pharmaceutical firms are starting to launch their own generic brands. Merck, for
instance, has joined hands with Dr Reddy's Laboratories, an Indian firm, to produce generic versions of its cholesterol-reducing drug, Zocor. Pfizer plans to do the same with Zoloft, its popular anti-depressant, through its Greenstone generics subsidiary.

Another new tactic is pricing. Firms used not to cut the price of their branded drugs much when faced with generic competition. Now, they are rushing to do so. Before the launch of a generic this year, Merck, for instance, slashed the price of Zocor to a level so low that Senator Charles Schumer accused the firm of predatory pricing, demanding an investigation: "It's a desperate move to keep prices high and generics out of the market," he said.

Plavix's legal prospects are unclear, but the financial picture is not. This week Sanofi and BMS were reported to be undercutting Apotex's generic with the price of branded Plavix. As Mr Mehta puts it, "this is a lose-lose proposition for them."