但是正如葛兰素史克和波赞（GSK/Pozen）公司今天所遇到的情况，这种所谓的复方药物开发的光明道路充满了陷阱。美国FDA再次重申，暂时不会批准复方药物Trexima，这种药物由葛兰素公司治疗偏头痛的重磅药物舒马普坦与非专利止痛药萘普生（商品名为Aleve）组合而成。葛兰素史克公司声明，早期实验研究表明复方药物比起单一药物增加了更多未经报道过的安全隐患，而FDA需要得到有关这方面更多的信息。
这种药物批准的延迟，对这两个公司都是一种巨大的打击。葛兰素迫切希望该药物能够尽快得到批准，以便能在2009年前让患者改用Trexima，因为那时舒马普坦的专利因到期而面临仿制药的竞争。波赞公司至今还没有上市品种，Trexima药物是它最具有开发潜力的药物。当天早晨波赞公司的股票就由于这个延迟消息而下跌了45%以上。甚至可以说，即使这个复方药得到批准后也并不意味着有绝对的赢家。就在昨天，我们写了一篇关于NitroMed公司正在努力增加复方药物BiDil的销售，该药物由两种非专利药物组合而成。而辉瑞公司经过多年的经营开发，也没有从Caduet这种复合药物中得到太多的利益，该药物由立普妥（Lipitor）和络活喜（Norvasc）组合而成。在今年第二季度，已经登记注册的复方药物全世界的销量仅为一亿一千九百万美金。
当然也有诸多原因促使许多公司乐忠于开发此类复方药物。默克公司和先灵葆雅公司将通过复方药物Vytorin得到巨额的销售收入，该复方药物由两种胆固醇药物组成，一种为专利药，一种为非专利药。该药物服用方便，特别对于诸如艾滋病这类疾病，复方药物能够简化多种药物的服用，如果推荐服用的话，患者更加愿意接受。
Combo Pills Prove Alluring but Tricky
Posted by Jacob Goldstein
Hey, everybody, I’ve got an idea for a fast and easy way to rejuvenate revenues without actually coming up with a new drug: Let’s make a combo pill! We’ll just take a couple old drugs off the shelf, mix them up in a single pill, and patent it. Instant blockbuster,right?
It turns out the golden road to combo-pill riches is full of potholes– as GlaxoSmithKline and Pozen learned today. The FDA for the second time said it wasn’t ready to approve Trexima, a pill that combines Glaxo’s migraine blockbuster Imitrex with the generic painkiller naproxen (sold under the brand name Aleve). The agency wants more information from an early lab study that suggested the combination could carry risks not posed by either drug alone, Glaxo said.
The delay is a tough blow for both companies. Glaxo is eager to get the drug approved, so it can switch patients to Trexima well before 2009, when Imitrex will face generic competition. Pozen doesn’t have any drugs on the market, and Trexima is its lead horse. The company’s stock plunged more than 45% this morning on the delay.
Even combos that get approved aren’t surefire winners. Just yesterday, we wrote about NitroMed’s struggle to boost sales for BiDil, a heart pill that combines two generic medicines. And Pfizer hasn’t gotten much traction with Caduet, a combination of Lipitor and Norvasc, despite years of trying. In the second quarter, the combo cardio pill registered sales of just $119 million world-wide.
Of course, there are reasons for companies to keep trying with combo pills. Merck and Schering-Plough have recently seen strong sales of Vytorin, a combination of two cholesterol medicines (one branded, one generic). And the drugs can be more convenient, especially in diseases like AIDS, where combination pills can simplify complicated multi-drug regimens and may make it more likely patients will take their medicine when they’re supposed to.
