Nothing's more exciting than a head-to-head clinical trial between two drugs. It's one thing to put up a drug against a placebo, or even a group that got nothing, but when two established drugs are retested, mano a mano, to see which one is more effective, that's hot. Sales hinge on this stuff. Last year there were several of these in the stent-market, and the results were always surprising. In one case the winner had been misidentified until a late-inning press conference stated that Medtronic's forthcoming products could take on all comers. The reigning champ, Boston Scientific, left the event injured and still hasn't recovered.
This week there was another one for the statin market between Pfizer's Lipitor and Merck's Zocor, which is about to go generic. Since it'll be a lot cheaper once its status changes, Pfizer really need to land some knockout punches to demonstrate that it was worth paying a premium for Lipitor. It didn't. Here's Derek Lowe with the post-game commentary:
Pfizer's problem is that they missed their biggest target, a reduction in "major coronary events". The Lipitor and Zocor groups were indistinguishable. In some secondary categories, though, Lipitor came out ahead, such as when you look only at the frequency of nonfatal heart attacks. But overall cardiovascular mortality was the same for both groups. So Pfizer can claim some benefit from Lipitor, but not in the categories that would immediately convince cardiologists. I'm sure they'll be giving it the good ol' Groton try, though
All this is quite interesting, since Lipitor had already vanquished another statin, Pravachol, in a study in recent heart-attack survivors. Merck, meanwhile, had also tested Zocor in angioplasty patients, with disappointing results as compared to Lipitor's effects in a similar patient population. You can bet that Pfizer expected more from this study, and I'm still a bit puzzled that they didn't get it.
Analysts have already cut their sales estimates for Lipitor next year, figuring - surely correctly - that these results will cause some shift toward generic simvastatin. That doesn't do Merck much direct good, but it leaves them with an opening for their combination therapy Vytorin, which is Zocor plus Schering-Plough's cholestrol absorption inhibitor Zetia. And as fate would have it, they're running a big comparison of Vytorin to Zocor right now, since the darn stuff is going off patent, anyway.
As for Pfizer, the news couldn't get all that much worse. Here's an earlier entry from Derek Lowe, which simply spells out what's wrong with the company. All those have made them a bloated dinosaur. Maybe it looks good to acquire a small company with a hot drug in the short term, but in the long term, the drug dies down, and you're left with a bunch of redundant employees. This must be why the industry is in the rare practice of R&D layoffs. I thought pharmaceuticals were a growth industry.
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