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Vytorin & therapeutic index


I Buzzed on this topic yesterday, but I wanted to expand slightly on it.

A statin is a drug that affects the lipid (fat) levels in the bloodstream. These drugs primarily lower LDL, or bad cholesterol. Statins are the world's best selling drugs, booking billions in annual sales for their manufacturers.

Zocor is the branded name of one statin. It's sold by Merck (MRK:NYSE)

Statins have serious side effects, especially at higher doses. As I noted previously, we have seen a string of changes that move the "safe" target LDL level lower and lower. One impact of these changes is the need to use statins in higher and higher doses to get LDL under proper control. This creates a problem in that to get a certain patient's LDL to target levels, statin dose levels are so high they get significant side effects from the drug.

Another way of lowering your LDL is by preventing your body from absorbing cholesterol from the foods you eat or re-absorbing it when LDL is created within your body. Zetia is a drug that does just this. Originally developed as an outright competitor for statins, it turns out it cannot match the LDL decreases of the statins so it would not be competitive on its own. Zetia has one benefit over statins, however, in that it has far fewer side effects.

Merck and Schering-Plough (SGP:NYSE) developed Zetia. Since Zocor is coming off patent in 2006 in the U.S. (and already off patent in parts of Europe), Merck needed a replacement anti-cholesterol product. Their solution was to combine Zetia and Zocor into one pill - Vytorin.

What the two companies are hoping for is to create a drug with a higher therapeutic index than the statins. In other words, they hope Vytorin does a better job of lowering LDL than a plain statin at similar statin dose levels. In this way, doctors can back off the dose of the side-effect-laden statins while still achieving target LDL levels. It's the best of both worlds - better (or equivalent) efficacy at lower side effects. A better therapeutic index.

The knock on Vytorin is that a doctor can do the same thing by prescribing Zetia plus a generic statin. Sure, the patient has to take two pills instead of one - but that's not a big deal for most patients despite what drug companies say and some on Wall Street believe.

I suspect much will depend on how Vytorin is priced in comparison to other statins. It is going to be a hard selling job for Merck and Schering's field sales people. And if you thought you couldn't turn around without seeing an ED drug (Viagra, etc.) advertisement, just wait until this new statin war really gets going.
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