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DBL%20Hendrix%20small.png College chemistry, 1983

Derek Lowe The 2002 Model

Dbl%20new%20portrait%20B%26W.png After 10 years of blogging. . .

Derek Lowe, an Arkansan by birth, got his BA from Hendrix College and his PhD in organic chemistry from Duke before spending time in Germany on a Humboldt Fellowship on his post-doc. He's worked for several major pharmaceutical companies since 1989 on drug discovery projects against schizophrenia, Alzheimer's, diabetes, osteoporosis and other diseases. To contact Derek email him directly: derekb.lowe@gmail.com Twitter: Dereklowe

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In the Pipeline

« Clinical Trials And What to Do With Them | Main | Around and About »

August 31, 2004

Me Too, Part Two

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Posted by Derek

As came up in the comments to the previous post, there's not as much price competition inside a given drug category as you'd think. That's not because we're Evil Price Gougers, at least not necessarily. As I was pointed out yesterday, "me-too" type drugs aren't as equivalent as some people think. The main reason we go ahead with a drug in a category where there's already competition is because we think we have some advantage that we can use to gain market share.

This is a constant worry in every drug development effort where there's already a compound out there. I've personally, many times, been in drug project meetings where we've looked at the best competing compound (one that's either already marketed or well into clinical trials) and said "We haven't beaten them yet. We're not going to make it without some kind of unique selling point." The best of those, naturally, would be superior efficacy or a superior safety profile. Then you have easier dosing, fewer interactions with other drugs, and so on. I need to emphasize this: I have seen drug projects killed because no case for an advantage could be made.

Now, there's room to argue about how much better efficacy a drug needs to be a real advance in the field, or at least a bigger seller. You can argue about any of those possible advantages I listed, and it's true that drug companies push some compounds that aren't exactly huge leaps over the previous state of the art. (You see more of that when there's a case of shriveled pipeline in progress.) But there has to be something, and the bigger the difference, the better it is for us. We're motivated, by market forces, to come up with the biggest advances we can. The sales force would much, much rather be out there with data to show that the new drug beats the competition in a clean fight, as opposed to saying that it beats the old one on points, in a subset of patients, if you massage the data enough and squint hard, and besides it tastes better, too. . .

And as I've pointed out before, we often find out things about compounds long after they've reached the market. Lipitor, as discussed yesterday, is a case in point. I have not been a Lipitor fan in the past. The statin field seemed already pretty well served to me (as it did to a number of people inside Warner-Lambert during the drug's development, frankly.) The drug made its way forward based on efficacy in the clinic: it seemed to do a better job lowering cholesterol and improving the LDL/HDL ratio. How much advantage that is in the long term is another question, but those are the best markers we have.

The whole antiinflammatory c-reactive-protein story about the drug only came up after it was already on the market. The marked differences between it and the other statins, which I have to assume at this point are real, are a pleasant surprise to everyone involved. Warner-Lambert (and then Pfizer) thought it was a better compound, but not to this degree or for these reasons, I'l bet. I'd say that this is another argument for having multiple drugs in the same category. We don't, and can't, know everything that they'll do.

Comments (2) + TrackBacks (0) | Category: "Me Too" Drugs | Cardiovascular Disease | Clinical Trials | Drug Development | Drug Prices


COMMENTS

1. John Johnson on September 1, 2004 10:09 AM writes...

I think the most important argument for having multiple drugs in the same category is that people and their bodies do the darndest things. Some people may not respond to Zocor but may respond beautifully to Lipitor. Or they may experience less muscle weakness under Crestor.

Clinical trials attempt to control outside influences as well as necessary. Clinical practice is much different, and the focus is different. The analysis of clinical trials focuses on populations and subpopulations, while clinical practice focuses on individuals. The fact of the matter is that data from clinical trials only suggest trends, and when we apply this knowledge to an individual, the best we can do is hope the trend holds up. But the rate of metabolism and other factors mitigate the response (desired and otherwise), and having many choices is better than saying, "Well, you have a choice: high cholesterol or muscle weakness."

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2. jeet on September 1, 2004 5:06 PM writes...

not to mention price competition. multiple drugs in the same category allow insurance companies to bargin with manufacturers to get a better deal. the drug with the better pricing gets the more favorable tiering status.

drugs with no effective competition have very strong pricing power. recently medicare enacted some very deep price cuts in certain single source drugs (see epogen) due to the realization that there is no other way to constrain price. granted these cuts were in response to the difference in price between the open market and what medicare usually pays, but the magnitude of the cuts gives medicare favorable pricing compared to private insurance in these instances.

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