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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

« The New England Journal of Legal Immunity? | Main | Attack of the Angry Viruses »

December 14, 2005

An Expensive Way Back for Celebrex

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Posted by Derek

Pfizer's going to pull out the stops and spend up to $100 million to try to show that their COX-2 drug Celebrex is worth it. And they're going right to the source: the Cleveland Clinic. The study will be run by Steve Nissen, and he's forbidding the investigators under him from accepting money from all sides: drug companies, securities firms, trial lawyers, the lot. Celebrex will be compared head-to-head in high-cardiac-risk arthritis patients versus naproxen and ibuprofen (no aspirin, because of the near-certainly of bleeding problems at the doses involved).

A disproportionate number of arthritis sufferers are in the higher-risk groups, so this would seem to be an appropriate patient population. They're going to need to round up 20,000 of them, though, which is going to take some time, and the whole study won't finish up until 2009, at the current best guess. (Celebrex doesn't come off patent until 2013, in case you're wondering). I hammer on Pfizer a lot around here, because I think they're too big to be effective as a company. But I have to say that this is one case where being humungous (and, for now, full of cash) is an asset. This is going to be a long a costly trial, and you can count the drug companies capable of funding it on one hand.

Merck's taking a few shots in the press today, since they'd said that a study like this basically couldn't be run. No one would do it unless they felt they had to, that's for sure. But the loss of Vioxx as a competitor may have made this study possible for Pfizer, in that it could allow them to earn back the expense more easily. Celebrex first has to show that it doesn't have the cardiac risks associated with Vioxx (which are tiny, but real). If it doesn't do that, it's dead. But if it makes it past that, and actually works better than the cheaper alternatives, Pfizer will own the market. They'd at worst dominate it over some other COX-2 stragglers like Novartis's Prexige, which I don't think has even been filed for US approval yet. Novartis is on that short list of companies that can afford this kind of clinical expense for a single trial, and they may have to consider doing a big head-to-head with Celebrex if they want to stay in the market. Smaller studies aren't going to cut it in the COX-2 area any more.

Comments (17) + TrackBacks (0) | Category: Cardiovascular Disease | Clinical Trials


COMMENTS

1. SP on December 14, 2005 11:54 PM writes...

If, and it's a big if, they have very good reason to believe the trial will turn out in their favor, then the investment is a no brainer. Exclusive control of that market for three to four years is several billion dollars of sales. I'd love to make a 50 fold return on all my money.

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2. Joel Sax on December 15, 2005 2:39 AM writes...

Will they be releasing a Cereblex for those of us who have bipolar and don't want any more fun in our lives? :)

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3. NJBiologist on December 15, 2005 8:14 AM writes...

Anyone want to guess how long it will be before the conspiracy theorists try to link this to Dr. Topol's demotion?

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4. burt on December 15, 2005 8:46 AM writes...

I am aware of internal Celebrex results prior to FDA approval. The study will almost certainly be a success. Celebrex is a pretty clean drug. Addirionally, Vioxx is a FAIRLY clean drug, and, I believe, will return to market in a few years. I would state further: there is no convincing evidence that there is anything wrong with selective COX-2 inhibitors as a class. Some compounds, like Vioxx, cause mild edema. If you prescribe knowing the *slight* risks, the cost/benfit ratio is good.

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5. Derek Lowe on December 15, 2005 9:41 AM writes...

That's the big If, SP. Of course, if they knew that well enough not to be worried, they might not have to run the trial in the first place. There have been plenty of jack-in-the-box results from these big studies.

Pfizer probably feels that they have no choice, though. Celebrex is always going to be under a cloud, with diminished sales, unless the cardiovascular risk question can be answered. And there's the "is this really better than something I can get OTC" question, which they're taking on, too.

It's true that Celebrex sales will rapidly make up the cost if things work out. But not too many other drugs could support having an extra four-year hundred-million-dollar clinical trial piled on them. . .

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6. John Johnson on December 15, 2005 10:00 AM writes...

Most drug companies I know pull their hair out over a hundred grand. Granted, that fact alone keeps my job as a statistician interesting (coming up with ways of squeezing the same information out of fewer patients. It also means that stories like this have much more of a shock and awe impact on me.

But yeah, if you have deep pockets, you use it to ensure that you will continue to have deep pockets. I would have hated to be in the meeting where they decided to take this on, and I would have hated to be the one to tell them 20,000 subjects.

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7. beltran on December 15, 2005 10:10 AM writes...

Prexige is launching now in UK and Australia and EU filing is expected early next year
http://emc.medicines.org.uk/emc/assets/c/html/displaydoc.asp?documentid=17149
In a company statement Novartis said they expect to resubmit in the US in early 2007 after its ongoing Hip-OA study using Celebrex as active comparator is complete

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8. JSinger on December 15, 2005 10:48 AM writes...

The study will be run by Steve Nissen, and he's forbidding the investigators under him from accepting money from all sides: drug companies, securities firms, trial lawyers, the lot.

This is a perfectly reasonable policy (that probbaly should be much more common) but given that Pfizer is buying them $100 million worth of data, it's hardly like critics and conspiracy theorists won't have a conflict of interest to point to.

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9. JSinger on December 15, 2005 10:51 AM writes...

Hmmmm. Just had a comment put on hold for moderation. Is it that mentioning certain pharmaceutical companies or products kicks your comment into the "Held for Moderation" bin?

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10. Derek Lowe on December 15, 2005 11:10 AM writes...

I don't know *what* triggers that moderation business. I've had it happen to me, too, and I've got comments set for anyone to publish (well, except spammers, that is). I think a few comments have been eaten by the system, too. I'll try to figure out what's going on. . .

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11. SP on December 15, 2005 12:43 PM writes...

I'll repost this, since it got sent to moderated purgatory:
"But not too many other drugs could support having an extra four-year hundred-million-dollar clinical trial piled on them. . ."
Do you mean that most drugs don't have enough sales to make a $100M trial worthwhile, or that most drugs, if subjected to such a large study, would turn up problems that don't show up in smaller trials?

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12. peej on December 15, 2005 1:05 PM writes...

Expensive trial? I see a $25MM yearly expense vs. a two BILLION dollar a year drug. My math says thats about 1% of sales revenue.

Of course, the trial they need to do is a trial comparing Celebrex vs. a typical NSAID with a PPI to see if Celebrex is useful in preventing GI bleeds. We already know that taking aspirin with Celebrex negates the benificial GI effects, so the drugs use should be much more limited than it is.

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13. Steven Jens on December 15, 2005 8:35 PM writes...

Is there any particular reason to think Celebrex is safer than Vioxx? Or do they just figure they're screwed if it isn't? Or is "as dangerous as Vioxx" acceptable if it's better in some way than tylenol and limited to the right group of payments?

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14. Jim Hu on December 16, 2005 1:07 AM writes...

When I had the comment go on hold, I had included a blockquote html tag...how about you guys?

I recall previewing it and thinking - "wow, fancy bliockquote formatting!"

The site still isn't remembering me either...

Oh, and on topic...I've been taking Celebrex for several years, so I certainly hope it gets a clean result. But as I've said on my blog, if I have an MI, it will probably be due to a weakness for fries and a lack of exersize...

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15. beltran on December 16, 2005 4:12 AM writes...

"Is there any particular reason to think Celebrex is safer than Vioxx?"
My speculation is that is related with half life: how long is Cox 2 inhibited (without Cox 1) every day for several weeks

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16. tom bartlett on December 16, 2005 8:54 AM writes...

""Is there any particular reason to think Celebrex is safer than Vioxx?""

Well for one thing (if you believe the incorrect hypothesis that selectively inhibiting COX-2 is bad-- I do not; I think Vioxx's SMALL edema issues are not mechanism-related), Celebrex has a lower selectivity ratio than Vioxx.

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17. Dr Crippen on December 18, 2005 9:32 AM writes...

Scary stuff.

We have been covering the influence of big business, in particular the effect of the big drug companies, in NHS BLOG DOC following on from the excellent exposes in HEALTH BUSINESS BLOG :(http://www.mppllc.com/pages/hbblog.html)

Billions of dollars in these drugs - and yet they will mainly be prescribed for milder, more chronic conditions which are already served by a wide array of NSAIDs

In the meantime, in the UK there is ongoing controversy about the funding for HERCEPTIN for the treatment of breast cancer.

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