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Cardiovascular Disease

Onward With CETP!

Merck is damning the torpedoes and going ahead with its CETP program. A committee has reviewed the data so far for futility, and recommended no changes, so (as FierceBiotech says), they’re pretty much locked in now for the rest of the study, which finishes up in 2017. A mere 30,000 patients (!) are involved, which is what you’re facing when you go for the huge cardiovascular targets.

As far as I know, the other competitor left in this . . .well, I was going to say “race”, but what I actually mean is “demolition derby”, is Amgen. They recently bought a small company (for $300 million upfront) with a CETP compound of their own, which really takes an odd mixture of sunny optimism and complete sang-froid at this point. The most recent CETP vehicle to be towed off the field was Eli Lilly’s, and the wreckage from their efforts and many others is still scattered all over the place.

When talking about programs like this, though, I like to mention that despite deals costing in the hundreds of millions of dollars, and despite multiyear clinical trials with tens of thousands of patients, we all do have to remember that it only takes $43 million dollars to develop a drug. Amgen and Merck need to keep this in mind; surely it’ll help settle their nerves a bit to realize that they’re not spending as much money as they imagine. Not to worry!

Update: OK, let’s have some fun with that number. $43 million divided by 30,000 patients is $143 1433 per head. If the trial runs until mid-2017, then (since it began in 2011), to have spend $43 million on just this one trial – ignoring all the others, ignoring all the other R&D costs until now – Merck will need to have spent about sixty cents per patient per day. I think that their expenses might be running a bit higher than that. . .

19 comments on “Onward With CETP!”

  1. tally ho says:

    In comparison to PCSK9, are there sufficient examples of a strong correlation between genetic CETP loss-of-function and healthy human phenotypes? A (very) quick look gives the impression that CETP loss-of-fuction may not be as clearly correlated with health, coronary or otherwise.

  2. Al says:

    That $43M figure came from someone at the University of Victoria in British Columbia

    I see we now need to solve a math problem to post.

    A cunning strategy to exclude Canadians from posting?

    1. Mat says:

      Nah, a hopefully clever scheme to cut the spam bots out of the loop.

  3. Travis says:

    I think your calculation suffered a decimal point shift — but still, even $1433 per head ends up at less than a buck a day.

  4. Gogoosh says:

    Perhaps the math problem you need to solve to post should be 43 million divided by 30,000. The answer is not 143, Derek

  5. smurf in kent says:

    A few years ago I had several open positions in my group, we were looking for biophysical chemists with an open mind for drug discover. The slots were ideal for fresh PhDs or junior post docs. I kept the job description very broad, and insisted on reviewing every single CV myself. After approximately 60 telephone interviews we invited about 9 candidates for the interviews. Some of them were really good, but did not accept the (pretty decent) offer. We managed to fill the slots but it was anything but easy. To be clear: the whole STEM shortage story is a big fat lie, especially here in the UK, still, I was surprised how problematic is was to get good people on board.

    1. Morten G says:

      How many years was this for?
      Was there a relocation package?
      Was there a relocation package for the end of the contract?
      When you say generous severance what is that exactly in £? Or $ for that matter.
      Why are you surprised that the very best of 60 candidates, with good enough CVs that you wanted to talk to them on the phone, also got other offers?

    2. tangent says:

      Smurf, from 60 phone screens you managed to generate 9 interview candidates, and from 9 interviews you were able to make, what 3+ offers? In my area that’s a very high rate, especially that interview-to-offer rate is like it’s raining money.

      So count your blessings, you must have a very strong pool of chemists! Count your blessings you’re not *in* that pool yourself.

  6. anchor says:

    Leap of faith!

  7. gippgig says:

    I nominate Gogoosh for comment of the year.
    Who says there isn’t a STEM shortage?

  8. Nick K says:

    What happened to the famous $43M figure? Have Light and Warburton ever tried to revive the idea after the pillorying and ridicule they received on this blog and elsewhere?

  9. gippgig says:

    Off topic but may be of interest: The TV show White House Chronicle (Nov. 15 9AM Channel 26 (PBS) in Washington, D.C. area) is on the launch of a global effort to find treatments for glioblastoma multiforme.

  10. I was working on a drug development budget a few years ago and had an opportunity to chat with a few of the big CROs about costs.

    A good rule of thumb is that a phase 3 trials costs about $10,000 – $15,000 per patient per year. If we assume Merck has some economies of scale and use the lower part of the range, a 3 year, 30,000 patient trial would come to $900M.

    Close enough to $43M right?

    1. Hap says:

      What’s an order of magnitude or so between friends?

    2. Drug Developer says:

      Re: $10-15K/patient/year in Phase 3 — Definitely the right order of magnitude, although it can vary widely by visit frequency, treatment duration, inclusion of expensive procedures/imaging, etc.

      My uninformed guess is that this trial is costing Merck $500MM-$1B. I can’t imagine anything less.

  11. sp3 says:

    From Roger Perlmutter in the 4Q2014 earnings call at the end of January, 2015:

    “In November, we presented the results of the IMPROVE-IT trial demonstrating that Vytorin provides significant benefit versus simvastatin in reducing the risk of major cardiovascular events in patients hospitalized following an acute coronary syndrome. The fact that two different mechanisms of LDL cholesterol lowering – HMG-CoA reductase inhibitors, that is statins, and cholesterol absorption inhibitors, that is Zetia – both reduce cardiovascular risk suggests that LDL cholesterol is itself the target of action of these drugs and augurs well for the favorable outcome in the REVEAL study of anacetrapib.”

    In other words, LDL lowering will likely be enough for anaceptrapib to prove effective. The main worry is the very long terminal half life, which Merck has also disclosed. Therapeutic levels of drug stay on board even a year after discontinuing treatment.

  12. SteveM says:

    Re: “Some of them were really good, but did not accept the (pretty decent) offer.”

    Given the way supply and demand is supposed to work, the offers weren’t “decent” enough…

  13. Glen says:

    The best justification for super-size drug companies is that they then have the resources to carry through large projects. Definitive information from such a large test program will benefit everyone to some degree.
    Cardigan, did you say?

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