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Friday, August 04, 2006

Failures to Follow

I've mentioned that Cell Therapeutics spent over 878 million dollars put one drug on the market, which they sold for 70 million. They are left with one more candidate that will make or break the company. So far the drug has failed miserably in clinical trials. What other companies failed, how much did it cost and what was learned?

Cancervax was a one drug company. Their drug was a cancer cell that displayed over 20 antigens that would provide an immune response that would rain hellfire down on a tumor. That's what they said at least. It failed clinical trials and the company folded. The drug itself was 20 years in the making. How much money went into the notion that this would work? The answer to that would be hard to sum up. Let's just assume it's over 100 million dollars. The lessons learned are also not clear. This sort of thing happens all the time. This month in biotech:

PDL Biopharma Inc. Reports Results From Phase 3 Trial Of Terlipressin In Type 1 Hepatorenal Syndrome - Did Not Meet Its Primary Endpoint

NPS Pharmaceuticals faces a class action suit for making allegedly false statements about the prospects of osteoporosis drug PREOS.

Icagen Inc. said Friday it is cutting out approximately half of the patients involved in a late-stage study on the recommendation of an independent data monitoring committee. The announcement sent shares in a nosedive, dropping $3.26, or 77.1 percent

Takeda Pharmaceutical has informed BioNumerik Pharmaceuticals that it is considering terminating their alliance over Tavocept after the drug candidate failed to meet the primary endpoints of two phase III trials in cancer patients.

You get the idea. Many big ideas turn into dust and alot of money disappears. There are of course a few success stories. The Cargo Cult Scientist however is a study on things that don't work. It is meant to be an exercise in striving towards the positive, starting from the negative. The negative being things that don't work. What is so shocking about making drugs is how much money gets dumped into things that don't work. I began this post by asking who failed, how much did it cost and what was learned. The answer is that every month there is going to be a number of big projects that fail, costing millions and millions of dollars, and nothing is being learned from it.

The Cargo Cult Scientist has learned something about PREOS however. The active ingredient in PREOS is parathyroid hormone (PTH). Forteo is also a PTH drug that is on the market. There are still other PTH drugs trying to make it to the market as well. How will we know if they will make it or not? We at least know a drug containing PTH is not gaurenteed to work. Curious. It is highly possible that a new clinical trial could show PREOS to be effective. What seems to be not working here are clinical trials. This is the true Cargo Cult Airport. Clinical trial professionals are not very good at reproducing results. There is a need for reform but first we simply state the obvious, clinical trials are not run scientifically. How can we fix the situation and what is at stake? More later.

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