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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

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February 28, 2005

Tysabri's Fall

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Posted by Derek

Well, no one's in any doubt about the main thing moving the biotech and pharma stocks today. Biogen/Idec and Elan shares got dragged through the streets and thrown into the river when they announced that they were pulling their multiple sclerosis drug, the weirdly-named Tysabri. (Here's the letter from the companies to physicians, in PDF format.)

In short, a small number of patients who where getting Tysabri along with another Biogen product (Avonex, aka beta-interferon) came down with progressive multifocal leukoencephalopathy, fortunately also known as PML. It sounds bad, and it is. While multiple sclerosis is a disease characterized by autoimmune attack on the white myelin sheathes of nerve tissue, PML is characterized by rapid, severe demyelination - sort of a multiple sclerosis on fast-forward. It's associated with activation of JC polyomavirus, a relatively obscure agent that a majority of adults carry without showing any symptoms at all. Disruption of the immune system (along with some unknown activating event) can turn the virus loose.

All this comes as today's print edition of the Wall Street Journal had a writeup on Biogen/Idec as the best-returning stock of the last ten years. Last year's 80% gain on Tysabri optimism didn't hurt, and the rest of the article is full of glowing predictions of success which are now but fragile fossils. Even if the treatment makes it back to the market, I can't see how it can ever be what it was going to be.

Tysabri's a monoclonal antibody treatment, which is one reason I haven't talked about it much on this site. That's much more biological than chemical, and I've never worked in the antibody field. But the toxicity problems that have cropped up are going to be handled just like the ones that occur with small molecules. Withdrawing Tysabri voluntarily should help some. But all you have to do this evening is type the name into Google, and you'll see that the first batch of ambulance chasers is already on the case. "Free Case Evaluation for Side Effects Victims," they say. There will be more lawyers than victims, and not for the first time. It won't slow them down much.

Comments (4) + TrackBacks (0) | Category: Toxicology


COMMENTS

1. CARRIE on March 1, 2005 10:23 PM writes...

I did 2 doses of tysabri before it was pulled off the market.

have I had side effects? its too soon to be sure--i'm on alot of other medications.

as far as the ambulance chasers, i was informed there is a risk with any drug you take. (i didn't sue my phychiatrist for overdosing me on a siezure/anti-depressant drug)

i would rather take my chances as a guinea pig and have 2 good or better years than live out 30 as a vegetable going soft inside and out.

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2. Michael Stephens on March 2, 2005 12:27 PM writes...

It's important to remember these patients were taking Tysabri in conjunction with Avonex for a long period of time. My wife had her first dose of Tysabri (w/out Avonex) last Thursday and we were very optimistic about the promise it held. It may be that they put it back on the market and have it as a stand alone product. There are currently 57 medications in the pipeline, so there is still much promise for MS patients. I think many journalists are overhyping "The most promising MS drug in years". Rebif was approved in 2002. That was the most promising drug since 1996. It only took another 2 years for the next drug to come out. With as many drugs in the pipeline as there currently are, there is still much hope for MS patients. The death of the Tysabri patient was a tragedy, but by no means is it the death of hope for MS patients.

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3. John on March 7, 2005 10:05 PM writes...

Tysabri:

Like cigarettes; Can't there be a disclaimer, TO GET THIS MEDICATION TO CUSTOMERS NOW?

"USE THIS MEDICATION HAS CAUSE 1 FATALITY AND 1 ILLNESS"

I think other MS treatments have a limit of time to use.

and these to unfortunate, TYSABRI, cases were when the customers were in their 37 month of treatment and were both on 2 MS medications.

I had been on Betaseren for the last 123 months and my body has been riden with scar tissue and subcue shots cannot be effectively administered.

I have had 2 treatments of TYSABRI and I'd like to do 10 more months, at least. This is far less months than the 3 years the above customers.

I say at least a year on this medication and maybe the oral treatment will FDA ok'd there, or I can return to Betaseran
Maybe

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4. John on March 7, 2005 10:25 PM writes...

This is an adjustment to the above Post:

Tysabri: Like cigarettes- which can cause death; Can't there be a disclaimer, TO GET THIS MEDICATION TO CUSTOMERS NOW? "USE of THIS MEDICATION HAS CAUSED 1 FATALITY AND 1 ILLNESS" I think other MS treatments have a limit of time to use. and these 2 unfortunate, TYSABRI, cases were when the customers were in their 37 month of treatment and were both on 2 MS medications. I had been on Betaseren for the last 123 months and my body has been riden with scar tissue and subcue shots cannot be effectively administered. I have had 2 treatments of TYSABRI and I'd like to do 10 more months, at least. This is far less months than the 3 years the above customers. I say at least a year on this medication and maybe the oral treatment will FDA ok'd? or I can return to Betaseren or something else NEW and improved?

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