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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: Don't miss Derek Lowe's excellent commentary on drug discovery and the pharma industry in general at In the Pipeline

In the Pipeline

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August 1, 2011

Laquinimod Fails For Multiple Sclerosis

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Posted by Derek

If you haven't been reading carefully, you might have had trouble figuring out Teva's oral therapy for multiple sclerosis, laquinimod. After all, earlier this year, the company was blowing the horn for the compound at neurology meetings, touting how safe and effective it was, its advantages over existing therapies, and its potential in the market. You'd hardly know that the compound actually didn't perform as well as many people were hoping. And of course, that very article does mention, near the end, that the company was going to have some more results later in the year. . .

. . .and that day has arrived. Unfortunately. Laquinimod missed its primary endpoint of reducing relapses in MS patients, and unless Teva and its Israeli Swedish partner company (Active Biotech) have some real surprises to unveil, you'd have to presume that the compound is dead. Or if not dead, destined to never make much of an impact in the market, for sure. This program has had a long history, with an earlier version of the structure (roquinimex) running into severe cardiovascular issues ten or twelve years ago.

Teva is a huge player in the generic world, and in recent years has been trying to break into the research end of the drug business. (Their first was Copaxone (glatiramer acetate), also for MS, a compound with a tangled history). Enjoy the experience, guys. If you're used to dealing with compounds whose value has already been proven, this sort of thing must come as even more of a shock than usual.

Comments (19) + TrackBacks (0) | Category: Clinical Trials | The Central Nervous System


COMMENTS

1. Anonymous on August 1, 2011 1:10 PM writes...

Enjoy the experience, guys. If you're used to dealing with compounds whose value has already been proven, this sort of thing must come as even more of a shock than usual.

Ha ha! FACE!

Permalink to Comment

2. processchemist on August 1, 2011 1:22 PM writes...

And this despite the very careful attitude of Teva about inlicensing assets (phase II, III better)... Maybe, and I say maybe, the absence of an inhouse culture about drug development doesn't help, but we saw many big guys face the same kind of results...

Permalink to Comment

3. Anonymous on August 1, 2011 2:00 PM writes...

Active Biotech is a swedish biotech not Israeli.
It was formed in the mid-nineties, when Pharmacia decided to close down its site in Lund.

Permalink to Comment

4. anchor on August 1, 2011 2:20 PM writes...


I am not surprised. TEVA has still ways to go, before it get it right when it comes to trials and such. TEVA is a great generic company and may be they should stick with that business model.

Permalink to Comment

5. Jonny on August 1, 2011 4:47 PM writes...

It seems that some of the comments (and even dare I say it the original post) are a little smug about TEVA's failure with this compound.

I wouldn't have thought they would have gone into this with an attitude of "innovator drug development is easy", and the experiences of multiple pharma and biotech companies in drug development only reinforces how difficult it is to select optimal compounds for development, no matter the prior experience. (Think back to Pfizer and Dimebon for a notorious in-licensing example.)

Permalink to Comment

6. drug_hunter on August 1, 2011 5:47 PM writes...

The Cephalon folks know what they're doing, which should help...

Permalink to Comment

7. drug_hunter on August 1, 2011 5:49 PM writes...

The Cephalon folks know what they're doing, which should help...

Permalink to Comment

8. lester freamon on August 1, 2011 5:52 PM writes...

Anyone know what the target of laquinimod is? My five minutes of googling and pubmeding turned up nothing...

Permalink to Comment

9. Boghog on August 2, 2011 1:27 AM writes...

@lester freamon
I can't find anything either. It appears that the target is unknown. See for example:

Tselis A.
Curr Opin Investig Drugs. 2010 May;11(5):577-85.
PMID: 20419604

Permalink to Comment

10. Anonymous on August 2, 2011 3:41 AM writes...

We need to cheer on companies to succeed, not mock those who fail. "Yeah, you suck just as much as us!"

Permalink to Comment

11. Dr. Van Nostrand on August 2, 2011 3:51 AM writes...

@3: That is correct. Teva is the Israelian company, Active Biotech is Swedish

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12. Pharmachick on August 2, 2011 4:07 AM writes...

Oh dear ... its been a while since I've commented, Derek, but I've been lurking.

This is actually rather sad ... I've been following laquinimod with interest (if not any real belief since I figure any company pushing an experimental THIS hard... well there has to be a drawback).

Anyways, I was hoping hard for this one against available evidence (and against the worryingly ridiculous OTT press releases) because a close friends Dad is just entering final phase of real bad MS.

DAMMIT!

Permalink to Comment

13. petros on August 2, 2011 4:42 AM writes...

Apparently via indirect modulation of TLRs

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2671563/

Permalink to Comment

14. sepisp on August 2, 2011 5:56 AM writes...

Interesting how laquinimod was a simple modification of an earlier attempt that failed because of cardiotoxicity. One aryl position was chlorinated and a methyl was switched to ethyl to give an amide of an arylethylamine. I assume they figured the hit was real, and just proceeded to fix the cardio problem, and it's impressive to see improvement in the physical size of lesions (by MRI), but it's the results and only the results that count. It did reduce relapses, in fact, but below competition.

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15. cathy247 on August 2, 2011 9:31 AM writes...

Roquinimex (the original compound) was the best drug I ever used to treat my M.S., I felt 'normal' which is all I ever wanted plus it was a pill not a shot. Minocycline has stopped my relapses but I'd still like the option of using Laquinimod (haven't persuaded my Neurologist yet) as I have waited years since they pulled Roquinimex for the privilege!!

Permalink to Comment

16. simpl re Teva on August 2, 2011 12:12 PM writes...

Teva is an aggressive competitor of the Pharma R&D business model, no need for any lovey-dovey here. Through fast generic price erosion, it causes higher prices for new drugs, and its litigation competes with the R&D budgets of others. Often such companies became R&D companies to improve margins - Serono is an example I know of - but not Teva, yet.
I'm not saying that R&D Pharma are nicer folks than Generics, mind.

Permalink to Comment

17. Konstantinos Spigos on August 2, 2011 2:00 PM writes...

Laquinimode putatively shifts immune response to Th2 type, reduces immune cell infiltration into the CNS and induces myelin and axonal preservation, with no evidence for immunosuppression
http://www.ncbi.nlm.nih.gov/pubmed/21450529

Permalink to Comment

18. LF Velez on August 2, 2011 2:32 PM writes...

Just looking at the name, I was expecting the MOA to be something like fingolimod [FTY-720, now Gilenya, I think]...

On another note, the wiki entry for laquinimod has one of the most awkward sentences I've seen on that site:

"In 2011 Teva announced that its clinical trials involving Laquinimod had failed, being unable to significantly reduce relapses into multiple sclerosis among patients beyond what a placebo was."

Permalink to Comment

19. Emily on October 8, 2011 11:58 AM writes...

I guess I should have been following the news. I was in the original Bravo study and have been in the extension since May. I found this site yesterday evening. I received a call from my doctors office stating they had a letter to mail to me. She said my doctor would be calling me at some point. The letter states I was assigned the placebo arm of the original study. I knew that I would not find out what arm I was in until the medication received FDA approval or the study was discontinued. I received the call at 4:50 pm on a Friday. There is nothing I can do. I wish they would have told me about the results sooner. During the summer they just told me it was really promising and was on the way to approval.

Permalink to Comment

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