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Study finds that high dose of MS drug works better
Reuters ^ | 4/5/06 | Deena Beasley

Posted on 04/05/2006 5:00:23 PM PDT by wagglebee

LOS ANGELES (Reuters) - A high dose of Teva Pharmaceutical Industries Ltd.'s multiple sclerosis drug Copaxone is more effective at limiting relapses and brain lesions than the standard dose, without more side effects, researchers said on Wednesday.

"For some people a higher dose may work better," said Dr. Jeffrey Cohen of the Cleveland Clinic's MS research center and lead investigator of a small nine-month trial comparing the two doses.

The study, funded by Israel-based Teva, found that a 40 milligram injection of Copaxone reduced inflammatory disease activity 38 percent more than a 20 mg dose.

Rates of side effects, mainly injection site reactions, were unchanged, Cohen said.

Sales of Copaxone, co-marketed by Sanofi-Aventis, grew 26 percent globally in 2005. Teva Vice President Rivka Kreitman attributed the trend to increased awareness of the drug's effectiveness.

Copaxone is approved to treat relapsing-remitting multiple sclerosis, the most common form of the disease, which causes a progressive disability that can include blurred vision, weakness, poor muscle coordination and loss of memory and mental function as nerves lose their insulating sheath.

The study of 90 patients not previously treated with the drug also showed that the double dose reduced relapse rates by 77 percent compared to rates before the trial, while the lower dose cut relapses by 62 percent.

The time to the first relapse was stretched to 213 days from 80 days, Teva said.

The company said it plans to launch in the second half of this year a large-scale Phase III study designed to confirm the findings, which were presented at a San Diego meeting of the American Academy of Neurology.

Those results are expected in 2008, Kreitman said.

The Teva drug competes with MS treatments from Switzerland's Serono SA, the U.S.'s Biogen Idec and Germany's Schering AG.

Current MS drugs are only partially effective, suppressing disease symptoms by about 30 percent, Cohen said.

"Patients continue to have disease activity despite being on medication ... we are very encouraged by these results suggesting that a higher dose of Copaxone may be more effective," he said.

The drug's sales totaled $1.18 billion in 2005, of which $782 million were in the United States, where Copaxone increased its market share to more than 34 percent of new prescriptions, Teva has said.

The drug sells for about $20,000 a year in the United States, according to Kreitman.

Copaxone's use is up amid wariness over risks of interferons, like Serono's Rebif and Biogen's Avonex, which can include development of neutralizing antibodies that render the drugs ineffective, Cohen said.

Teva and partner Lunbeck A/S in March halted development of an oral version of Copaxone, saying the formulation never lived up to expectations.

Kreitman said Teva expects to announce toward the end of this year results from a mid-stage trial of its experimental oral MS drug called Laquinimod.


TOPICS: Culture/Society; News/Current Events
KEYWORDS: copaxone; medicine; ms; multiplesclerosis; tevapharmaceutical
The time to the first relapse was stretched to 213 days from 80 days, Teva said.

That sounds promising.

1 posted on 04/05/2006 5:00:26 PM PDT by wagglebee
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To: cgk

MS Ping.


2 posted on 04/05/2006 5:00:40 PM PDT by wagglebee ("We are ready for the greatest achievements in the history of freedom." -- President Bush, 1/20/05)
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To: wagglebee

Has anyone heard of this drug being used for systemic inflammatory diseases, such as Lupus or RA?


3 posted on 04/05/2006 5:08:55 PM PDT by wouldntbprudent (If you can: Contribute more (babies) to the next generation of God-fearing American Patriots!)
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To: wagglebee

Yes, it really does. Other than the cost of the med itself, I can't find any downside in the story.


4 posted on 04/05/2006 5:13:55 PM PDT by lindor
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To: wagglebee
Study finds that high dose of MS drug works better

Oh great.

Now Bill Gates is pushing drugs.......although, come to think of it, might be handy when dealing with some of the MS apps / OS's.

5 posted on 04/05/2006 5:15:41 PM PDT by LasVegasMac (Islam........not fit for human consumption.)
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To: wagglebee

Good, thanks, I was going to ping our friend.


6 posted on 04/05/2006 5:19:58 PM PDT by Bahbah (Harry Reid is a Liar)
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To: wagglebee; 2ndClassCitizen; Born Conservative; cva66snipe; dawn53; Deut28; Draco; dredhawk; ...
Thank you so much for the ping, wagglebee! :)

MS ping!

Please FReepmail me if you would like to be added to, or removed from, the Multiple Sclerosis ping list...

7 posted on 04/06/2006 11:12:56 AM PDT by cgk (I don't see myself as a conservative. I see myself as a religious, right-wing, wacko extremist.)
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To: wagglebee

This does sound promising. Higher doses in certain drugs do seem to be less detrimental than previously thought we keep hearing.

Rebif, the drug I was prescribed, is IIRC, a higher dose of the same drug in Beta Seron, one of the ABC-R drugs for MS (avonex, beta seron, copaxone, and rebif). The neuros when I was diagnosed 5 years ago pushed me towards Beta Seron, but honestly the side effects scared the beejezus out of me. When Rebif was approved for use in the USA a couple years later, I read up on it, and while it had many of the same yucky side effects, it sounded much better for what I was experiencing.


8 posted on 04/06/2006 11:18:31 AM PDT by cgk (I don't see myself as a conservative. I see myself as a religious, right-wing, wacko extremist.)
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To: Bahbah

:) You are a sweetie.


9 posted on 04/06/2006 11:18:59 AM PDT by cgk (I don't see myself as a conservative. I see myself as a religious, right-wing, wacko extremist.)
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To: lindor
Rates of side effects, mainly injection site reactions, were unchanged, Cohen said

I use Betaseron and don't really have any side effects other than site reactions.

But I've read about the breathing/chest pain episodes that some people get, on occasion, from Copaxone.

This article seems to indicate that even though they increase the dose, that particular side effect is not worse...which I'm sure is good news to a Copaxone user.

10 posted on 04/06/2006 11:23:20 AM PDT by dawn53
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To: cgk

I was a little leery of the side effects from Beta...but ended up not having them, thank goodness.

By the way, ABC-R in it's latest form (online anyway) has morphed into CRAB drugs, LOL.

Don't know if that's a good acronym of not, LOL!


11 posted on 04/06/2006 11:25:43 AM PDT by dawn53
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To: cgk

Thanks for the ping.

Don't know if this has been posted before but the NMSS has a site now called http://www.faceofms.org.

It's really interesting. Neil Cavuto has three tiles on the board, and all are very interesting enlightening about how he deals and views his MS.

Lots of other people to listen to or read their stories...it's sort of an addicting website (but not as addicting as FR, LOL.)


12 posted on 04/06/2006 11:28:58 AM PDT by dawn53
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To: dawn53

CRAB drugs - LOL.... I was going to type that out of habit, and corrected myself to the "proper" acronym. Seriously, it does seem suitable, because having this disease sure makes you feel like one some days! ;)


13 posted on 04/06/2006 12:10:59 PM PDT by cgk (I don't see myself as a conservative. I see myself as a religious, right-wing, wacko extremist.)
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To: dawn53

WOW what a fantastic site! Thanks for the link! It looks like I'll be spending a lot of time there. I'm always interested in reading how others deal with what we have... it's always fascinating to me.


14 posted on 04/06/2006 12:12:04 PM PDT by cgk (I don't see myself as a conservative. I see myself as a religious, right-wing, wacko extremist.)
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