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Long-Term Copaxone(R) Study Showed 92% of Multiple Sclerosis Patients Were Still Walking Unaided After a Mean of 10 Years on Treatment

10-Year Data from the Longest Continuous Prospective Study of Any MS Drug

KANSAS CITY, Mo., May 8 /PRNewswire-FirstCall/ -- Data from a 10-year
long-term study showed that 92 percent of relapsing-remitting multiple
sclerosis (RRMS) patients in the study who remained on COPAXONE(R)
(glatiramer acetate injection) were still walking without assistance
despite an average disease duration of more than 15 years. These results
were published in the June 2006 issue of the journal Multiple Sclerosis,
which was mailed today.
This study represents the only prospective, open-label follow-up of
more than 10 years' duration designed to evaluate continuous
immunomodulatory therapy in RRMS patients. The study has been extended to
15 years.
"COPAXONE(R) provides RRMS patients with a treatment option that has
demonstrated long-term efficacy and safety," said Corey Ford, M.D., PhD,
Associate Professor of Neurology, Director of the Multiple Sclerosis
Specialty Clinic and Medical Director of Pharmacy at the University of New
Mexico Health Sciences Center and an investigator in the study. "Results of
the study are consistent with the presumed mechanism of action of
COPAXONE(R), which appear to treat inflammation and neurodegeneration, the
underlying pathologies of multiple sclerosis."
Patients who remained in the study and were on COPAXONE(R) had a
relapse rate reduction of more than 80 percent over a mean of 10 years in
the trial. On average, patients experienced only one relapse every five
years compared to an average of 1.18 attacks a year before entering the
study.
A favorable safety profile was maintained over the course of the study.
The most common adverse events associated with COPAXONE(R) were local
injection-site reactions and immediate post- injection reactions. No other
immune- mediated disorders, infections, or malignancies were reported.
This study of COPAXONE(R) (glatiramer acetate injection) in 251 RRMS
patients began in 1991 as a double-blind, placebo-controlled trial in which
patients were randomized to receive either COPAXONE(R) 20 mg or placebo by
subcutaneous injection daily for a mean of 30 months. A total of 232
patients (125 COPAXONE(R) and 107 placebo, the modified intent-to-treat
cohort, or mITT) were evaluated in this analysis.
After double-blind treatment, all patients were offered COPAXONE(R) as
part of an ongoing, prospective, open- label study. All of the original 11
U.S. study sites participated, and these patients were evaluated every six
months. Patients were also examined, usually within seven days, if they
experienced symptoms suggestive of a relapse. After 10 years, 108 patients
of the 232 remained in the study on COPAXONE(R).
Investigators looked at the percentage of patients who progressed to
Kurtzke Expanded Disability Status Scale (EDSS) 4 -- a stage at which they
were still ambulatory despite moderately severe disability; EDSS 6 -- a
level at which a cane, crutch or brace is required for mobility; and EDSS 8
-- a state in which the patient is wheelchair-bound.
At the start of COPAXONE(R) treatment, patients had an average EDSS
score of 2.79. At 10 years, the ongoing patient group on COPAXONE(R) showed
significantly decreased accumulation of disability, with 24 percent of
patients reaching EDSS 4, eight percent reaching EDSS 6 and only one
percent reaching EDSS 8 compared with 68 percent, 50 percent and 10 percent
respectively in the withdrawn with long-term follow-up visit (LTFU) cohort.
The 50 patients who withdrew from the trial and returned for the
10-year LTFU showed significantly increased disability compared with
ongoing patients treated with COPAXONE(R). The mean increase in EDSS score
was 2.24 points in those patients who withdrew compared with a 0.50 point
increase in patients remaining on COPAXONE(R) (p<0.0001). Similarly, 62
percent of the ongoing COPAXONE(R) patients had stable or improved EDSS
scores.
"The results from this trial and the fact that patient safety was
maintained over time make these data clinically useful for the MS
community," said Ford. "No other immunomodulatory agents used to treat
multiple sclerosis have been followed continuously for as long as
COPAXONE(R)."
After a mean of 10 years, patients who continued COPAXONE(R) treatment
showed significantly less disability than those who withdrew from the study
and returned for the long-term follow-up visit. This was evaluated using
the EDSS.
"COPAXONE(R) was shown to maintain efficacy over the long term. As a
group, the patients who remained in the study had no significant changes in
EDSS -- even after 10 years of treatment," said Ford.
About COPAXONE(R)
Current data suggest COPAXONE(R) (glatiramer acetate injection) is a
selective MHC class II modulator. COPAXONE(R) is indicated for the
reduction of the frequency of relapses in RRMS.
The most common side effects of COPAXONE(R) are redness, pain,
swelling, itching, or a lump at the site of injection, weakness, infection,
pain, nausea, joint pain, anxiety, and muscle stiffness.
COPAXONE(R) is now approved in 44 countries worldwide, including the
United States, Canada, Mexico, Australia, Israel, and all European
countries. In Europe, COPAXONE(R) is marketed by Teva Pharmaceutical
Industries Ltd. and sanofi-aventis. In North America, COPAXONE(R) is
marketed by Teva Neuroscience, Inc.
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA), headquartered in
Israel, is among the top 20 pharmaceutical companies in the world. Close to
90 percent of Teva's sales are in North America and Europe. The company
develops, manufactures, and markets generic and branded human
pharmaceuticals and active pharmaceutical ingredients. Teva's innovative
R&D focuses on developing novel drugs for diseases of the central nervous
system.
Teva Pharmaceuticals USA and Teva Neuroscience, Inc. are subsidiaries
of Teva Pharmaceutical Industries Ltd. Teva Neuroscience, Inc. markets
COPAXONE(R). COPAXONE(R) is a registered trademark of Teva Pharmaceutical
Industries Ltd.
See additional important information at
http://www.COPAXONE.com/pi/index.html or call 1-800-887-8100 for electronic
releases. For hardcopy releases, please see enclosed full prescribing
information.
Safe Harbor Statement under the U. S. Private Securities Litigation
Reform Act of 1995: This release contains forward-looking statements, which
express the current beliefs and expectations of management. Such statements
are based on management's current beliefs and expectations and involve a
number of known and unknown risks and uncertainties that could cause Teva's
future results, performance or achievements to differ significantly from
the results, performance or achievements expressed or implied by such
forward-looking statements. Important factors that could cause or
contribute to such differences include risks relating to Teva's ability to
rapidly integrate Ivax Corporation's operations and achieve expected
synergies, Teva's ability to successfully develop and commercialize
additional pharmaceutical products, the introduction of competitive generic
products, the impact of competition from brand-name companies that sell or
license their own generic products under generic trade dress and at generic
prices (so called "authorized generics") or seek to delay the introduction
of generic products, regulatory changes that may prevent Teva from
exploiting exclusivity periods, potential liability for sales of generic
products prior to a final court decision, including that - relating to the
generic versions of Allegra(R), Neurontin(R), Oxycontin(R) and
Zithromax(R), the effects of competition on Copaxone(R) (glatiramer acetate
injection) sales, the impact of pharmaceutical industry regulation and
pending legislation that could affect the pharmaceutical industry, the
difficulty of predicting U.S. Food and Drug Administration, European
Medicines Association and other regulatory authority approvals, the
regulatory environment and changes in the health policies and structure of
various countries, Teva's ability to successfully identify, consummate and
integrate acquisitions, exposure to product liability claims, dependence on
patent and other protections for innovative products, significant
operations outside the United States that may be adversely affected by
terrorism or major hostilities, fluctuations in currency, exchange and
interest rates, operating results and other factors that are discussed in
Teva's Annual Report on Form 20-F and its other filings with the U.S.
Securities and Exchange Commission. Forward- looking statements speak only
as of the date on which they are made and the Company undertakes no
obligation to update publicly or revise any forward- looking statement,
whether as a result of new information, future developments or otherwise.
Contact:
John Shaw
Teva Neuroscience
(816) 508-5062
john.shaw@tevaneuro.com


SOURCE Teva Pharmaceutical Industries Ltd.
Web Site: http://www.COPAXONE.com/pi/index.html

Dunmann,

You beat me with this post.

What I hate about this type of research is that it looks very impressive, but no guarantees are given with these drugs when you start i.e. can Teva guarantee that I will be walking unaided in ten years time if I start?

The results always look impressive - as long as you stay on the drugs forever etc etc.

Ian

Ian,

It's not easy to beat the master poster!

There does seem to be a degree of flakiness with this article... not to mention that it comes directly from Teva. Nevertheless, I hope it is true as a Copaxone user myself. As per a guarantee, I can't imagine any bio-tech company would or could guarantee any product, especially MS as we know how individualized the disease course can run. Although it would be nice to have one.

80 % reduction in relapses sure beats the ~30% commonly attributed to the CRAB drugs. However, we again come back to the question - what about the people who discontinued use of Copaxone during the 10-year study due to ineffectiveness? Seems skewed, but I too hope there's some merit to this study, being a C user myself.

Dunmann,

You are a newbie - Dignan and myself are the masters. Your time will come - just be patient.

It's interesting that Copaxone is being trialled with interferons. So the 80% effectiveness of Copaxone with the 30% effectiveness of an interferon will give us 110% reduction in relapses.

Ian

So the 80% effectiveness of Copaxone with the 30% effectiveness of an interferon will give us 110% reduction in relapses.

Funny!

I like your math.

It's maths Dunmann - short for mathematics. You Americans have given the world so much, but you've taken the Queen's English and corrupted it.

In future only English spelling is allowed on this site -Arron had given his approval to this.

Gray - no. It's grey.
Color - no. It's colour.

It was a big mistake for you Americans to seek independence - if you'd stuck with us you'd have a future King Charles and Queen Camilla. And you'd be able to spell properly.

Ian

I am insulted! How dare you assume that I am American... how British of you. I am in fact Canadian! A Canadian with a British/Canadian passport.

"Canadian English spelling is a mixture of American, British, and unique Canadianisms" Wikipedia

American... Ha!


P.S. How do you say aluminum???? Well that just sounds silly!

Apologies Dunmann. But on the good side at least you are not French-Canadian.

Keep up the postings - another 700 and you'll be catching up with me.

Ian

In future only English spelling is allowed on this site -Arron had given his approval to this.

Haha, Ian... although I somehow always spell "grey" the British way... perhaps because every day I spent in London was just that, and it eventually came to define the word for me outright ;)

Arron,

My family survived the blitz in London. We can trace our London heritage back to the 14th Century. I won't have a word said against it. It's the centre of the universe. You continue sunning yourself in California.

I know this is off-thread but Dunmann started it.

On a serious note - sometimes when I post or PM I get a banned by the adminstrator logo. Is it just me or do others get this?

Ian

This is all very confusing. I'll have to have a sit on my chesterfield in my igloo and watch the beavers for awhile, then I think I will be able to understand this banter.