COPAXONE(R) Only MS Therapy Available Without Warnings or Precautions for Liver Damage

Main Category: Multiple Sclerosis
Article Date: 20 Mar 2005 - 18:00 PDT


Given the recent news surrounding the multiple sclerosis (MS) therapies, Teva Neuroscience announced today that COPAXONE(R) (glatiramer acetate injection) is the only available relapsing-remitting MS (RRMS) therapy that does not carry a warning or precaution for liver damage and does not require additional laboratory testing. This clarification is important due to recent announcements regarding two approved products in the MS market. The recent marketing suspension on one newly approved product and the FDA-issued warning for liver damage on the other prompted Teva Neuroscience to clarify the attributes of COPAXONE(R).

The multiple sclerosis community is asking tough questions about MS therapies. Teva Neuroscience, a leader in the field of neurology, understands the concern and confusion weighing on the minds of people living with MS and their carepartners. The company wants to reassure both physicians and patients that there is a wealth of data to support the efficacy and safety of their product, COPAXONE(R).

The science behind COPAXONE(R) has been developed over many years, including an ongoing, long-term, prospective extension trial that has spanned the last 12 years. The importance of researching and weighing the evidence when selecting a therapy is critical. COPAXONE(R) is an RRMS therapy supported by three Class I Phase III trials (prospective, randomized, and controlled) establishing efficacy and safety(1,2,3). "Class I" means the studies met the highest standards for quality according to experts(4).

The three studies included two two-year studies, showing how effective COPAXONE(R) (glatiramer acetate injection) is in reducing relapses over the long term(1,2). One of the two-year studies was extended as an open-label trial to 12 years with a commitment to extend to 15 years -- making it the longest continuous study ever of patients with RRMS(5). A third study showed people on COPAXONE(R) had steady reductions in the number of new brain MRI lesions(3). Furthermore, COPAXONE(R) is presumed to have a dual mechanism of action both outside and within the central nervous system (where MS is active) to reduce inflammation at the site of brain lesions(6,7).

Following stringent regulatory review, COPAXONE(R) has received approval for treatment of RRMS in 42 countries worldwide. These approvals were based on well-controlled Phase III trials demonstrating efficacy, safety, and tolerability.

Additionally, numerous other open-label studies have supported the effectiveness of COPAXONE(R)(8-12). Clinical experience with COPAXONE(R) has led to endorsement of its use in published guidelines by the American Academy of Neurology, the National Multiple Sclerosis Society, and the Association of British Neurologists.

"We want people living with MS to feel confident in their therapy decision and take comfort in the fact that COPAXONE(R) has been studied for more than a decade and does not carry a precaution or warning for liver damage," said Larry Downey, Teva Neuroscience President and Chief Executive Officer. "In addition to clinical data, COPAXONE(R) has more than 340,000 patient-years of exposure in post-marketing data through November 2004."

As part of its commitment to the MS community, Teva Neuroscience created Shared Solutions(R), a free service offering support, knowledge, and answers for anyone affected by MS. People living with or touched by MS are encouraged to call Shared Solutions(R) at (800) 887-8100 for answers to questions about living with the disease and drug therapy.

About COPAXONE(R)

The FDA has approved drugs for RRMS, such as COPAXONE(R). Current data suggest COPAXONE(R) is a selective MHC class II modulator. COPAXONE(R) is indicated for the reduction of the frequency of relapses in relapsing- remitting multiple sclerosis.

The most common side effects of COPAXONE(R) (glatiramer acetate injection) are redness, pain, swelling, itching, or a lump at the site of injection, flushing, chest pain, weakness, infection, pain, nausea, joint pain, anxiety, and muscle stiffness. These reactions are usually mild and seldom require professional treatment.

Some patients report a short-term reaction right after injecting COPAXONE(R). This reaction can involve flushing (feeling of warmth and/or redness), chest tightness or pain with heart palpitations, anxiety, and trouble breathing. These symptoms generally appear within minutes of an injection, last about 15 minutes, and go away by themselves without further problems.

Teva Neuroscience, Inc. markets COPAXONE(R). COPAXONE(R) is a registered trademark of Teva Pharmaceutical Industries Ltd. Teva Neuroscience, Inc. is a subsidiary of Teva Pharmaceutical Industries Ltd.

Call 1-800-887-8100 or log on to http://www.copaxone.com for more information about COPAXONE(R), Team COPAXONE(R), or multiple sclerosis. See additional important information at http://www.copaxone.com/pi/index.html or call 1-800-887-8100 for electronic releases. For hard copy releases, please see enclosed full prescribing information.

References:

1. Bornstein MB, Miller A, Slagle S, et al. N Engl J Med. 1987; 317:408- 414.

2. Johnson KP, Brooks BR, Cohen JA, et al. Neurology. 1995; 45:1268-1276.

3. Comi G, Filippi M, Wolinsky JS, et al. Ann Neurol. 2001; 49:290-297.

4. Goodin DS, Frohman EM, Garmany GP, et al. Neurology. 2002; 58(2 of 2):169-178.

5. Ford C, Johnson K, Brooks B, et al. September 17-20, 2003; Milan, Italy. Abstract and Poster

6. Neuhaus O, Farina C, Wekerle H, et al. Neurology. 2001; 56:702-708.

7. About COPAXONE(R). Available at: http://mswatch.com/therapy/section.aspx?SectionID . Accessed October 11, 2004.

8. Khan OA, Tselis AC, Kamholz JA, et al. Multiple Sclerosis. 2001;7:349- 353.

9. Haas J. Neurology. 2003; 60 (suppl 1):A480. Abstract P06.105.

10. Carra A, Tajer C, Onaha P, et al. Eur J Neurology. 2003;10:671-676.

11. Miller A, Shapiro S, Gershtein R, et al. J Neuroimmunol. 1998; 92:113- 121.

12. Mancardi GL, Sardanelli F, Parodi RC, et al. Neurology. 1998;50:1127- 1133.

Teva Neuroscience, Inc.
http://www.copaxone.com

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