Twenty-Six Year Data With COPAXONE
Posted: Mon Oct 03, 2005 6:51 am
An interesting long term study. This is the same post as before... I just wanted to include the text just in case the link went down.
Twenty-Six Year Data With COPAXONE(R) Reinforce Clinical Efficacy and Safety in Relapsing-Remitting Multiple Sclerosis
Monday October 3, 8:00 am ET
Study Represents Extensive, Continuous Clinical Experience With Immune Modulating Therapy
KANSAS CITY, MO--(MARKET WIRE)--Oct 3, 2005 -- Clinical experience and study data with COPAXONE® (glatiramer acetate injection) in relapsing-remitting multiple sclerosis (RRMS) patients with active disease (mean annual relapse rate of 2.9) now span more than a quarter of a century. In a long-term, open-label, compassionate use study of up to 26 years (prior to any immune modulating therapies approved by the Food and Drug Administration (FDA)), presented at the 21st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), clinical efficacy and safety data demonstrated reductions in relapse rates, slowed disease progression, and continued tolerability of COPAXONE®.
"To see the long-term positive impact on disease progression in these patients on COPAXONE® is very helpful for clinicians and patients making treatment decisions, especially since long-term data with other therapies are scarce," said Dr. Aaron Miller, professor of neurology, Department of Neurology, Mount Sinai School of Medicine, New York, and lead investigator on the study. "Long-term data reinforcing the clinical utility, such as this experience with COPAXONE®, can be reassuring for patients and physicians when making treatment choices."
The author reported the long-term clinical experience in 46 RRMS patients treated with COPAXONE® for 1-26 years (average 10.5 years). Assessment of clinical effectiveness included annual relapse rates and Extended Disability Status Scale (EDSS) scores.
Safety was determined by reports of adverse effects. Patients were seen every six months. Of the original 46 patients, 18 remain active in the study, and of the 28 who withdrew, patient decision to withdraw was the most common reason (54 percent).
At entry, based on a patient's entire history, mean annual relapse rate was 2.9+/-1.4 (range: 1-7). At last clinical observation, mean annual relapse rate for 24 of 42 patients on COPAXONE® (glatiramer acetate injection) was reduced (0.1+/-0.2, p < 0.0001). In terms of EDSS, 24 of 42 (57%) patients had improved or unchanged EDSS scores at last observation compared to pretreatment entry of 3.0+/-1.8 (range: 0-6.5). Over the long course of the study, a non-significant change in average EDSS score was observed (3.0+/-1.8 at entry vs. 3.8+/-2.5 at last observation). Only 8 of 34 (23.5 %) patients with entry EDSS scores less than six, progressed to an EDSS score of six or more with average disease duration of greater than 17 years. For those patients remaining in the study (at the time of data cut-off for this abstract, n=18) with average disease duration greater than 24 years, only 26.7 percent progressed to EDSS greater than or equal to six. This compares favorably to a natural history cohort, which shows 50 percent progressing to six or greater at 15 years after disease onset. Long-term COPAXONE® therapy was well tolerated, and patients reported adverse events similar to those experienced in short-term trials.
About COPAXONE®
Current data suggest COPAXONE® is a selective MHC class II modulator. COPAXONE® is indicated for the reduction of the frequency of relapses in relapsing-remitting multiple sclerosis. The most common side effects of COPAXONE® are redness, pain, swelling, itching, or a lump at the site of injection, weakness, infection, pain, nausea, joint pain, anxiety, and muscle stiffness.
COPAXONE® (glatiramer acetate injection) is now approved in 44 countries worldwide, including the United States, Canada, Mexico, Australia, Israel, and all European countries. In Europe, COPAXONE® is marketed by Teva Pharmaceutical Industries Ltd. and sanofi-aventis. In North America, COPAXONE® is marketed by Teva Neuroscience.
Teva Pharmaceutical Industries Ltd. (NasdaqNM:TEVA - News), 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®. COPAXONE® 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 beliefs and expectations of Teva's 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 whether and when the proposed acquisition with Ivax Corporation will be consummated and the terms of any conditions imposed in connection with such closing, the terms and conditions of the financing utilized by Teva for the Ivax acquisition, Teva's ability to rapidly integrate Ivax'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 version of Neurontin®, the effects of competition on Copaxone® 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.
05270508/050970
Contact:
Contacts:
John Shaw
Teva Neuroscience
(816) 508-5062
Email Contact
Mandy Levings
Fleishman-Hillard
(816) 512-2379
Email Contact
Source: Teva Pharmaceutical Industries Ltd.
Orig Link:
http://biz.yahoo.com/iw/051003/096732.html
Twenty-Six Year Data With COPAXONE(R) Reinforce Clinical Efficacy and Safety in Relapsing-Remitting Multiple Sclerosis
Monday October 3, 8:00 am ET
Study Represents Extensive, Continuous Clinical Experience With Immune Modulating Therapy
KANSAS CITY, MO--(MARKET WIRE)--Oct 3, 2005 -- Clinical experience and study data with COPAXONE® (glatiramer acetate injection) in relapsing-remitting multiple sclerosis (RRMS) patients with active disease (mean annual relapse rate of 2.9) now span more than a quarter of a century. In a long-term, open-label, compassionate use study of up to 26 years (prior to any immune modulating therapies approved by the Food and Drug Administration (FDA)), presented at the 21st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), clinical efficacy and safety data demonstrated reductions in relapse rates, slowed disease progression, and continued tolerability of COPAXONE®.
"To see the long-term positive impact on disease progression in these patients on COPAXONE® is very helpful for clinicians and patients making treatment decisions, especially since long-term data with other therapies are scarce," said Dr. Aaron Miller, professor of neurology, Department of Neurology, Mount Sinai School of Medicine, New York, and lead investigator on the study. "Long-term data reinforcing the clinical utility, such as this experience with COPAXONE®, can be reassuring for patients and physicians when making treatment choices."
The author reported the long-term clinical experience in 46 RRMS patients treated with COPAXONE® for 1-26 years (average 10.5 years). Assessment of clinical effectiveness included annual relapse rates and Extended Disability Status Scale (EDSS) scores.
Safety was determined by reports of adverse effects. Patients were seen every six months. Of the original 46 patients, 18 remain active in the study, and of the 28 who withdrew, patient decision to withdraw was the most common reason (54 percent).
At entry, based on a patient's entire history, mean annual relapse rate was 2.9+/-1.4 (range: 1-7). At last clinical observation, mean annual relapse rate for 24 of 42 patients on COPAXONE® (glatiramer acetate injection) was reduced (0.1+/-0.2, p < 0.0001). In terms of EDSS, 24 of 42 (57%) patients had improved or unchanged EDSS scores at last observation compared to pretreatment entry of 3.0+/-1.8 (range: 0-6.5). Over the long course of the study, a non-significant change in average EDSS score was observed (3.0+/-1.8 at entry vs. 3.8+/-2.5 at last observation). Only 8 of 34 (23.5 %) patients with entry EDSS scores less than six, progressed to an EDSS score of six or more with average disease duration of greater than 17 years. For those patients remaining in the study (at the time of data cut-off for this abstract, n=18) with average disease duration greater than 24 years, only 26.7 percent progressed to EDSS greater than or equal to six. This compares favorably to a natural history cohort, which shows 50 percent progressing to six or greater at 15 years after disease onset. Long-term COPAXONE® therapy was well tolerated, and patients reported adverse events similar to those experienced in short-term trials.
About COPAXONE®
Current data suggest COPAXONE® is a selective MHC class II modulator. COPAXONE® is indicated for the reduction of the frequency of relapses in relapsing-remitting multiple sclerosis. The most common side effects of COPAXONE® are redness, pain, swelling, itching, or a lump at the site of injection, weakness, infection, pain, nausea, joint pain, anxiety, and muscle stiffness.
COPAXONE® (glatiramer acetate injection) is now approved in 44 countries worldwide, including the United States, Canada, Mexico, Australia, Israel, and all European countries. In Europe, COPAXONE® is marketed by Teva Pharmaceutical Industries Ltd. and sanofi-aventis. In North America, COPAXONE® is marketed by Teva Neuroscience.
Teva Pharmaceutical Industries Ltd. (NasdaqNM:TEVA - News), 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®. COPAXONE® 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 beliefs and expectations of Teva's 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 whether and when the proposed acquisition with Ivax Corporation will be consummated and the terms of any conditions imposed in connection with such closing, the terms and conditions of the financing utilized by Teva for the Ivax acquisition, Teva's ability to rapidly integrate Ivax'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 version of Neurontin®, the effects of competition on Copaxone® 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.
05270508/050970
Contact:
Contacts:
John Shaw
Teva Neuroscience
(816) 508-5062
Email Contact
Mandy Levings
Fleishman-Hillard
(816) 512-2379
Email Contact
Source: Teva Pharmaceutical Industries Ltd.
Orig Link:
http://biz.yahoo.com/iw/051003/096732.html