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    Copaxone®

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    Glatiramer acetate (Copaxone) induced hepatotoxicity

    CopaxoneAbstract
    Introduction: Glatiramer acetate (Copaxone), a polypeptide has been approved for treating patients with active relapsing-remitting multiple sclerosis.

    Case Presentation: We report the first case of severe acute hepatitis after commencing treatment for multiple sclerosis with glatiramer acetate.

    A 31-year-old female with multiple sclerosis presented with anorexia, lethargy and jaundice five weeks after commencing glatiramer acetate. She had never received beta-interferon treatment. Investigations revealed a bilirubin of 0.109 mmol/L (0.002-0.02 mmoL/L) and prothrombin time of 21 secs (9-15 secs). Her liver function tests were normal before commencing glatiramer acetate.

    A liver biopsy performed approximately 6 weeks after commencement of glatiramer acetate showed predominantly centrilobular hepatocyte necrosis with portal-venous bridging, along with mild portal and interface hepatitis. The necrosis was not accompanied by an acute inflammatory or chronic inflammatory infiltrate.

    The features were not suggestive of autoimmune hepatitis but consistent with drug toxicity. The liver tests returned to normal within 2 months after cessation of glatiramer acetate.

    Conclusion: Physicians should be aware that glatiramer acetate can be associated with uncommon but yet significantly severe liver toxicity.

    Source: Pubmed PMID: 22873505 (10/08/12)

    US court upholds patents on MS drug Copaxone

    CopaxoneA federal court upheld Teva Pharmaceutical Industries Ltd.'s patents on its multiple-sclerosis drug Copaxone, helping the generic drug giant to beat back threats to its top-selling drug from rivals Mylan Inc. and Momenta Pharmaceuticals Inc.

    The dispute put Teva--the world's biggest manufacturer of generic drugs--in the unusual position of defending against some of the same arguments it has made against other branded drugs in previous patent battles.

    By seeking to cast Teva's claims to its branded drug as "invalid and unenforceable," rivals Mylan and Momenta employed a well-trodden tactic of Teva itself.

    A U.S. district court in New York rejected those claims, however, ruling Friday that generic versions of Copaxone being separately developed by Mylan and Momenta infringe upon Teva's claims to the drug.

    Executives at Mylan and Momenta voiced disagreement with the ruling and pointed to possible appeals.

    "Mylan is disappointed in the Court's decision, and while we have not yet had the opportunity to review the Court's opinion, we fully intend to evaluate our options for an appeal once the Court's full opinion becomes available," Mylan Chief Executive Heather Bresch said in a statement.

    Analysts weighing in on the ruling said a generic threat to Copaxone now appears off the table until Teva's patents on the drug begin to expire in mid-2014.

    "The decision is clearly a huge sigh of relief for Teva," Needham analysts wrote in a note to clients. "This decision significantly de-risks the story over the intermediate term, removes a huge overhang and arguably eliminates the biggest reason to not own shares."

    The investment firm also cast doubt on the potential for successful appeals of Friday's ruling. "It is difficult to envision an appellate court overturning lower court rulings on all patents," analysts wrote.

    Source: Fox Business ©2012 FOX News Network, LLC (26/06/12)

    Top-line results from GALA phase III trial of Copaxone

    CopaxoneTeva Pharmaceutical Industries Ltd. announced positive top-line results from the GALA (Glatiramer Acetate Low-Frequency Administration) Phase III clinical trial assessing the efficacy, safety and tolerability of 40 mg/1 ml glatiramer acetate injection (GA) administered subcutaneously three times a week compared to placebo in relapsing-remitting multiple sclerosis (RRMS) patients. Study results showed that GA 40 mg/1 ml significantly reduced disease activity, while maintaining a favorable safety and tolerability profile.

    The one-year randomized, double-blind placebo-controlled study recruited more than 1,400 patients at 155 multinational sites. Results showed that GA 40 mg/1 ml met the study's primary endpoint by significantly reducing the annualized relapse rate (ARR) by 34.4 percent compared to placebo (p<0.0001). Initial analysis of the data indicates that secondary clinical endpoints were achieved, with the exception of reduction in brain atrophy. Following the initial 12-month, placebo-controlled phase, there will be an ongoing open-label extension of the trial.

    “We are pleased with the results of this study that show the potential of 40 mg/1 ml glatiramer acetate to offer patients an effective and safe treatment option with Copaxone® using a more convenient dosing regimen” said Serge Stankovic, Senior Vice President of Clinical Research, Global Branded R&D, Teva Pharmaceutical Industries Ltd. “We remain focused on the continued research and development of products aimed at improving the treatment experience for patients with MS.”

    Further analyses of the GALA study data are ongoing, and detailed results will be presented to the scientific community in the near future. Teva plans to work with health authorities to determine next steps.

    The most commonly reported adverse events in the study were injection site reactions, headaches and nasopharyngitis. The overall frequencies of adverse events were comparable to those observed in the placebo group.

    ABOUT THE STUDY

    The multinational Phase III Glatiramer Acetate Low-frequency Administration (GALA) trial was designed to examine the safety, efficacy and tolerability of glatiramer acetate (GA) 40 mg/1 ml injection administered three times a week compared to placebo in a randomized double-blind placebo-controlled design in patients with relapsing-remitting multiple sclerosis. The 40 mg/1 ml dose is higher than the currently marketed 20 mg/1 ml daily Copaxone® (glatiramer acetate injection). The primary endpoint of the study is the total number of confirmed relapses during a 12-month, placebo-controlled phase.

    Source: Therapeutics Daily ©2011 UBM Canon (15/06/12)

    Preliminary data suggest spasticity may be reduced in RRMS patients who transitioned to Copaxone

    CopaxoneTeva Pharmaceutical Industries Ltd. announced interim data from a prospective, open label survey study evaluating spasticity in patients with relapsing-remitting multiple sclerosis (RRMS) who transitioned to Copaxone® (glatiramer acetate injection) from interferon-beta treatment. These data were presented today at the 64th Annual Meeting of the American Academy of Neurology (AAN) in New Orleans, Louisiana.

    Interim results for the first 52 of 110 participants revealed a significant reduction in muscle stiffness, pain and discomfort, as well as the effect of spasticity on the ability to walk, body movements and activities of daily living (ADLs). Improvement was also found in reduction of total spasticity scores during the six month period.

    “Spasticity, one of the more common symptoms of RRMS, can often negatively impact patients' daily lives,” said Cira Fraser PhD, RN, ACNS-BC, Associate Professor and Graduate Faculty, Marjorie K. Unterberg School of Nursing and Health Studies, Monmouth University, West Long Branch, New Jersey and Principal Investigator of the study. “These data may suggest a reduction in the key measures of spasticity in RRMS patients who discontinued interferon-beta treatment and transitioned to Copaxone®.”

    The prospective longitudinal survey research study is evaluating 110 participants utilizing the Multiple Sclerosis Spasticity Scale (MSSS-88), the Performance Scales, and a socio demographic questionnaire completed when transitioning between treatments and at month six. Study criteria included participants who had stopped interferon-beta treatment within 30 days; were about to start, or started Copaxone® within the previous 21 days; had spasticity; and were able to ambulate with unilateral support or without. Of the 52 participants, whose data are currently being reported, 35 percent were taking medication for spasticity prior to enrollment and during the six month period.

    “These study results contribute to the body of knowledge on the treatment of RRMS,” said Jon Congleton, Teva's Senior Vice President, Global Brand Strategic Marketing. “Through the ongoing support of research such as this, Teva is continually working to help improve the lives of RRMS patients.”

    ABOUT THE STUDY

    [P07.074] A Prospective Study of Spasticity in Individuals with Multiple Sclerosis (MS) in Transition from Interferon-Beta to Glatiramer Acetate (Session P07: Multiple Sclerosis: Symptoms, April 26 at 2:00 PM) Cira J. Fraser, West Long Branch, NJ

    Source: Drugs.com Copyright © 2000-2012 Drugs.com (27/04/12)

    Glatiramer-IFN combination in MS bring mixed results

    Disease Modifying DrugsRadiologic findings from a closely watched trial of glatiramer acetate (Copaxone) and interferon-beta-1a (Avonex) combination therapy in relapsing remitting multiple sclerosis were mixed, a researcher said here.

    Compared with the individual drugs given alone for 3 years, the combination was superior in terms of new lesion activity visible on MRI scans and in the accumulation of total lesion volumes, said Jerry Wolinsky, MD, of the University of Texas Health Science Center in Houston.

    But the combination failed to show an advantage over monotherapy in several other key radiological measures, including brain atrophy, volume of normal-appearing grey and white matter, and the so-called Z4 composite score, Wolinsky told attendees at the American Academy of Neurology meeting.

    Clinical results from the CombiRx trial -- which Wolinsky described as "the longest controlled clinical, MRI, and biomarker dataset of any MS trial" -- are to be reported Friday. Unlike most presentations at the meeting, the published abstract contained no information on results.

    Glatiramer acetate and interferon-beta have been the mainstays of multiple sclerosis treatment for many years. Although most patients eventually relapse or progress while taking one of these agents, they usually switch treatments rather than add the other one.

    Session moderator Robert Fox, MD, of the Cleveland Clinic, told MedPage Today that combination treatment is unusual -- for one thing, because the drugs are expensive and insurance seldom pays for both at once.

    With little experience, clinicians have not really known whether combining the two drugs would even be helpful, Fox said.

    The CombiRx trial, funded by the National Institutes of Health, started in 2005, Wolinsky said. A total of 1,008 patients were enrolled through April 2009, with 3-year data finally locked earlier this month.

    Patients were randomized to the three study arms in a 2:1:1 ratio to the combination or to one drug or the other as monotherapy, with a placebo-controlled, double-dummy, and double-blinded design.

    Mean patient age was about 38, with an average disease duration of 4.3 years and just over a year after diagnosis when they enrolled in the study.

    About 40% of patients showed gadolinium-enhancing lesions at enrollment. The average count at baseline was 1.7, with total lesion volume of 12.2 mL and a T1 hypointense lesion volume of 1.7 mL.

    Relative to baseline, patients in all three arms showed improvement on average in each of the major radiologic evaluations. But there was no clear winner among treatments, as Wolinsky explained. For the combination to be considered effective, it had to be significantly superior to the most effective of the monotherapy treatments, and that was mostly not the case.

    The broadest measure was the Z4 composite, which combined MRI measures of gadolinium-enhancing, T1 hypointense, and T2 hyperintense lesions and normalized cerebrospinal fluid volume. There was no significant difference during the trial between the combination and either of the two monotherapies.

    Combination treatment also failed to be clearly superior in several other measures: total gadolinium-enhancing lesion volume over time, the percent of patients free of gadolinium-enhancing lesions at 36 months, total burden of disease, "combined unique activity lesions," total T1 hypointense lesion volume, or intracranial cerebrospinal fluid volume (reflecting brain atrophy).

    As would be expected from a combination of two drugs known to be active against MS lesion activity, it was never the case that the combination was inferior to a monotherapy.

    On the other hand, there was little to suggest that their effects were additive.

    Fox told MedPage Today that it was too early to call the combination a failure. "We'll have to see the clinical results," he said.

    The trial was funded by the National Institutes of Health. Teva and Biogen Idec provided study medications free of charge.

    Wolinsky reported personal payments from Astellas, Bayer, Celgene, Eli Lilly, Roche, Novartis, sanofi-aventis, Teva Neuroscience as consultant and participant on monitoring and advisory boards, and research support from sanofi-aventis.

    Fox reported payments from Avanir, Biogen Idec, EMD Serono, and Novartis, and research support from Biogen Idec and Genentech.

    Primary source: American Academy of Neurology

    Source reference:
    Wolinsky J, et al "The CombiRx trial: A multi-center, double-blind, randomized study comparing the combined use of interferon beta-1a and glatiramer acetate to either agent alone in participants with relapsing remitting multiple sclerosis – MRI outcomes" AAN 2012; Abstract S10.002.

    Source: MedPage Today © 2012 Everyday Health, Inc (26/04/12)

    Teva sues Synthon over generic Multiple Sclerosis drug

    CopaxoneTeva Pharmaceutical Industries Ltd. (TEVA) sued Synthon BV for infringing seven patents in planning to sell a generic version of the multiple sclerosis drug Copaxone before Teva’s patents expire.

    Teva, based in Petach Tikva, Israel, said it licensed the patents from Yeda Research & Development Co., according to the lawsuit filed yesterday in federal court in New York.

    Copaxone, used to reduce the frequency of relapses in multiple sclerosis patients, generated sales (TEVA) of $3.9 billion in 2011. Synthon filed an application with the U.S. Food and Drug Administration seeking approval of a generic version of the drug, according to the complaint.

    “Defendants plan to begin manufacturing, marketing, selling, offering to sell and/or importing Synthon’s generic glatiramer acetate product soon after FDA approval,” Teva said in the complaint. “Such conduct will constitute direct infringement.”

    Closely held Synthon, based in Nijmegen, Netherlands, filed a document with the FDA stating that Teva’s patent claims are invalid or unenforceable and that Synthon’s drug wouldn’t infringe them, Teva said.

    Fabienne Douven, a Synthon spokeswoman, said in an e-mail that the company would fight the suit.

    ‘Affordable and Accessible’

    “We are committed to developing a generic alternative to Copaxone, to make this RRMS treatment, with a current high cost of around $40,000 per year for U.S. patients, more affordable and accessible,” she said, referring to relapsing-remitting multiple sclerosis.

    Teva has also sued Sandoz AG and other drug companies over Copaxone.

    Yeda Research, based in Rehovot, Israel, markets and licenses developments from the laboratories at the Weizman Institute of Science, according to the complaint.

    The case is Teva Pharmaceuticals USA Inc. v. Synthon Pharmaceuticals Inc., 12-2556, U.S. District Court, Southern District of New York (Manhattan).

    Source: Bloomberg COPYRIGHT 2012 BLOOMBERG L.P. (05/04/12)

    Teva sanctioned by FDA for false Copaxone promotion

    Copaxone Nothing like a little exaggeration to quickly attract the wrath of the FDA. And this is what Teva Pharmaceuticals did with both a panel display at the recent American Academy of Neurology about its Copaxone multiple sclerosis treatment and a ‘Team Copaxone’ web site that the drugmaker designed to promote the medication (here is the website).

    In a letter last week the FDA Office of Prescription Drug Promotion scolded Teva for developing materials that were false and misleading, causing “violations (that) are concerning from a public health perspective, because they suggest that Copaxone is safer or more effective than has been demonstrated by substantial evidence or substantial clinical experience.”

    To wit, the panel that Teva displayed at the AAN meeting boasted that Copaxone, which is approved for reducing the frequency of relapses in patients with Relapsing-Remitting Multiple Sclerosis, has demonstrated 20 years of proven safety, show results after an average of 22 years with RRMS, and that Expanded Disability Status Scale scores remained stable after an average of 15 years on therapy.

    But there was a problem - the FDA noted the claims “misleadingly overstate the safety and efficacy” because the clinical studies section of the product labeling “only includes data for up to three years in duration.” Meanwhile, the AAN exhibit panels refer to open-label extension studies, but neither of these “constitute substantial evidence to support” the claims, the FDA wrote.

    The agency also expressed concern that the AAN panel suggested Copaxone is safer and more effective than other meds because no initial routine monitoring is required or recommended, but the drugmaker does not have head-to-head data to support the contention.

    There was more. The Teva web site cites patients named David Kyle and Karen Stewart, both of whom showed impressive improvements in functioning after being treated with Copaxone. But the claims were considered misleading by implying the drug reverses disability and enables patients to lead active lifestyles, return to work, accomplish great athletic feats and “live the life they’ve dreamed.”

    For instance, before treatment, “Karen Stewart” was constantly feeling fatigue, was unable to walk unassisted, and was forced to leave her job. After treatment, she returned to work as a nurse and walked 22 marathons. As for “David Kyle,” he was partially paralyzed and barely had enough energy to work half a day prior to Copaxone, the FDA notes. After Copaxone, he was able to compete and win national and international triathlons for the physically challenged.

    “While these statements may be an accurate reflection of these patient experiences, the patient testimonials misleadingly broaden the indication and overstate the efficacy of Copaxone. As described in the Background section, Copaxone has demonstrated efficacy in decreasing the frequency of relapses in patients with RRMS. However, Copaxone is not indicated for slowing, preventing or reversing physical disability associated with RRMS,” the FDA warns Teva.

    The overall impression troubled the FDA, because the agency believes the web sites suggest the drug is approved to treat all types of MS, but is not approved for slowing the progression of disability of the disease. Compounding the problem - the web sites failed to include any risk info in the body of the web pages. There are links to important safety info and the product labeling, but “these links do not mitigate the misleading omission of risk information from the body of each of these webpages.”

    Here is the FDA letter.

    A Teva spokeswoman writes us to say that the drugmaker is “are evaluating our materials related to the areas of concerns raised by FDA. We remain committed to ensuring we comply with all FDA regulations and guidelines.”

    Source: Pharmalot © 2012 UBM Canon Pharmaceutical Media Group (26/03/12)

    Copaxone appears to repair nerve tissue in MS patients

    CopaxoneCopaxone repairs nerve tissue in multiple sclerosis patients, said Teva Pharmaceutical Industries Ltd. in reporting the results of a 12-month MRI study on the evolution of multiple sclerosis lesions. The study was published in the January issue of "Frontiers in Bioscience".

    “These data indicate that treatment with Copaxone resulted in a measureable amount of tissue repair in study patients,” said the lead research Dr. Robert Zivadinov, Director of the Buffalo Neuroimaging Analysis Center at the University at Buffalo. “The observed increases in magnetization transfer ratio (MTR) point to a potential for remyelination.

    Overall, these findings contribute to the vast body of research that supports the long-term efficacy and safety of the therapy."

    The researchers found that multiple sclerosis patients treated with Copaxone experienced significantly increased magnetization transfer ratio (MTR) - a nonconventional MRI technique used to investigate abnormalities in brain structures, and increased values indicate potential remyelination (re-generation of the nerve's myelin sheath) and axonal tissue repair in the patients' brains.

    Teva added that this was the first study to evaluate multiple sclerosis lesions as potential evidence for remyelination in patients treated with Copaxone.

    Source: Globes Online © Globes.All rights reserved (04/01/12)

    Higher patient adherence to disease modifying therapies reduces MS costs

    Disease Modifying DrugsAvi Dor, Ph.D., professor in the Department of Health Policy, GW School of Public Health and Health Services, was a co-author of a study, in collaboration with Teva Pharmaceuticals, that found that higher patient adherence to disease modifying therapies, like glatiramer acetate (GA), an immunomodulator drug currently used to treat multiple sclerosis, reduced inpatient costs, outpatient costs, and other medical expenses in a national sample of multiple sclerosis patients.

    This research was published in the December issue of the Journal of Medical Economics.

    "The results suggest that by improving patient adherence to medications, for chronic diseases, like GA for multiple sclerosis, overall costs of treatment costs can be reduced" said Dr. Dor.

    "This research underscores the need to develop policies to encourage medication compliance. Such policies will lead to cost savings through the health care system in the long run."

    Results suggest that, despite higher costs associated with increased usage of GA, relapses of symptoms associated with MS are reduced, and other medical costs for MS patients are offset with adherent use.

    Source: Medical News Today © MediLexicon International Ltd 2004-2011 (30/11/11)

    Glatiramer acetate better than Interferon for MS fatigue

    FatigueGlatiramer acetate (GA) reduces fatigue in multiple sclerosis patients more than interferon beta-1b (IFN-1b) after 1 year of treatment, according to a new study.

    IFN-1b had no impact on two clinical measures of fatigue, while GA (Copaxone) reduced the score on the Fatigue Severity Scale (FSS) by 20%, and the score on the Fatigue Descriptive Scale (FDS) by 34%, according to a study presented here at the European Committee for Treatment and Research in Multiple Sclerosis meeting.

    Based on the results, the authors, Tatiana Shmidt and a colleague at the Kozhevnikov Clinic for Neurological Diseases in Moscow, Russia, concluded in their poster, "Copaxone is recommended as a first-line imunomodulating drug for patients with severe fatigue." The authors were unavailable for comment at press time.

    While fatigue may be a significant symptom in multiple sclerosis (MS), "the impact of immunomodulatory drugs on fatigue has not been extensively investigated," they wrote. So the authors compared GA, IFN-1b, and no treatment in patients with severe fatigue in a clinical study, supplemented by a laboratory study to find biomarkers for fatigue reduction.

    They enrolled 63 patients with relapsing-remitting MS who had FSS scores of at least 4. The FSS is a 9-item scale assessing the impact of fatigue on daily living, with a minimum score of 1 and a maximum of 9. An FSS score greater than 4 indicates severe fatigue.

    Patients received either GA (n=27), IFN-1b (n=19), or no immunomodulatory treatment (n=17), and were followed for 1 year.

    At the end of the year, FSS score in GA-treated patients had fallen (improved) from 4.5 to 3.61 (P<0.01), while there was no significant change in patients receiving IFN-1b. Scores in untreated patients rose from 4.48 to 4.82 (P<0.05).

    Scores on the FDS, an alternative measure of fatigue severity, fell (improved) from 7.26 to 4.78 for GA-treated patients (P<0.01), remained unchanged in IFN-1b-treated patients, and rose from 6.92 to 8 in untreated patients (P<0.05).

    A similar pattern was seen for measures of cognitive fatigue and the Fatigue Impact Scale.

    Patients in the GA-treated group had a "trend to reduced IL-6 and to increased vanillylmandelic acid and homovanillic acid," which, the authors concluded, "may be suggested as presumable markers of fatigue in relapsing-remitting MS." Data for these biochemical changes were not presented in the poster session.

    "The positive impact of this drug on fatigue in relapsing-remitting MS is possibly associated with its double mechanism of action," they said, involving both anti-inflammatory and neuroprotective components.

    Primary source: European Committee for Treatment and Research in Multiple Sclerosis

    Source reference:
    Shmidt T, et al "The impact of immunomodulators on fatigue in relapsing-remitting multiple sclerosis" ECTRIMS 2010; Abstract #818.

    Source: Medpage Today © 2011 Everyday Health, Inc (20/10/11)

    Copaxone demonstrates remyelination and neuroprotective effects

    CopaxoneTeva Pharmaceutical Industries Ltd. today announced preclinical data demonstrating reparative and neuroprotective effects of treatment with Copaxone(R) (glatiramer acetate injection) in experimental autoimmune encephalomyelitis (EAE) models. In the study, researchers compared mice treated with Copaxone(R) versus non-treated mice in relapsing-remitting and chronic multiple sclerosis (MS) disease models. Researchers observed both remyelination indicative of repair and a drastic reduction of demyelination and axonal loss in mice treated with Copaxone(R).

    "While several previous studies, both clinical and preclinical, pointed to possible neuroprotective properties of Copaxone(R) treatment, these data demonstrate a process of remyelination as a consequence of the treatment," said lead study author, Rina Aharoni, Senior Staff Scientist, Department of Immunology, The Weizmann Institute of Science, Rehovot, Israel. "These data may also help explain why Copaxone(R) continues to demonstrate efficacy in the long-term."

    In addition to remyelination and neuronal preservation, the central nervous system of mice treated with Copaxone(R) had smaller lesions, increased axonal density and a higher prevalence of normal appearing axons. Measurements were taken both before and after induction of EAE, showing that Copaxone(R) prevented new damage and caused reversal of existing neurological degeneration. These data will be published this fall in the Journal of Autoimmunity.

    A second preclinical study demonstrated that a signaling pathway for Copaxone(R) deactivated white blood cells called macrophages that induce inflammation and autoimmune response.

    "Data have indicated that activated damaging macrophages may contribute to axonal loss in MS, and that the deactivation of these macrophages may be a therapeutic goal of treatment," said lead study author, Nicolas Molnarfi, Researcher Neuroimmunologist, Department of Neurology and Program in Immunology, University of California, San Francisco, California. "These data showed that Copaxone(R) deactivated specific macrophages, elucidating a potential mechanism for the impact of Copaxone(R) treatment."

    The results of both studies will be presented on October 20, 2011 at the Fifth Joint Triennial Congress of the European and Americas Committees for Treatment and Research in Multiple Sclerosis (ECTRIMS and ACTRIMS).

    About the Studies:

    In the study evaluating potential neuroprotective effects of Copaxone(R), the in situ pathological manifestations of two different EAE models, the relapsing-remitting PLP-induced and the chronic MOG-induced diseases were analyzed and compared, utilizing both transmission electron microscopy (TEM) and immunohistochemistry. The effect of the MS drug Copaxone(R) on myelin damage/repair and on motor neuron loss/preservation was studied in both models.

    Quantitative TEM analysis of the relative remyelination extent, compared to demyelination, provides, for the first time, evidence of significant augmentation of remyelination after treatment with Copaxone(R) (glatiramer acetate injection). Loss of motor neuron was also reduced in mice treated with Copaxone(R), in comparison to that of EAE untreated mice. These effects were obtained even when Copaxone(R) treatment was applied in a therapeutic schedule, after the appearance of clinical symptoms.

    In the study evaluating the anti-inflammatory mechanism of Copaxone(R), exposure of murine macrophages to Copaxone(R) induces phosphoinositide 3-kinase (PI3K) activation, a central negative regulator in inflammation. The results provide a direct mechanism of inhibition of innate signals by Copaxone(R) and delineate a signaling pathway important for deactivation of macrophages in inflammation and autoimmunity.

    Source: Teva Pharmaceutical Industries Ltd (20/10/11)

    Significant reduced loss of brain volume in MS patients treated with Copaxone

    CopaxoneResults from a five-year study of treatment-naïve patients with relapsing-remitting multiple sclerosis (RRMS) demonstrated that patients treated with Copaxone (glatiramer acetate injection) showed significant reduced loss of brain volume compared to patients treated with other disease modifying therapies (DMTs).

    Though all DMT treatment arms resulted in a reduction in brain volume loss compared to the control group of non-treated patients, Copaxone had a significantly better effect than both low and high dose interferons, in reducing loss of brain volume. A paper published by Dr. Omar Khan, detailing the study findings, "Effect of disease-modifying therapies on brain volume in relapsing-remitting multiple sclerosis: Results of a five-year brain MRI study," was recently published in the Journal of the Neurological Sciences.

    "These data represent the importance of ongoing research in a practical clinical setting to better understand multiple sclerosis and the impact of therapy on the course of the disease ," said Jon Congleton, Senior Vice President and General Manager, Teva Neuroscience. "Not only does this study highlight the benefit of Copaxone in reducing brain volume loss, it underscores the value of early treatment in influencing long-term outcomes."

    Brain volume loss in multiple sclerosis patients exceeds the rate of healthy control groups. Brain volume loss, sometimes referred to as atrophy, may be correlated with cognitive and physical deficits. Modern magnetic resonance (MR) techniques can reliably measure loss of brain volume over time.

    About the Study

    In the study, the Copaxone treatment arm resulted in a -2.27 percent change in brain volume (PCVB) as compared to baseline versus -2.62 percent for Avonex (low-dose interferon), -3.21 percent for Betaseron/Rebif (high-dose interferon).

    This was a retrospective study in which the brain magnetic resonance imaging (MRI) scans of 275 RRMS patients treated with DMTs were examined with Structural Image Evaluation, using Normalization of Atrophy (SIENA). Data analysis was conducted in 2007-08 and the study period included patients who started DMTs in 2001-02 and subsequently received the same DMT for five years. Inclusion criteria for the study were diagnosis of clinically definite RRMS, disease duration of five years or less at the time of initiating DMT and treatment-naïve prior to initiation of DMT at onset of study observation period.

    Untreated RRMS patients with follow-up ranging from eight to 24 months were enrolled as controls. All untreated patients also had prior brain MRI scans on no therapy that could be analyzed with SIENA, so that their rate of brain volume loss was annualized and then projected over five years assuming a constant rate of brain volume loss over five years.

    121 patients in the study were treated with Copaxone, 101 were treated with Betaseron or Rebif and 53 were treated with Avonex. All patients had brain MRI scans (at onset of DMT and five years later) on the same 1.5T scanner. Image analysis was performed blinded to treatment allocation.

    The study was supported by Wayne State University Neuroscience Program. Preliminary results from this study were presented at the American Academy of Neurology annual meeting in 2008.

    Source: Teva Pharmaceutical Industries Ltd. (12/10/11)

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