The European Commission (EC) fined Teva Pharmaceuticals €462.6 million — more that $502 million — after an investigation it launched found the company illegally tried to stop competitor versions of Copaxone (glatiramer acetate injection), its blockbuster drug for multiple sclerosis (MS), from entering markets. Several patents…

Taking Copaxone (glatiramer acetate), an approved therapy for relapsing forms of multiple sclerosis (MS), while breastfeeding does not appear to be harmful to infants during their first 18 months, according to a real-life study in Germany called COBRA. “In this study, we compared the development of 120 children in total, whose…

The label of Copaxone (glatiramer acetate) — an approved therapy for relapsing forms of multiple sclerosis (MS) — has been updated in Europe to no longer contain a warning against its use during breastfeeding. The label update follows a review by European Union health authorities of non-clinical and clinical evidence submitted…

A higher dose of Copaxone (glatiramer acetate) given three times weekly over seven years led to sustainably lower relapse rates and slowed disability progression in multiple sclerosis (MS) patients, according to a long-term analysis of the GALA study. The higher dose — 40 mg/mL — was generally well-tolerated with no…

A Phase 3 trial investigating GA Depot, a long-acting, once-a-month injectable formulation of glatiramer acetate, is seeking patients with relapsing forms of multiple sclerosis (MS). The global study (NCT04121221) aims to include 960 adults, ages 18 to 55, diagnosed with clinically isolated syndrome (CIS), relapsing-remitting…

Researchers at the Kessler Foundation, with support from Genentech, are opening a study into how Ocrevus (ocrelizumab) affects cognitive fatigue — the feeling of complete exhaustion after focused concentration — in people with relapsing-remitting multiple sclerosis (RRMS). Cognitive fatigue is a frequent problem with MS, reported in…

Almost two-thirds of people newly diagnosed with multiple sclerosis (MS) in the United States, identified through a national database, were not prescribed disease-modifying therapies (DMTs) over an average of more than two years of follow-up, a real-world study of nearly 5,700 patients found. Current guidelines “recommend early treatment with…

Genentech‘s Ocrevus (ocrelizumab) continues to be the most prescribed medication to reduce inflammatory disease in people with active secondary progressive multiple sclerosis (SPMS) among U.S. neurologists, even though Novartis’ Mayzent (siponimod) and EMD Serono’s Mavenclad (cladribine) were approved in March to treat this same MS…

Teva Canada announced that Teva-Fingolimod 0.5 mg capsules, a bioequivalent generic version of Novartis’ Gilenya (fingolimod), are now available in Canada and approved by the country’s national health system called Health Canada. Generic medicines are chemically identical to the original branded therapy, but carry a significantly lower cost. Canadian…

Prescriptions of two multiple sclerosis (MS) treatments —  Merck KGaA‘s Mavenclad (cladribine) and Roche‘s Ocrevus (ocrelizumab) — have been rising in Europe over the past six months, bolstered by greater market access and compassionate use programs, according to a survey of 250 EU neurologists run…

Using newer disease-modifying therapies (DMTs) as an initial treatment for children and adolescents with multiple sclerosis (MS) or clinically isolated syndrome (CIS) is associated with fewer relapses and brain lesions compared to the use of older and injectable DMTs, according to a real-world study in the U.S.

Novartis‘ Gilenya (fingolimod), Sanofi Genzyme‘s Aubagio (teriflunomide), and Biogen’s Tysabri (natalizumab) and Tecfidera (dimethyl fumarate) are the top disease-modifying therapies to which patients with multiple sclerosis (MS) have most frequently switched in…

Treating multiple sclerosis with Tecfidera induces specific genetic alterations that may reduce the levels of immune T-cells targeting the central nervous system, researchers report. Environmental stimuli may induce epigenetic changes in cells — meaning not alterations in the genes themselves, but changes in gene expression (the process by which information in a gene is synthesized to create a working product, like a protein). Epigenetic changes may induce MS development, as these alterations can cause T-cells to attack the central nervous system. One type of epigenetic change is DNA demethylation, the removal of methyl chemical groups, in which molecules involved in metabolism (such as fumarate) interact with enzymes known as DNA demethylases. This process in key for T-cell activation, function and memory, suggesting that it could be an immunomodulatory target. Fumaric acid esters were shown to be effective in MS clinical trials, leading to the approval of Tecfidera (by Biogen) for people with relapsing-remitting forms of the disease. However, their complete mechanism of action remains unclear. Aiming to address this gap, scientists at the Advanced Science Research Center (ASRC) at The Graduate Center of The City University of New York and the Icahn School of Medicine at Mount Sinai, recruited 98 MS patients, either previously untreated (47 people, mean age of 38.4), treated with Tecfidera (35 people, mean age of 42.3), or treated with glatiramer acetate (16 patients, mean age of 43.4) — marketed as Copaxone by Teva Pharmaceuticals, with generic forms by Sandoz (as Glatopa) and by Mylan. All patients had stable disease for at least three months, but disease duration was shortest in untreated patients — 40.4 months vs. 130 months in those given Tecfidera, and 100 months in patients using glatiramer acetate. Blood samples were collected from each participant to assess epigenetic changes in T-cells expressing the cell surface marker CD4. MS patients typically have an activated form of these cells in their blood and cerebrospinal fluid, the liquid surrounding the brain and spinal cord. Results revealed that, compared to the other two groups, treatment with Tecfidera was associated with a lower percentage of T-cells containing the CD3, CD4, and CD8 markers, as well as lower levels of subsets of T-cells expressing the CCR4 and CCR6 receptors, which are critical to T-cell migration to the gut, brain, and skin. Treatment with glatiramer acetate resulted in significantly milder alterations in T-cell percentages compared to no treatment. Researchers then found that FAEs induce excessive methylation — the addition of methyl groups — in T-cells containing CD4, compared to glatiramer acetate. Specifically, this overmethylation was observed in a micro-RNA — tiny RNA molecules than control gene expression — known as miR-21, key for the differentiation of a subset of T-cells called T helper-17 (Th17) cells and for CCR6 expression in MS mouse models. These Th17 cells are critical in tissue inflammation and destruction, and have been implicated in MS. The epigenetic effects of FAEs were subsequently validated by comparing pre- to post-treatment with Tecfidera in seven patients. In turn, in vitro (lab dish) experiments showed that FAEs act specifically on the activation of naïve T-cells — those able to respond to new pathogens to the immune system — containing the CD4 or the CD8 markers. Of note, patients with MS have shown increased miR-21 levels, particularly during acute relapses. As such, the team hypothesized that its hypermethylation by FAEs could contribute to remission and the prevention of relapses in this patient population. These results "suggest that the metabolic-epigenetic interplay in T-cells could be harnessed for therapeutic purposes," the researchers wrote, and that the immunomodulatory effect of FAEs in MS is due at least in part to the epigenetic regulation of T-cells. The researchers believe that their findings have a broader implication, beyond MS. "Our findings about therapeutically active metabolites have implications for the treatment of not only multiple sclerosis but also other autoimmune diseases, such as psoriasis and inflammatory bowel disease, which involve the same type of T-cells," Achilles Ntranos, the study’s lead author, said in a press release. "Understanding the epigenetic effect of metabolites on the immune system will help us develop several novel strategies for the treatment of autoimmune diseases, which could help patients and physicians achieve better clinical outcomes," Ntranos added. Patrizia Casaccia, the study’s senior author, concluded: "It may one day be possible to target and suppress production of the specific brain-homing T-cells that play a role in the development of MS."

Multiple sclerosis (MS) patients given intensive disease-modifying therapies early in their disease course have more favorable long-term outcomes than those treated with an escalating regimen, real-world data shows. The study, “Clinical Outcomes of Escalation vs Early Intensive Disease-Modifying Therapy in Patients With Multiple Sclerosis,” was published in the journal …

The world’s largest generic medicines manufacturer, Teva Pharmaceutical, is at the 31st European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) Congress currently ongoing in Barcelona, from October 7-10, 2015. Teva will be presenting the latest findings on its relapsing multiple sclerosis (MS) therapy COPAXONE® (glatiramer acetate injection), and product candidate for…

According to a press release from Mylan N.V., the U.S. Patent and Trademark Office (PTO) has issued an inter partes review (IPR) proceeding on all claims against a third Copaxone patent for the 40 mg/mL (U.S. Patent No. 8,969,302) formulation by Yeda Research & Development Co., Ltd.

Netherlands-based international pharmaceutical company Synthon, best known for developing complex generic therapeutics, has officially entered into an agreement with pharmaceutical giant Pfizer, Inc., effectively transferring the exclusive rights in the US to glatiramer acetate to Pfizer. Glatiramer acetate is an experimental generic formulation of Copaxone, which is indicated as a…

Reality TV star Jack Osbourne has partnered with Teva Pharmaceutical Industries Ltd. to launch a new website as part of a three-year campaign called You Don’t Know Jack About MS. The site can be viewed here: www.youdontknowjackaboutms.com. The campaign is meant to raise awareness about…

Teva Pharmaceutical Industries Ltd. recently made a major announcement on the U.S. Supreme Court‘s ruling on the matter of “Teva Pharmaceuticals USA, Inc. et al. Petitioners v. Sandoz Inc. et al. that reversed the Federal Circuit Court’s judgment of invalidity…

Israel-based biopharmaceutical company Teva Pharmaceutical Industries Ltd. announced last week that its thrice-weekly COPAXONE® (glatiramer acetate) 40mg/ml treatment for relapsing-remitting multiple sclerosis (RRMS) has received positive results in a decentralized procedure. The favorable outcome proceeds a Positive Assessment Report from the United Kingdom, the Reference Member…

Teva Pharmaceutical Industries Ltd., the company behind multiple sclerosis drug COPAXONE® (glatiramer acetate injection), has been pursuing the US Food and Drug Administration‘s decision against approving a generic version of the drug, by Mylan, Inc. Teva’s petition has been turned down several times,…

Teva Pharmaceutical Industries Ltd., the company that developed the injectable multiple sclerosis treatment Copaxone (Glatiramer acetate),  has announced their pursuit of regulatory approval in Japan. This development comes a year after signing an agreement with Takeda Pharmaceutical Co. Ltd. According to a…

One of the country’s leading non-profit multiple sclerosis organizations, the Multiple Sclerosis Association of America (MSAA), has just launched a new patient support website called, My MS Journey. It is a comprehensive online resource designed to answer the specific and varied needs of MS patients, whether they have…

Drug manufacturers Teva Pharmaceutical Industries Ltd. and Active Biotech announced that they expanding the ongoing clinical research program for the study of laquinimod, a potential treatment for primary progressive multiple sclerosis (PPMS), as the companies are now initiating the ARPEGGIO trial. In addition, Teva has also announced…

The U.S. Supreme Court deliberated on a request from Teva Pharmaceutical Industries Ltd. to preserve the patent of its multiple sclerosis drug Copaxone from generic competitors until September 2015. Recent reports indicate that the court gave the company a mixed opinion. The hearing occurred this…

The U.S. Food and Drug Administration (FDA) accepted the abbreviated new drug application (ANDA) for filing of a Glatiramer Acetate Injection for the treatment of patients with relapsing forms of multiple sclerosis (MS).

Two pharmaceutical companies, Teva Pharmaceutical Industries Ltd. (TEVA) and Active Biotech, have just confirmed reports that the Committee for Medicinal Products for Human Use (CHMP) is not recommending NERVENTRA (laquinimod) for use in treating relapsing-remitting multiple sclerosis (RRMS) within the European Union (EU), according to a recent press release. Despite CHMP’s disapproval of TEVA…

Petah Tikvah Israel-based Teva Pharmaceutical Industries Ltd. has suffered a setback in its fight to forestall release of generic competitors for its proprietary Copaxone Multiple Sclerosis drug. However, the company is expressing optimism that potential for recovery of Patent Infringement Damages may dissuade aspirant generic competitors from proceeding until a…