Teva Pharmaceuticals

EC slaps Teva with ā‚¬463M fine over misuse of Copaxone patents

The European Commission (EC) fined Teva Pharmaceuticals ā‚¬462.6 million ā€” more that $502 million ā€” 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…

Higher, Fewer Copaxone Doses Lowered Relapse Rates Over 7 YearsĀ 

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

Trial to Examine if Ocrevus Eases Cognitive Fatigue in RRMS

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

Ocrevus Top Choice of US Neurologists for Active SPMS, But Mayzent and Mavenclad Gaining Interest, Report Says

Genentech‘sĀ OcrevusĀ (ocrelizumab) continues to be the most prescribed medication to reduce inflammatory disease in people with active secondary progressive multiple sclerosisĀ (SPMS) amongĀ U.S. neurologists, even though Novartis’Ā MayzentĀ (siponimod) and EMD Serono’sĀ MavencladĀ (cladribine) were approved in March to treat this same MS…

Tecfidera May Work to Lower Relapses by Inducing Epigenetic Changes in T-cells, Study Suggests

TreatingĀ 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 ā€” 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 ofĀ Tecfidera (by Biogen) for people with relapsing-remitting forms of the disease.Ā However, their complete mechanism of action remains unclear. Aiming to address this gap, scientists at theĀ Advanced Science Research Center (ASRC) at The Graduate Center of The City University of New YorkĀ and theĀ 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) ā€” marketed asĀ CopaxoneĀ byĀ Teva Pharmaceuticals, with generic forms byĀ SandozĀ (asĀ Glatopa) and byĀ Mylan. All patients had stable disease for at least three months, but disease duration was shortest in untreated patients ā€” 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 typicallyĀ have an activated formĀ 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,Ā treatmentĀ 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 ā€” the addition of methyl groups ā€” in T-cells containing CD4, compared to glatiramer acetate. Specifically, this overmethylation was observed in a micro-RNA ā€” tiny RNA molecules than control gene expression ā€” 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 beenĀ implicatedĀ in MS. The epigenetic effects of FAEs were subsequently validated by comparing pre- to post-treatment with Tecfidera in seven patients. In turn, in vitroĀ (lab dish) experiments showed that FAEs act specifically on the activation of naĆÆve T-cells ā€” those able to respond to new pathogens to the immune system ā€” 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 studyā€™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 studyā€™s senior author, concluded:Ā "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."

Early Use of High-efficacy DMTs of Long-term Benefit to MS Patients, Real-world Study Reports

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, ā€œClinical Outcomes of Escalation vs Early Intensive Disease-Modifying Therapy in Patients With Multiple Sclerosis,ā€ was published in the journalĀ …

Teva Pharmaceuticals to Present New Data on Multiple Sclerosis Drugs Copaxone and Laquinimod at ECTRIMS 2015

The world’sĀ largest generic medicines manufacturer,Ā Teva Pharmaceutical, is at theĀ 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 COPAXONEĀ®Ā (glatiramer acetate injection), and product candidate for…

Pfizer Acquires Exclusive Commercialization Rights to Generic Copaxone for Relapsing Remitting Multiple Sclerosis

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…

3 Times a Week Dose Copaxone for Relapsing MS Receives Positive Outcome in Europe

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

Teva and Active Biotech Expand Investigational MS Treatment Program

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

Multiple Sclerosis Drug NerventraĀ® (Laquinimod) Disapproved in EU; Drug Developers Will Continue Research

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

Supreme Court Denies Injunction Request To Block Release Of Generic MS Drug, But Patent Fight Not Over Yet

Petah Tikvah Israel-basedĀ Teva Pharmaceutical Industries Ltd.Ā 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…