Copaxone 3TW (glatiramer acetate three times a week) / Teva - LARVOL DELTA

Effects of HLA-DRA, HLA-DQA1 and IL-6 Gene Variations to Glatiramer Acetate Resistance in Multiple Sclerosis Patients. (PubMed, Biochem Genet) - "In conclusion, by increasing the number of patients, more meaningful results can be achieved in future studies. Elucidating the pharmacogenetic characteristics (the drug-gene relationship) of MS patients using GA could lead to the development of personalized treatment strategies."

Journal • CNS Disorders • Immunology • Inflammation • Multiple Sclerosis • HLA-DQA1 • HLA-DRA • IL6

Teva Delivers Second Consecutive Year of Growth; Announces Strong Financial Results in Fourth Quarter and Full Year 2024, Led by Generics Performance and Innovative Portfolio Growth (GlobeNewswire) - "Duvakitug (Anti-TL1A) positive Phase 2B results announced and initiation of Phase 3 program is expected in 2025...AJOVY revenues in our United States segment in the fourth quarter of 2024 were $63 million, an increase of 11% compared to the fourth quarter of 2023...AUSTEDO revenues in our United States segment in the fourth quarter of 2024 increased by 27%, to $518 million, compared to $408 million in the fourth quarter of 2023...UZEDY (risperidone) extended-release injectable suspension revenues in our United States segment in the fourth quarter of 2024 were $43 million...COPAXONE revenues in our United States segment in the fourth quarter of 2024 were $63 million, a decrease of 13% compared to the fourth quarter of 2023, mainly due to market share erosion and competition, partially offset by a reduction in sales allowance."

Commercial • New P3 trial • CNS Disorders • Crohn's disease • Huntington's Disease • Migraine • Multiple Sclerosis • Schizophrenia

Slow Subcutaneous Release of Glatiramer Acetate or CD40-Targeting Peptide KGYY6 Is More Advantageous in Treating Ongoing Experimental Autoimmune Encephalomyelitis. (PubMed, Neurol Int) - "Slow-release formulations of both GA and KGYY6 vastly improve the efficacy of both, and KGYY6 is more consistent in efficacy across different lots."

Journal • CNS Disorders • Immunology • Multiple Sclerosis • CD40

Tolerability and Acceptance of Switching from Brand to Generic Glatiramer Acetate in Multiple Sclerosis. (PubMed, J Clin Med) - "Seventy-one percent of participants rated their acceptance of generic GA as 7/10 or higher. The results suggest that switching from brand to generic GA 40 mg/mL is safe, well-tolerated, and accepted by patients with MS."

Journal • CNS Disorders • Multiple Sclerosis

Adverse effects of immunotherapies for multiple sclerosis: a network meta-analysis. (PubMed, Cochrane Database Syst Rev) - "We found mostly low and very low-certainty evidence that drugs used to treat MS may not increase SAEs, but may increase withdrawals compared with placebo. The results suggest that there is no important difference in the occurrence of SAEs between first- and second-line drugs and between oral, injectable, or infused drugs, compared with placebo. Our review, along with other work in the literature, confirms poor-quality reporting of adverse events from RCTs of interventions. At the least, future studies should follow the CONSORT recommendations about reporting harm-related issues. To address adverse effects, future systematic reviews should also include non-randomized studies."

Adverse events • Journal • Retrospective data • Review • CNS Disorders • Multiple Sclerosis

Cost-Effectiveness of Ofatumumab Compared with Other Disease-Modifying Therapies for the Treatment of Relapsing Multiple Sclerosis in Greece (ISPOR-EU 2022) - "The purpose of this study was to evaluate the cost-effectiveness of ofatumumab vs currently available DMTs (interferon b-1a and -1b, dimethyl fumarate, teriflunomide, glatiramer acetate, ocrelizumab, natalizumab, and fingolimod) for RMS patients from the Greek payer perspective... From a Greek payer perspective, ofatumumab was estimated to be cost-effective compared to the other DMTs for the treatment of RMS patients."

HEOR • CNS Disorders • Multiple Sclerosis

Oral N-acetylglucosamine in Multiple Sclerosis Patients Raises N-glycan branching and Modifies Serum Cytokine Levels (ECTRIMS 2022) - " Forty-seven Multiple Sclerosis (MS) patients stable on glatiramer acetate therapy were sequentially recruited from UC Irvine MS program for a dose-escalation study. GlcNAc was well-tolerated and was biologically active in MS patients. Mild but tolerable gastrointestinal side effects were observed in the 12-gram dose. Randomized double blind studies are warranted to further explore the potential of oral GlcNAc on myelin repair and neurodegeneration in MS."

Clinical • CNS Disorders • Gastrointestinal Disorder • Immunology • Multiple Sclerosis • CD4 • IFNG • IL6

Long-term efficacy and safety of three times weekly dosing regimen of glatiramer acetate in relapsing multiple sclerosis patients: Seven-year results of the Glatiramer Acetate Low-frequency Administration (GALA) open-label extension study. (PubMed, Mult Scler J Exp Transl Clin) - "Adverse events were consistent with the well-established GA safety profile. GA40 treatment conferred clinical benefit up to seven years, resulting in sustained efficacy and was generally well tolerated in RMS patients."

Clinical • Journal • CNS Disorders • Multiple Sclerosis

[VIRTUAL] Adherence and Persistence to Injectable Disease-Modifying Therapies Among Patients with Multiple Sclerosis Enrolled in US Commercial Plans (CMSC 2021) - "Objectives: Compare adherence and persistence levels with peginterferon beta-1a (PEG) and other injectable DMTs in MS patients...Data from patients treated with subcutaneous (SC) PEG once every 2 weeks (n=275), intramuscular interferon (IFN) beta-1a once per week (QW; n=314), SC IFN beta-1a 3 times per week (TIW; n=463), SC IFN beta-1b every other day (QAD; n=236), SC glatiramer acetate (GA) once daily (QD; n=361), and SC GA TIW (n=2198) were included... Persistence and adherence were higher for PEG than for GA QD but not for GA TIW. This finding cannot be explained solely by the dosing schedule and may relate to the higher incidence of flu-like symptoms with IFNs than with GA. These results highlight an increase in PEG adherence that may reflect the increase in education and training on setting expectations for potential AEs."

Clinical • CNS Disorders • Multiple Sclerosis

[VIRTUAL] Phase 1 open label dose-escalation trial of oral N-acetylglucosamine in multiple sclerosis patients (ECTRIMS 2021) - " Forty-seven MS patients stable on glatiramer acetate therapy were sequentially recruited from UC Irvine MS program for a dose-escalation study. GlcNAc was well-tolerated and was biologically active in MS patients. Mild but tolerable gastrointestinal side effects were observed in the 12-gram dose. Randomized double blind studies are warranted to further explore the potential of oral GlcNAc on myelin repair and neurodegeneration in MS."

Clinical • Late-breaking abstract • P1 data • CNS Disorders • Gastrointestinal Disorder • Multiple Sclerosis • CD4

[VIRTUAL] Phase 1 open label dose-escalation trial of oral N-acetylglucosamine in multiple sclerosis patients (ECTRIMS 2021) - " Forty-seven MS patients stable on glatiramer acetate therapy were sequentially recruited from UC Irvine MS program for a dose-escalation study. GlcNAc was well-tolerated and was biologically active in MS patients. Mild but tolerable gastrointestinal side effects were observed in the 12-gram dose. Randomized double blind studies are warranted to further explore the potential of oral GlcNAc on myelin repair and neurodegeneration in MS."

Clinical • Late-breaking abstract • P1 data • CNS Disorders • Gastrointestinal Disorder • Multiple Sclerosis • CD4

[VIRTUAL] Low dose cannabidiol (CBD) treatment provided successful control of intractable seizures in secondary progressive multiple sclerosis patient: a case report (ECTRIMS 2021) - "Her overall treatment regimen included levetiracetam 3000 mg/day, valproic acid 1000 mg/day, lacosamide 200 mg/day, and glatiramer acetate 40-mg/mL. Although there is little evidence of using artisanal products in drug resistant focal seizures, in selected patients, CBD rich extracts or synthetic CBD products can be effective to control the seizures. In this patient CBD oil is also promising because of its anti-inflammatory and anxiolytic effects in MS."

Clinical • Ataxia • CNS Disorders • Epilepsy • Movement Disorders • Multiple Sclerosis • MRI

[VIRTUAL] Low dose cannabidiol (CBD) treatment provided successful control of intractable seizures in secondary progressive multiple sclerosis patient: a case report (ECTRIMS 2021) - "Her overall treatment regimen included levetiracetam 3000 mg/day, valproic acid 1000 mg/day, lacosamide 200 mg/day, and glatiramer acetate 40-mg/mL. Although there is little evidence of using artisanal products in drug resistant focal seizures, in selected patients, CBD rich extracts or synthetic CBD products can be effective to control the seizures. In this patient CBD oil is also promising because of its anti-inflammatory and anxiolytic effects in MS."

Clinical • Ataxia • CNS Disorders • Epilepsy • Movement Disorders • Multiple Sclerosis • MRI

Treatment of multiple sclerosis with glatiramer acetate: a new look (PubMed, Zh Nevrol Psikhiatr Im S S Korsakova) - "The final efficacy analysis included 150 patients treated for 12 months. The convenience of using a double dose of GA in 40 mg, which is registered on the territory of the Russian Federation by two manufacturing companies: CJSC BIOCAD and Teva Pharmaceutical Enterprises Ltd., has been proven."

Journal • CNS Disorders • Multiple Sclerosis

Effect of switching glatiramer acetate formulation from 20 mg daily to 40 mg three times weekly on immune function in multiple sclerosis. (PubMed, Mult Scler J Exp Transl Clin) - "Development of Th1, Th17, M1-like macrophages, M2-like macrophages, and Foxp3 Tregs was also comparable between the two groups. The immunological parameters measured in RRMS patients treated with GA40 three times weekly are largely comparable to those given daily GA20 treatment."

Journal • CNS Disorders • Immunology • Multiple Sclerosis • CSF2 • FOXP3 • IFNG • IL10 • IL12A • IL13 • IL17A • IL18 • IL1B • IL6 • MRI • TNFA

[VIRTUAL] Effect of switching glatiramer acetate formulation from 20 mg daily to 40 mg three times weekly on immune functions in RRMS (ACTRIMS Forum 2021) - "This study indicates that the immune parameters measured after one year of treatment in patients with GA40 are largely comparable to continuous GA20 treatment."

CNS Disorders • Multiple Sclerosis • CSF2 • FOXP3 • IFNG • IL10 • IL12A • IL13 • IL17A • IL18 • IL1B • IL6 • TNFA

Teva Pharmaceutical Industries: European Commission Opens Antitrust Investigation Against Teva Over Multiple-Sclerosis Drug (Market Screener) - "The European Commission said Thursday that it has opened a formal antitrust investigation into Israel-based pharmaceutical company Teva Pharmaceutical Industries Ltd. to assess whether it behaved in an anti-competitive manner with regards to its multiple-sclerosis drug Copaxone....Aims to determine whether Teva illegally delayed the market entry and uptake of medicines that compete with its own, the Commission said....Teva's alleged behavior may amount to an abuse of dominant position if proven, the Commission said."

Corporate lawsuit • CNS Disorders • Multiple Sclerosis

Copaxone 3TW: Protection of Copaxone 40mg/ml patent in EU until 2030 (Teva) - Annual Report 2020

Patent • Multiple Sclerosis

Teva Pharm sees growth in two main branded drugs in otherwise flat 2021 (Yahoo Finance) - “Sales growth this year is expected to come from branded drugs Huntington's disease treatment Austedo and migraine product Ajovy, which together are expected to reach about $1.2 billion, up from $821 million in 2020. But sales of multiple sclerosis drug Copaxone are expectedto drop by $300 million this year to $1.05 billion due to continued competition...Austedo sales rose 36% to $185 million in the fourthquarter, while sales of Ajovy gained 42% to $36 million."

Sales • Sales projection • CNS Disorders • Huntington's Disease • Migraine • Multiple Sclerosis

Teva Reports Fourth Quarter and Full Year 2020 Financial Results (Businesswire) - "Revenues in 2020 were $16,659 million, a decrease of 1% in both U.S. dollar and local currency terms, compared to 2019, mainly due to a decline in revenues from...COPAXONE...Revenues in the fourth quarter of 2020 were $4,454 million, flat compared to the fourth quarter of 2019. In local currency terms, revenues decreased by 1%, mainly due to lower revenues from Anda, our distribution business in the United States, COPAXONE...COPAXONE revenues in our International Markets segment in the fourth quarter of 2020 decreased by 10% to $15 million..."

Sales • CNS Disorders • Multiple Sclerosis

Matching comparisons of therapeutic efficacy suggest better clinical outcomes for patients treated with peginterferon beta-1a than with glatiramer acetate. (PubMed, Ther Adv Neurol Disord) - "Matching-adjusted peginterferon beta-1a patients (effective n = 276) demonstrated a similar ARR at 1 year (0.278 versus 0.318; p = 0.375) and significantly lower ARR at 2 years (0.0901 versus 0.203; p = 0.032) and 3 years (0.109 versus 0.209; p = 0.047) compared with GA 40 mg/ml TIW patients (n = 834). Results from separate matching comparisons of phase III clinical trials and extension studies suggest that peginterferon beta-1a 125 mcg Q2W may provide better clinical outcomes than GA (20 mg/ml QD or 40 mg/ml TIW)."

Clinical • Clinical data • Journal • CNS Disorders • Multiple Sclerosis

MS therapy for children is getting better [Google translation] (Pharm Ztg) - "As a standard, the affected children and adolescents with mild to moderate illness initially receive recombinant interferon-β or glatiramer acetate (Copaxone®)...In exceptional cases, dimethyl fumarate (Tecfidera®) can also be prescribed for mild and moderate forms. If the disease is progressing or is already highly active at diagnosis, fingolimod (Gilenya®) or natalizumab (Tysabri®) are preferred...Overall, however, it is foreseeable that an optimization of the therapy could achieve a further improvement in the situation for pediatric MS patients. The guideline, for which Huppke is one of two lead authors and which was last updated in January 2016, is to be reviewed from January."

Clinical guideline • CNS Disorders • Multiple Sclerosis

Federal Court decision regarding glatiramer acetate finds one patent obvious and another valid and infringed (JD Supra) - "...the Federal Court issued its decision in two patent infringement actions pursuant to subsection 6(1) of the Patented Medicines (Notice of Compliance) Regulations involving Teva’s patents pertaining to the drug glatiramer acetate (Teva’s COPAXONE and Pharmascience’s GLATECT): Teva v Pharmascience, 2020 FC 1158. Justice Kane found Canadian Patent No. 2,702,437 (437 patent) invalid for obviousness while Canadian Patent No. 2,760,802 (802 patent) was found valid and infringed by Pharmascience if it proceeds to market its product."

Patent • CNS Disorders • Multiple Sclerosis

Humana Sues Teva Over Alleged Copay Fraud Scheme (Law360) - Subscription needed.

Corporate lawsuit • CNS Disorders • Multiple Sclerosis

Teva can't protect blockbuster Copaxone by reclassifying as biologic (Reuters) - "Teva Pharmaceutical Industries Ltd has lost a bid to force the U.S. Food and Drug Administration to regulate its blockbuster multiple sclerosis drug Copaxone as a biologic drug, which would have expanded its ability to sue would-be generic rivals....Federal court on Thursday granted summary judgment to the FDA and to Sandoz Inc and Mylan Pharmaceuticals Inc, which intervened in the case, calling Teva’s lawsuit 'yet another effort to stifle Copaxone competitors.'"

Corporate lawsuit • CNS Disorders • Multiple Sclerosis