Copaxone

Pendopharm’s Glatect (glatiramer acetate injection), a lower cost alternative to Teva’s Copaxone, has been added to the public health plans of five Canadian provinces for patients with…

After an agreement to lower their prices, four treatments for relapsing multiple sclerosis — Biogen’s Avonex and Merck KGaA‘s Rebif (both interferon beta-1a), Novartis’ Extavia (interferon beta 1b), and Teva’s Copaxone (glatiramer acetate) — were recommended as cost-effective and long-term therapy options within the National Health Service…

Mylan and Mapi Pharma will jointly develop and commercialize Glatiramer Acetate (GA) Depot, an investigative, long-lasting formulation of the commonly used multiple sclerosis (MS) therapy Copaxone (marketed by Teva Phatmaceutical). Under the terms of the partnership, Mylan will acquire global marketing rights for the therapy. The companies are in…

Brabio (glatiramer acetate injection), the first generic alternative to Copaxone for relapsing multiple sclerosis (MS) patients, was recently launched in the U.K. at an equivalent higher dose, its maker, Mylan, announced. Similar to Copaxone  — developed by Teva — Brabio is now available at a 40 mg/ml dose. Both medications are…

Synthon’s prefilled syringe with 40 mg/ml of glatiramer acetate — the generic version of Teva Pharmaceutical’s Copaxone 40 mg — has received regulatory clearance in all 28 member states of the European Union (EU) plus Iceland, Liechtenstein and Norway to treat relapsing-remitting multiple sclerosis (RRMS). The low-dose…

The U.S. Food and Drug Administration has approved both lower and higher doses of Mylan’s generic versions of Copaxone (glatiramer acetate) for relapsing multiple sclerosis. It is the first time the agency has authorized a higher-dose generic. Generic versions of the lower dose of 20 mg/mL — intended for…

A European Patent Office decision has opened the door to Synthon providing cheaper generic versions of Teva Pharmaceutical’s Copaxone to people with relapsing multiple sclerosis. What looks like the final hurdle to the generics was cleared when the patent office’s Technical Board of Appeal revoked the last of the patents that Teva…

Ocvevus (ocrelizumab) is off to a running start, Tecfidera (dimethyl fumarate) leads the pills and the four injectable multiple sclerosis drugs are being used by fewer MS patients. But Copaxone (glatiramer acetate injection) remains the leader of the pack of the disease-modifying therapies. Those are…

First-line treatment with Copaxone (glatiramer acetate) benefits relapsing-remitting multiple sclerosis (RRMS) patients by boosting the number of anti-inflammatory immune cells and restoring the balance of regulatory immune cells, an Italian study shows. The study, “Biological activity of glatiramer acetate on Treg and anti-inflammatory monocytes persists for more than 10…

Two studies that recently appeared in the Multiple Sclerosis Journal shed light on how contraceptive use may affect women with MS, as well as how the disease might affect the safety and effectiveness of birth-control medications. Relapsing MS patients treated with older drugs such as interferons and Copaxone (glatiramer acetate) have a…

Babies of women with relapsing multiple sclerosis (RMS) who receive daily injections of Copaxone (glatiramer acetate) while pregnant carry the same risk of developing birth defects as babies as a whole, according to a study by the therapy’s developer, Teva Pharmaceutical Industries. The findings can help doctors counsel and treat…

(Editor’s note: Tamara Sellman continues her occasional series on the MS alphabet with this second of three parts on terms starting with the letter “C.”) When it comes to multiple sclerosis, mastering an understanding of the disease means you need to mind your Ps and Qs, dot your Is, cross your Ts,…

An extension trial assessing generic glatiramer acetate (GTR) treatment in multiple sclerosis (MS) patients found that the formulation is as safe and effective as Copaxone (branded glatiramer acetate), and that switching to GTR is well-tolerated. The findings were in the study, “Switching from branded to generic glatiramer acetate:…

Here’s my Pick of the Week’s News, as published by Multiple Sclerosis News Today. Imbalances in Brain Microbiota May Be Behind Demyelination in MS, Study Says Good to see that new research involving humans (NOT mice this time) may lead to better understanding of MS. Alterations…

European users of Copaxone (glatiramer acetate injection, Teva Pharmaceutical) to treat relapsing forms of multiple sclerosis (RMS) will no longer see a warning that the drug should not be used during pregnancy. A report assessing this change in the drug’s marketing authorization within the European Union — a process known as…

Alvogen recently announced the launch of Remurel (glatiramer acetate) in Central and Eastern Europe, making it the first generic equivalent of Copaxone  to be clinically validated for the treatment of relapsing forms of multiple sclerosis (RRMS) in Europe. European health authorities determined that Remurel 20 mg was the therapeutic equivalent…

Health Canada has approved Teva Canada Innovation‘s three-time weekly 40 mg/mL injection of Copaxone (glatiramer acetate) that allows less frequent dosing for patients with relapsing-remitting multiple sclerosis (RRMS). The approval was grounded primarily on data resulting from the Phase 3 Glatiramer Acetate Low-Frequency Administration (GALA) study, the largest Copaxone clinical…

The Russian Ministry of Health recently granted Marketing Authorization (ЛП-003567) to R-Pharm JSC for the development of  “Glatirat” (Glatiramer acetate), a drug intended for the treatment of patients with relapsing-remitting multiple sclerosis (RRMS) and clinically isolated syndrome. According to a press release, the registration of “Glatirat” was based…

Takeda Pharmaceutical, a pharmaceutical company based in Osaka, Japan, recently announced that a widely approved drug treatment for the prevention of relapses in multiple sclerosis (MS) is now available in Japan as well. Copaxone, (glatiramer acetate; 20 mg daily subcutaneous injection), developed by Teva Pharmaceuticals, is an immunomodulatory drug designed to act as…

In a recent study entitled “Equivalent Gene Expression Profiles between Glatopa™ and Copaxone®,” authors determined potential differences in treatment responses by investigating the gene expression profile of two approved treatments for relapsing forms of multiple sclerosis – Copaxone and Glatopa. Both of these MS therapies are glatiramer…

Teva Pharmaceutical Industries Ltd., a leading global pharmaceutical company that delivers high-quality, patient-centric healthcare solutions to millions of patients every day, recently announced the approval of a Marketing Authorization license (MA) by the Russian Ministry of Health for three-times-per-week COPAXONE®(glatiramer acetate injection) 40 mg/mL, a new dose of COPAXONE®,…

The Glatiramer Acetate Clinical Trial to Assess Equivalence With Copaxone  (GATE) seems to be the first phase 3 clinical trial to test a generic disease-modifying medication for multiple sclerosis (MS) treatment. The data showed that glatiramer acetate, the generic drug, was equivalent to the trademark drug Copaxone for the…

A Satellite Symposia entitled “Discovering a new world in MS” presented by Teva Neuroscience was held yesterday, October 8 at the 31st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) currently taking place in Barcelona, Spain, October 7 – 10, 2015. Dr. Omar Khan from the…

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…

Teva Pharmaceutical Industries Ltd., a leading global pharmaceutical company that delivers high-quality, patient-centric healthcare solutions, recently announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) approved the once per day 20 mg injection of COPAXONE® as prophylaxis for relapses in multiple sclerosis (MS). Glatiramer acetate, the active…

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…

The U.S. Food and Drug Administration (FDA) has announced the approval of the first generic version of Copaxone (glatiramer acetate injection) for the treatment of relapsing forms of multiple sclerosis (MS). The administration has granted Sandoz marketing authorization for glatiramer acetate in 20 mg/1 ml…

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…

Takeda Pharmaceutical Company Limited (Takeda) announced late last month its New Drug Application (NDA) to Japan’s Ministry of Health, Labour and Welfare for the multiple sclerosis relapse prevention drug glatiramer acetate (active ingredient) — which is sold in some markets under the trade name Copaxone. Developed by Israel’s Teva Pharmaceutical Industries…