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Copaxone, Glatopa and glatiramer acetate

 

Copaxone patent invalidated again(19/06/15)

A U.S. appeals court has again invalidated a patent held by Teva Pharmaceutical Industries on its top-selling multiple sclerosis drug Copaxone, clearing the way for the launch of a cheaper, generic version.

The 2-1 decision by the U.S. Court of Appeals for the Federal Circuit, the nation's top patent tribunal, was a blow to Teva in its seven-year fight against two generic drugmakers over the patent protections for Copaxone.

It is the second time the appeals court has reviewed Teva's patent. In January, the U.S. Supreme Court said the appeals court took the wrong approach in its original decision to cancel the patent.

The extended litigation has benefited Teva, which has been able to continue to sell Copaxone without competition from other manufacturers that would offer steep discounts for their generic versions.

A Teva spokesman said the company is "committed to pursuing all legal pathways, including seeking further appellate review."

Two teams have been developing generic forms of Copaxone: one involving Novartis AG's Sandoz unit and Momenta Pharmaceuticals Inc and another involving Mylan Inc and Natco Pharma Ltd.

Momenta president and CEO Craig Wheeler said in a statement the company was pleased with the decision.

"We look forward to providing patients with a more affordable generic alternative for the treatment of multiple sclerosis," he said.

Teva's patent covered a method of manufacturing the drug. The Federal Circuit said that under the high court's latest standards for determining when a patent is too vague to deserve legal protection, the Teva patent is indefinite.

Teva "has failed to inform with reasonable certainty those skilled in the art about the scope of the invention," the court said.

Teva had sued Sandoz and Mylan in 2008 and 2009 in federal court in New York for patent infringement over their Copaxone copycat versions.

Central to the case was how the district judge interpreted a specific term in a key patent for the drug. The appeals court did not accept that interpretation and invalidated the patent.

The Supreme Court said the Federal Circuit should have deferred to the district judge unless there is evidence of "clear error," sending the case back down.

Source: Reuters © Thomson Reuters 2015 (19/06/15)

Early treatment with Copaxone ‘benefits patients’(24/04/15)

Teva has announced new data on the safety and efficacy of Copaxone (glatiramer acetate injection) 40mg/mL in patients with relapsing forms of multiple sclerosis (MS).

In the 36-month placebo-controlled and open-label extension phases of the Glatiramer Acetate Low-frequency Administration (GALA) study, outcomes of early start (ES) patients who received three-times-a-week Copaxone 40mg/mL for 36 months were compared to delayed start (DS) patients who initiated Copaxone after the 12-month placebo-controlled phase of the trial. The adjusted mean annualized relapse rate was significantly lower for the ES patients over 36 months and early treatment was associated with a sustained reduction in lesion activity and the evolution of active lesions to chronic black holes.

Copaxone is indicated to reduce the frequency of relapses in patients with relapsing-remitting MS, including those who have experienced a first clinical episode and have MRI features consistent with MS.

Source: MPR Copyright © 2015 Haymarket Media, Inc (24/04/15)

Generic version of MS drug gets FDA approval(17/04/15)

The Food and Drug Administration has approved the first-ever generic version of the multiple sclerosis drug, Copaxone, which was developed by Momenta Pharmaceuticals. However, it’s still unclear when the drug might become available to patients.

Momenta developed the drug, to be marketed under the name Glatopa, in partnership with New Jersey-based generics company, Sandoz.

The original drug of which Glatopa is a generic version, called Copaxone, is marketed by Israeli drug firm Teva Pharmaceuticals and generated more than $4bn in revenue last year.

Momenta’s attempts to get approval of Glatopa have been tied up in patent battles with Teva. A statement from Momanta says only that Sandoz “is currently evaluating launch timing.”

Source: Boston Business Journal © 2015 American City Business Journals. (17/04/15)

US Supreme Court sides with Teva in patent dispute over multiple sclerosis drug(20/01/15)

The Supreme Court has sided with Teva Pharmaceutical Industries Ltd. in the company's high-profile patent dispute with rival firms over the top-selling multiple sclerosis drug.

The justices ruled Tuesday that a federal appeals court wrongly overturned five of Teva's patents for the drug Copaxone. The decision allows the Israel-based company to keep its exclusive rights to the drug until September 2015.

Copaxone generates about $4 billion in annual sales for Teva.

Teva had argued that the U.S. Court of Appeals for the Federal Circuit should not have second-guessed factual findings made by a federal district court that had earlier ruled in Teva's favour.

The justices agreed that the Federal Circuit should have deferred to factual findings made by the lower court.

Source: Star Tribune National © 2015 StarTribune (20/01/15)

Thrice-weekly Copaxone dosing receives pelminary positive outcome in Europe(09/12/14)

Teva Pharmaceutical Industries Ltd. announced 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 favourable outcome proceeds a Positive Assessment Report from the United Kingdom, the Reference Member State’s Medicines and Healthcare Products Regulatory Agency (MHRA), and all Concerned Member States (CMS) in Europe that had participated in the procedure. The company is anticipating the granting of national marketing authorizations for Copaxone® very soon.

The Reference Member State’s Positive Assessment Report was based on the impressive findings from Teva’s Phase III Glatiramer Acetate Low-Frequency Administration (GALA) study, which involved over 1,400 patients. Results revealed patients dosed three times a week with Copaxone 40 mg/mL experienced significantly reduced relapse rates at 12 months, and a favorable safety and tolerability profile.

Dr. Rob Koremans, the President and CEO of Global Specialty Medicines at Teva Pharmaceutical, said the company is eager to bring this proven, improved formulation of Copaxone to patients living with RRMS to Europe. They are projecting the drug’s availability in Europe to begin as soon as Q1 2015 in Germany, the Netherlands, and Denmark, with other EU countries following suit as 2015 progresses.

Copaxone is Teva’s only FDA-approved drug for multiple sclerosis, with the once-a-day formulation receiving approval in Europe in 2000. The three times a week 40 mg/ml formulation gives patients a more convenient treatment option in that it bundles improved efficacy in a more spaced-apart, subcutaneous dosing. Clinical studies have shown three-times-a-week Copaxone can maintain the benefits of the once-a-day formulation, with up to 60 percent fewer injections. The drug has already been prescribed to over 40,000 RRMS patients since its approval in the United States earlier in January 2014.

The President of Global R&D and Chief Scientific Officer at Teva, Michael Hayden, M.D., Ph.D., said: “Teva has been committed to the pursuit of MS research, and the development of Copaxone®, for more than 20 years. We are proud to be able to bring to patients in Europe the option of this new, three-times-a-week-Copaxone® 40 mg/ml formulation which we believe will offer patients and their physicians flexibility in choosing a dosing regimen that works best for them.”

Source: Multiple Sclerosis News Today © Copyright 2014 BioNews Services, LLC (09/12/14)

Copaxone moves toward Japanese regulatory approval(13/11/14)

Teva Pharmaceutical Industries Ltd. multiple sclerosis treatment Copaxone is progressing toward regulatory approval in Japan. At the end of 2013, Teva reported a development and marketing agreement with Japan's Takeda Pharmaceutical Co. Ltd. for the Japanese market.

At the time, Teva said that regulatory approval was expected to be received in less than a year. However, nearly a year has passed and no approval has been received.

The annual market potential for Copaxone in Japan is estimated at $700-900 million. Sales of the rug in the first nine months of 2014 totaled $3.1 billion. But in North America and Europe, such high sales of the treatment (in its smaller dosage) are nearing the end of their cycle due to the expiration of patents, and the Japanese market is expected to provide a welcome boost for Copaxone.

Teva said, "Our agreement with Takeda to bring this important medicine to patients in Japan is progressing positively. Together with Takeda, we are working through the remaining aspects of the process in order to meet the requirements of the Japanese authorities. We are hopeful to be in a position to complete the filing in the near future."

Estimates are that Copaxone is responsible for more than half of Teva's profits.

Source: Globes © Globes 2014. (13/11/14)

Glatiramer acetate MS therapy remodels the composition of B-cells(30/09/14)

The Effect of Glatiramer Acetate Therapy on Functional Properties of B Cells From Patients With Relapsing-Remitting Multiple Sclerosis.

Sara J. Ireland, BA; Alyssa A. Guzman, BS; Dina E. O’Brien, BS; Samuel Hughes; Benjamin Greenberg, MD; Angela Flores, MD; Donna Graves, MD; Gina Remington, BSN, RN; Elliot M. Frohman, MD, PhD; Laurie S. Davis, PhD; Nancy L. Monson, PhD.

Abstract

Importance: This study describes what is, to our knowledge, the previously unknown effect of glatiramer acetate therapy on B cells in patients with relapsing-remitting multiple sclerosis (MS).

Objective: To determine whether glatiramer acetate therapy normalizes dysregulated B-cell proliferation and cytokine production in patients with MS.

Design, Setting, and Participants: Twenty-two patients with MS who were receiving glatiramer acetate therapy and 22 treatment-naive patients with MS were recruited at The University of Texas Southwestern Medical Center MS clinic. Cell samples from healthy donors were obtained from HemaCare (Van Nuys, California) or Carter Blood Bank (Dallas, Texas). Treatment-naive patients with MS had not received any disease-modifying therapies for at least 3 months before the study.

Exposures: Glatiramer acetate therapy for at least 3 months at the time of the study.

Main Outcomes and Measures: B-cell phenotype and proliferation and immunoglobulin and cytokine secretion.

Results: A restoration of interleukin 10 production by peripheral B cells was observed in patients undergoing glatiramer acetate therapy as well as a significant reduction of interleukin 6 production in a subset of patients who received therapy for less than 32 months. Furthermore, proliferation in response to high-dose CD40L was altered and immunoglobulin production was elevated in in vitro–activated B cells obtained from patients who received glatiramer acetate.

Conclusions and Relevance: Glatiramer acetate therapy remodels the composition of the B-cell compartment and influences cytokine secretion and immunoglobulin production. These data suggest that glatiramer acetate therapy affects several aspects of dysregulated B-cell function in MS that may contribute to the therapeutic mechanisms of glatiramer acetate.

Source: JAMA Neurology. Published online September 29, 2014. doi:10.1001/jamaneurol.2014.1472 © 2014 American Medical Association (30/09/14)

First generic medication for MS developed(11/09/14)

New study finds a generic version of Copaxone to be just as effective, safe

A new study on the first generic medication for Multiple Sclerosis is showing promising results when compared to the widely-used name brand medication, Copaxone.

"The study was positive. It showed that the generic version of glatiramer acetate, Copaxone, was equivalent," said Cleveland Clinic neurologist Dr. Jeff Cohen, a principal investigator in this study.

Cohen and his team of researchers tested the effects of generic glatiramer acetate on nearly 800 people. MRI was used to determine if the generic version was comparable at inhibiting brain-lesion activity. Researchers also checked the generic's effectiveness at controlling relapses and other disability changes.

Cohen says the generic is not only comparable but it is equally safe. He says the next step will be to complete the extended follow-up on the safety and efficacy of the drug, but added the initial results are encouraging.

"So, we think these are very interesting results and hopefully will lead to the availability of generic versions of some of the multiple sclerosis medications, which could lead to significant cost-savings," Cohen said.

After the next round of tests, Cohen says the medication would then be considered for approval from the Food and Drug Administration. He hopes the generic version will be available sometime next year.

Source: News4Jax Copyright 2014 by News4Jax.com (11/09/14)

Teva’s Copaxone patent problems continue(01/09/14)

Teva Pharmaceuticals Industries Ltd is in trouble again for its multiple sclerosis (MS) injectable drug - Copaxone, as other drug manufacturers seek to launch their own generic versions of the drug. Teva has been fighting patent battles to ward off other pharmaceutical companies from making generic copies of Copaxone.

Copaxone makes up one-fifth of the company’s sales, but it is expected to lose 50% of its revenues by 2016, after its generic copies are launched. To deal with this impending threat, Teva introduced an improved version of the drug, with a higher dosage. But despite the introduction of the new Copaxone 40mg, troubles continue to pile up for the company.

Yesterday, Mylan Inc (MYL) and the duo of Novartis AG (ADR) (NVS)’s Sandoz unit and Momenta Pharmaceuticals, Inc (MNTA) announced that they have filed an Abbreviated New Drug Application (ANAD) for the Copaxone 40mg/mL with the US Food and Drug Administration (FDA). The ANAD, if approved, will allow the duo to manufacture and market a generic version of the drug, possibly at a low cost, which is a huge threat to the Israel-based company.

Copaxone – Teva’s Hero

Copaxone, launched in the US in 1997, is a drug for the treatment of relapsing multiple sclerosis (MS). The drug turned out to be a huge success for the company and generated $4.3 billion in sales last year, making 21% of the company’s sales. It also constitutes 42% of the company’s earnings.

However, the drug’s patent expired on May 24 this year. In order to deter launches of generic versions of the drug and to sustain its sales from Copaxone, Teva rolled out a new version of Copaxone in January - the new Copaxone is a 40 mg compared to the earlier 20 mg dose. The increased dose reduced the frequency of the drug administration significantly, from a daily dose to only three-times a week. The move worked for Teva, as in its last earnings announcement, CEO Erez Vigodman said that 51% patients had already converted to the new drug, and that the company is targeting a 65% conversion rate. The new version of the drug has patent protection until 2030.

Earlier Patent Battles

Teva, itself manufactures generic versions of many drugs, but it filed a patent infringement case against Sandoz in 2013, claiming that it was developing drugs similar to Copaxone, and violating Teva’s rights. The case was ruled against Teva, following which, Teva filed an appeal against the ruling.

Few months before Copaxone’s patent expiration, it filed a case in the US Supreme Court, seeking to delay the release of generic versions of the drug, until a ruling for the infringement case was given. Once again, the Supreme Court gave a decision against Teva’s expectations stating that any damages caused to Teva, will be recovered once the infringement case is finalised.

Teva still didn’t give up and filed a citizen petition with the FDA, asking the authority to order Mylan and Sandoz to conduct full-fledged clinical trials, which the FDA declined. In retaliation, Teva sued the FDA in Washington federal Court on May 9, claiming that the regulatory authority had wrongly rejected Teva’s appeal. Once again, Teva lost the case.

New Problem

Teva’s efforts seem to have gone in vain, as yesterday Mylan and Sandoz both filed ANAD applications with the FDA for the development of generic versions of the new Copaxane 40mg, with a similar thrice a week regimen. Teva is expected to sue both companies for patent infringement, which will trigger a 30 month stay on the sale of any generic drug. But if Teva is unable to get a favorable decision before the end of the stay period, Mylan and Sandoz can launch their own biosimilar, as early as 2017.

This will be a big blow to the company, as Copaxone is a crucial part of its sales. The Copaxone 40mg has already earned $411.5 million in revenues since its launch, however cheaper versions of the drug will deeply reduce its sales. Copaxone 40mg is priced at $60,500 per year, only $1000 less than Copaxone 20mg. Any cheaper versions of the drug are expected to do well.

More importantly, Teva also faces competition from new MS oral drugs that have been launched recently. Biogen’s Tecfidera and Novartis’s Gilenya are both oral pills and can be administered more easily.

Going forward, it will be crucial for Teva to maintain sales from the MS segment, by developing new drugs for this disease. Currently, it has a MS drug called, Laquinimod, in its pipeline, which will be an oral treatment and is already in its phase 3 trials.

Teva’s stock has gained almost 30% year-to-date, as the company is trying hard to stop generic copies of its drugs from making it to the market.

Source: Bidness etc. © Bidness 2014 (01/09/14)