Copaxone and glatiramer acetate
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)
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)
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)
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.
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)
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.
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)
The risk of developing lipoatrophy for multiple sclerosis (MS) patients administrated with glatiramer acetate is greater than 60 percent, according to a study developed at the Riverside Medical Clinic that reviewed 73 MS patients. It was already known that the drug could cause the condition, however the rate is higher than what was originally thought, according to the study.
It is “substantially higher than previously reported and is often the sole factor prompting patients to switch to another MS disease-modifying therapy. Our data also suggest that a heightened risk of lipoatrophy is an inherent autoimmune problem and is not necessarily mitigated by vigilant injection-site rotation. The psychological consequences may be significant,” said investigator Dr. Ronald Bailey, director of the MS clinic at the Riverside Medical Clinic.
From the patients who received the glatiramer acetate (Copaxone) therapy, 63 percent, or 46 participants in the study, developed lipoatrophy. Most of the patients were women, and 55% of them were administrated the drug with an auto injector. Copaxone is a daily subcutaneous injection that works as a disease-modifying therapy, and is widely used n treatment of RRMS. Lipoatrophy is a condition characterised by the loss of subcutaneous fat, and may lead to disfiguration.
In the research, it was also noted that there was no improvement in the dents that appear on the surface of the skin associated with the condition during the 3-year observation period. Scientists also performed photographic documentation and instructive guides about the proper injection process. The reason for the correlation between Copaxone and lipoatrophy is still not fully understood, but Dr. Baily believes that perhaps ”an elevation in tumor necrosis factor–alpha causes a dedifferentiation of adipocytes in the subcutaneous tissue.”
The disease “appears to progress, even when you stop the injections. It’s a pretty impressive disfiguration. It’s important to emphasise that this isn’t necessarily going to be remedied with plastic surgery. However, if patients were stable, most of them thought that this was a small price to pay to be in remission,” Dr. Bailey said at a meeting of the Consortium of Multiple Sclerosis Centers and the Americas Committee for Treatment and Research in Multiple Sclerosis.
Some of the patients developed Lipoatrophy in the first three months of the treatment, which suggested an autoimmune reaction, according to the research. ”Upon GA treatment discontinuation, lipoatrophy remained permanent,” he noted. GA labeling alerts to a 2 percent risk with a 20-mg/mL daily dose and 0.5% with the 40-mg/mL three times weekly option. The former one is used for almost two decades, while the latter was approved this year by the Food and Drug Administration.
“Lipoatrophy is thought to be permanent. There is no known therapy. To assist in possibly minimizing these events, the patient should be advised to follow proper injection technique and to rotate injection sites with each injection,” according to the GA label. However, another study performed at the Riverside Clinic concluded that site rotation wouldn’t decrease the probabilities of developing the condition.
Source: Multiple Sclerosis News Today © Copyright BioNews Services, LLC 2014 (18/06/14)
Teva Pharmaceutical Industries Ltd. lost a bid to block approval of a generic form of Copaxone, a multiple sclerosis drug that may account for half the company’s profit, 10 days before the patent on the medication expires.
Teva’s lawsuit, accusing the Food and Drug Administration of improperly dismissing its calls for more testing of generic forms of Copaxone before they go on the U.S. market, was thrown out yesterday by a federal judge in Washington. Copaxone, the company’s bestselling drug, contributes more than 50 percent of earnings, according to analysts.
The May 10 suit was Teva’s latest move in a campaign to block rivals including Mylan Inc. and Novartis AG’s Sandoz unit from making a less-expensive generic drug. Last month, a U.S. Supreme Court justice rejected Teva’s bid for an injunction to prevent the sale of generic competitors’ products.
Teva is appealing a judge’s 2013 dismissal of Teva’s suits against Mylan and Sandoz for infringing patents covering Copaxone. That case is pending before the Supreme Court.
U.S. District Judge Ellen Huvelle said in her order yesterday that the lawsuit was brought prematurely and as a result she lacked authority to hear it. The complaint can be refiled later, she said.
Teva is evaluating what it can do next, Denise Bradley, a spokeswoman for for the Petach Tikva, Israel-based company, said in an e-mailed statement.
The suit was “the only option available to us” because of a lack of transparency in the drug review process and the agency’s failure to offer a “meaningful response” to Teva’s requests for more extensive scrutiny of the generics its competitors plan to sell, Bradley said.
The FDA characterized the suit in court papers as an effort by Teva to extend its “monopoly” for Copaxone.
In the past six years, Teva has filed six petitions at the FDA “with various legal and scientific assertions and requests, each time making the same demand: that FDA not approve any generic competitor’s product without requiring, among other things, a full set of clinical trials,” agency lawyers wrote, urging Huvelle to dismiss the case.
The FDA said Teva wanted the court to decide that applications for generic Copaxone couldn’t be approved “without first meeting Teva’s additional ‘conditions.’” The agency called the demand was “absolutely unprecedented, extra-statutory, and extra-judicial.”
A 20-milligram dosage of Copaxone is set to go off patent on May 24. A delay in approval of generic competition would give Teva more time to switch patients to a 40-milligram dose it says is covered by other patents until 2015.
The case is Teva Pharmaceutical Industries LTD v. Sebelius, 14-cv-00786, U.S. District Court, District of Columbia (Washington).
Source: Bloomberg ©2014 Bloomberg L.P.(15/05/14)
Teva Pharmaceutical Industries Ltd. sued U.S. regulators seeking to block approval of a generic version of its multiple-sclerosis drug Copaxone, a product that accounts for more than half the company’s revenue and is set to go off patent on May 24.
Teva, based in Petach Tikva, Israel, contends in the complaint that U.S. Food and Drug Administration officials improperly dismissed the drugmaker’s calls to subject competitors’ generic versions of Copaxone to extensive testing before they go on the U.S. market.
The suit, filed in federal court in Washington, is the company’s latest move in its campaign to block generic rivals such as Mylan Inc. and Novartis AG’s Sandoz unit from putting out a less-expensive version of Copaxone. Last month, a U.S. Supreme Court justice rejected Teva’s bid for an injunction to prevent the sale of generic competitors’ products.
“Unless this court acts now, the FDA’s gamesmanship will preclude Teva from obtaining meaningful judicial review before the FDA allows these putative generic products to overwhelm the market,” the company said in the complaint.
Copaxone brings in $3.2 billion in annual U.S. sales and accounts for more than half of Teva’s profit. A delay would give Teva more time to switch patients from the 20-milligram dose that is slated to come off patent protection to a 40-milligram dose it says is covered by other patents until 2015.
Sandy Walsh, an FDA spokeswoman, didn’t immediately return a call for comment on Teva’s Copaxone suit.
Teva is appealing a judge’s 2013 dismissal of Teva’s suits against Mylan and Sandoz for infringing patents covering Copaxone. The case is pending before the U.S. Supreme Court.
Sandoz, based in Basel, Switzerland, and Canonsburg, Pennsylvania-based Mylan originally were sued by Teva after they asked the FDA for approval of generic drugs to compete with Copaxone, prescribed to reduce the frequency of relapses in MS patients.
In today’s suit, Teva officials said they filed a petition to require generic versions of Copaxone to undergo clinical-trial studies before being approved for sale. The FDA rejected that petition May 2 without addressing the merits of Teva’s request, according to the complaint.
“There is no question that the agency’s actions violate Teva’s statutory right to receive a decision on the merits of its petition within the law’s statutory” deadline, the company said in the complaint.
Teva faces “irreparable harm” if the court doesn’t block Copaxone’s generic competitors, according to the complaint. The drugmaker “stands to lose hundreds of millions of dollars within months of the FDA approving” the generic products, the company said.
The case is Teva Pharmaceutical Industries LTD v. Sebelius, 14-cv-00786, U.S. District Court for the District of Columbia (Washington).
Source: Bloomberg © 2014 BLOOMBERG L.P (12/05/14)
Supreme Court Chief Justice John Roberts on Friday declined to temporarily block a lower court ruling that opens the world's bestselling multiple sclerosis drug to competition from generic rivals next month.
The decision is a victory for rivals challenging the patents of Israel-based Teva Pharmaceutical Industries Ltd., maker of the drug Copaxone.
Teva claims the U.S. Court of Appeals for the Federal Circuit wrongly overturned five of its patents for the drug. That ruling allows rivals Mylan Inc., Momenta Pharmaceuticals Inc. and Sandoz, Inc., to start selling cheaper generic versions in May instead of September 2015.
The Supreme Court has agreed to consider the case, but arguments won't take place until its new term begins in October and it could be next year before a decision is reached. Teva said it would suffer irreparable harm if the appeals court decision was not postponed. Copaxone brought the company $3.2 billion in U.S. sales last year.
In a one-page ruling, Roberts said he was not convinced Teva would suffer such harm. If Teva ultimately prevails in the case, Roberts said, the company would be able to recover damages from the generic rivals for past patent infringement. He acknowledged that Teva has "a fair prospect" of ultimately winning the case at the high court.
Roberts oversees emergency appeals from the U.S. Court of Appeals for the Federal Circuit, which hears appeals in patent cases.
It is the second time Roberts has declined to put the appeals court ruling on hold. He rejected a similar request from Teva in November while the high court was deciding whether to take up the appeal.
The rival companies had argued that granting a stay would effectively extend Teva's monopoly for years to come. That's because Teva is trying to switch existing Copaxone patients to a new formulation of the drug that has patent protection until 2030.
Source: Global Post Copyright 2014 Canadian Press (21/04/14)
Teva Pharmaceutical Industries Ltd has asked the U.S. Supreme Court to stop a lower court ruling from going into effect while the justices consider an appeal in a patent fight over Teva's top-selling multiple sclerosis drug Copaxone.
On March 31, the high court agreed to hear Teva's appeal of a July 2013 ruling by the U.S. Court of Appeals for the Federal Circuit in favor of two teams developing cheaper generic forms of Copaxone: one involving Novartis AG's Sandoz Inc and Momenta Pharmaceuticals Inc, and the other involving Mylan Inc and Natco Pharma Ltd.
The appeals court had upheld some of the nine patents involved in the drug, or portions of them, but declared several invalid, meaning patent protections were set to expire in May 2014 instead of September 2015.
The company's lawyers said in the court filing that if the appeals court ruling was not stayed, "Teva's innovative and widely prescribed treatment for multiple sclerosis will lose protection."
The Supreme Court will not be hearing oral arguments in the Teva case until its 2014 term begins in October. A ruling could come as late as June 2015. If the court does not act on the stay application, the ruling could come "effectively too late to prevent irreparable harm to Teva," the lawyers said.
The stay application was directed to Chief Justice John Roberts. He is likely to ask the other litigants for a response before deciding how to proceed.
Teva is currently trying to switch patients over to a new version of Copaxone, which is the company's most important product.
The case is Teva v. Sandoz, U.S. Supreme Court, 13-854.
Source: Reuters © Thomson Reuters 2014 (09/04/13)
As the world’s largest maker of generic drugs, Teva Pharmaceutical Industries has been critical of brand-name manufacturers that try to block generic versions of their high-priced medicines.
But Teva is now emulating its rivals, mounting an aggressive effort to stave off generic versions of Copaxone, its big-selling brand-name drug for multiple sclerosis, which is set to lose patent protection late in May.
On Monday, Teva got help from the United States Supreme Court, which agreed to hear its appeal of a lower-court ruling that invalidated a patent that would have protected Copaxone until September 2015.
Teva, based in Israel, is desperate to stave off generic competition to Copaxone, which had global sales last year of $4.3 billion; $3.2 billion of that figure came from the United States. The drug, which has been on the market for 17 years and is the best-selling treatment for M.S., accounts for about 20 percent of Teva’s revenue and about half its profit.
But a generic version of Copaxone could provide needed cost relief to the health care system. The list prices of Copaxone and other older M.S. drugs have roughly quadrupled over the last decade, to about $60,000 a year.
“The prices would go up 10, 20, 30 percent at a time for no apparent reason,” said Dr. John R. Corboy, co-director of the Rocky Mountain Multiple Sclerosis Center at the University of Colorado. “We spend a quarter, some days half our time talking to patients about insurance and figuring out how we are going to get them medications.”
At the same time, Teva has been frantically trying to convert patients to a new, more concentrated form of Copaxone that requires patients to inject themselves only three times a week instead of every day. That new form would not be subject to generic competition. Once patients convert, it would be harder for insurers to force them to use a generic that would require them to go back to daily injections.
Teva has also submitted one petition after another to the Food and Drug Administration claiming, in essence, that Copaxone has such a complex makeup that it is virtually impossible to demonstrate that a copy is the same as the original. Subtle differences could make a generic less effective or even dangerous.
Ten years ago, Aventis, now part of Sanofi, made the same complexity argument about its blood thinner Lovenox.
In that case, Teva was on the other side, trying to introduce a generic. It accused Aventis of “blatant and unjustified efforts” to deny consumers “the cost savings associated with robust and fair generic competition.” The F.D.A. approved Teva’s generic.
Teva says Copaxone, which is known generically as glatiramer acetate, is more complex than Lovenox. It rejected suggestions it was being hypocritical in trying to block generic versions of Copaxone.
“I think it would be hypocritical if there would not be quality and efficacy and safety issues for patients here,” Dr. Robert Koremans, president of Teva’s specialty medicines division, said in an interview.
Copaxone is made up of four amino acids linked in chains of various sizes and sequences. It is not clear how the drug works, but it does reduce the frequency of M.S. relapses. The disease results from attacks on the protective covering of nerves by the body’s own immune system, causing symptoms like blurred vision and difficulty walking.
The F.D.A. has not yet approved a generic version of Copaxone, perhaps because of its complexity. But two teams have said they are confident the agency will approve their drugs as early as May. One team consists of Momenta Pharmaceuticals and Sandoz, the generic arm of Novartis. The other is Mylan and Natco Pharma.
The companies declined to comment Monday on whether they would still start selling their drugs given the Supreme Court’s decision to hear Teva’s appeal. But Craig A. Wheeler, the chief executive of Momenta, said last week that it “shouldn’t change things in my view.”
Sailesh K. Patel, an intellectual property lawyer in Chicago who is not involved in this case, said the generic companies could face damages if they market their products now and Teva ultimately prevails.
Even if the generics get to market by late May, Teva hopes by then to have converted 30,000 of the roughly 85,000 American Copaxone users to the new version of Copaxone, which was approved by the F.D.A. in late January.
To do that, Teva has expanded the staff of its patient support operation, Shared Solutions. The organization has made “thousands of phone calls” to patients and doctors, Dr. Michael Hayden, Teva’s chief scientific officer, said at an investor conference in late February.
Shared Solutions has also been holding complimentary dinners for patients. Two patients who attended a buffet dinner at a Mexican restaurant in Downey, Calif., on Thursday said they would switch to the new Copaxone, enticed by having only three injections a week.
“I just signed my paper right now,” said one of them, who gave her name only as Linda A.
Teva has set the price of the new Copaxone at $4,641 a month, lower than the older, daily version, which costs $5,060 monthly.
The conversion is “nicely ahead of plan,” Dr. Koremans said.
But there is some resistance. Excellus BlueCross BlueShield in upstate New York is requiring that a switch to the new Copaxone be medically necessary, not just for convenience. It hopes to keep patients on the daily version so their prescriptions would be automatically switched to a generic, saving employers money.
In six petitions to the F.D.A. since 2008 Teva has said, among other things, that generics should not be approved without clinical trials, something not usually required.
Synthon, a Dutch company that is developing a generic, just completed such a trial showing its drug was as good as Copaxone in reducing brain lesions. Synthon says European regulators want such trials. But the F.D.A. has not required them.
Source: The New York Times © 2014 The New York Times Company (01/04/14)
Synthon announces successful outcome of the Phase III GATE study with its generic glatiramer acetate(27/03/14)
NIJMEGEN, the Netherlands--(BUSINESS WIRE)--Synthon today announced that the company’s glatiramer acetate met the main endpoint of a late-stage study in patients with relapsing remitting multiple sclerosis (RRMS). The Phase III Glatiramer Acetate clinical trial To assess Equivalence with Copaxone®* (GATE) is to-date the only Phase III study conducted with a generic version of Copaxone® and has demonstrated an equivalent efficacy and safety profile for Synthon’s glatiramer acetate compared to Copaxone®.
GATE was set up following Scientific Advice received from the European Medicines Agency (EMA) with the aim to show equivalence of Synthon’s glatiramer acetate (Synthon GTR) with Teva’s Copaxone® in a well-controlled 3-arm double-blind study that was also designed to show superiority of the two active treatment groups over placebo. The large-scale, multicenter study consists of a nine-month double-blind efficacy comparison followed by a currently ongoing 15-month open-label extension and runs in Europe (including Russia, Ukraine and Belarus), Mexico, South Africa and the United States. “The data gathered during the double-blind part of the study present a solid basis for the regulatory submission in Europe in order to make an equivalent alternative to Copaxone® available to patients suffering from multiple sclerosis”, commented Jacques Lemmens, Synthon’s chief executive officer.
In the GATE study 796 patients with active RRMS were randomized to daily injections of Synthon’s glatiramer acetate (20 mg/ml), Copaxone® (20 mg/ml) or matching placebo for a double-blind 9-month treatment period. Primary endpoint of the study was the number of T1 gadolinium enhancing brain lesions on MRI assessed after 7, 8 and 9 months of treatment which were convincingly shown to be equally reduced in both the Synthon GTR as well as the Copaxone® treatment groups and significantly reduced compared to placebo. Other outcomes, including the incidence of MS relapses, disability, and patient reported tolerability, support the primary conclusion of the study. Safety analyses showed a comparable incidence of reported adverse reactions between both active glatiramer acetate groups.
Following the double-blind phase of the trial, patients in the Copaxone® and placebo groups of the GATE study switched over to Synthon GTR and are continuing Synthon GTR treatment for another 15-month period, as are the patients in the Synthon GTR arm of the study. This part of the study is expected to further confirm efficacy and safety of long-term Synthon GTR treatment as well as to provide evidence supporting the safety of switching therapies from Copaxone® to Synthon’s GTR. Jeffrey Cohen, M.D., Professor in the Cleveland Clinic Lerner College of Medicine, Director of Experimental Therapeutics at the Cleveland Clinic Mellen MS Center, and Chair of the GATE Steering Committee, remarked that “these are important results. The mechanism of action of Copaxone® is not fully understood and the resulting complexity of developing a generic alternative/version is broadly acknowledged. Clinically proven equivalence will ensure that patients with multiple sclerosis are provided with an effective and safe alternative.”
Concludes Lemmens: “Glatiramer acetate is the first anticipated generic version of an approved MS product in the United States and the European Union. The future availability of a generic of Copaxone® means that MS treatments – which currently cost between USD 30,000-60,000 per patient per year – will become more affordable, thereby allowing more MS patients around the world to have access to this medication.”
Full details of the study will be submitted for publication in a peer-reviewed medical journal and presented at future scientific meetings.
Synthon has already submitted an Abbreviated New Drug Application (ANDA) for glatiramer acetate, 20 mg/ml solution for injection in pre-filled syringes to the United States FDA in November 2011.
*Copaxone® is a registered trademark of Teva Pharmaceutical Industries Ltd.
Source: ©2014 Business Wire (27/03/14)
The U.S. Supreme Court deferred a decision on whether to hear an appeal by Teva Pharmaceutical Industries Ltd. that aims to delay generic competition to its top-selling Copaxone multiple-sclerosis drug.
The justices took no action on Teva’s bid for a hearing and are now scheduled to consider the case at their March 21 private conference, according to the court’s public docket.
Teva is seeking to revive a patent that would protect Copaxone from generic rivals until September 2015. Without that patent, Teva will lose legal protection this May on Copaxone, which brings in $3.2 billion in annual U.S. sales and accounts for more than half the company’s profit.
Teva is battling drugmakers that are planning to offer generic versions in May: Momenta Pharmaceuticals Inc, which has developed a version with Novartis AG’s Sandoz, and Mylan Inc.
The court issued a list of orders today from its March 7 conference. The Teva case was originally scheduled for consideration at that conference. The court, which often defers decisions on pending appeals, is scheduled to issue its next set of orders on March 24.
A ruling last year by the U.S. Court of Appeals for the Federal Circuit upheld four Teva patents that expire in May while invalidating a separate patent that would have blocked generic competition until September 2015.
In November, Chief Justice John Roberts refused to put the Federal Circuit ruling on hold while the high court decided whether to take up Teva’s appeal.
The case is Teva v. Sandoz, 13-854.
Source: Bloomberg ©2014 BLOOMBERG L.P (11/03/14)