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Labels: Aubagio, Betaseron, Copaxone, Gilenya, Lemtrada, Rebif, Rituxan-Rituximab, TECFIDERA, Tysabri

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Labels: Aubagio, Betaseron, Copaxone, Extavia, Gilenya, Lemtrada, Rebif, Rituxan-Rituximab, TECFIDERA, Tysabri

The U.S. Food and Drug Administration said Sanofi’s Genzyme unit didn’t submit evidence from “adequate and well-controlled studies” showing that the benefits of Lemtrada outweigh its side effects, the Paris-based company said in a statement today. Sanofi disagrees with the conclusion and said it will appeal.

Lemtrada, which was approved in the European Union in September, was a key part of Sanofi’s $20.1 billion acquisition of Genzyme in 2011. The FDA indicated one or more additional trials comparing Lemtrada with another drug are needed for approval, Sanofi said. That would delay the product’s entry to a market dominated by Teva Pharmaceutical Industries Ltd. (TEVA:US)’s Copaxone, Biogen Idec Inc. (BIIB:US)’s Tecfidera, Avonex and Tysabri, Novartis AG’s (NOVN) Gilenya and Merck KGaA’s Rebif.
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Labels: Copaxone, Gilenya, Lemtrada, Rebif, TECFIDERA, Tysabri

BioTrends Research Group, a research and advisory firms for specialized biopharmaceutical issues, finds that physician-reported patient shares for Novartis's Gilenya and Biogen Idec's Tysabri are 8 percent and 10 percent among relapsing-remitting multiple sclerosis (RR-MS) patients treated with a disease-modifying therapy (DMT) across the EU5 (France, Germany, Italy, Spain and the United Kingdom); significantly higher than those reported by EU5 neurologists surveyed in 2012.
According to a release, surveyed neurologists also report that recent changes in treatment management include a shift toward earlier and more-aggressive treatment and increased use of the anti- JCV antibody assay, changes that are consistent with the increased patient shares reported for Gilenya and Tysabri. Survey data indicate that these agents occupy distinct niches, with Gilenya a preferred second-line therapy in JCV-positive patients and Tysabri a preferred second-line therapy in JCV-negative patients.

The TreatmentTrends: Multiple Sclerosis (EU) 2013 report finds that, despite fewer than 30 percent of surveyed neurologists reporting access to Genzyme's* Aubagio and Genzyme/Bayer HealthCare's Lemtrada--and given the limited time these agents had been available at the time the survey was fielded--these DMTs have nevertheless captured a 1 percent physician-reported weighted MS patient share. The data also reveal that surveyed neurologists anticipate substantial changes in DMT use in the coming months as access to Aubagio and Lemtrada expands and as new products, notably Biogen Idec's Tecfidera, become available. Neurologists indicate that Aubagio will most likely compete with first-line products (i.e., Biogen Idec's Avonex, Bayer HealthCare's Betaferon and Teva's Copaxone), while Tecfidera may replace these products as well as Merck Serono's Rebif and Gilenya. Lemtrada, conversely, will most likely compete with Tysabri or would not replace an existing DMT, suggesting anticipated use as a last-line therapy.

"The European MS market is entering a dynamic period with two recent DMT launches and as many as six new DMTs launching in the next five years," said Decision Resources Group Senior Business Insights Analyst Georgiana L. Kuhlmann, S.M. "Our data find that gains for new brands will likely come at the expense of the interferon-beta therapies and Copaxone."

BioTrends Research Group provides syndicated and custom primary market research to pharmaceutical manufacturers competing in clinically evolving, specialty pharmaceutical markets.
Decision Resources Group is a cohesive portfolio of companies that offers information and insights on sectors of the healthcare industry.
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Labels: Aubagio, Betaseron, Copaxone, Gilenya, Lemtrada, Rebif, TECFIDERA, Tysabri

The TreatmentTrends: Multiple Sclerosis (EU) 2013 report finds that, despite fewer than 30 percent of surveyed neurologists reporting access to Genzyme's* Aubagio and Genzyme/Bayer HealthCare's Lemtrada—and given the limited time these agents had been available at the time the survey was fielded—these DMTs have nevertheless captured a 1 percent physician-reported weighted MS patient share. The data also reveal that surveyed neurologists anticipate substantial changes in DMT use in the coming months as access to Aubagio and Lemtrada expands and as new products, notably Biogen Idec's Tecfidera, become available. Neurologists indicate that Aubagio will most likely compete with first-line products (i.e., Biogen Idec's Avonex, Bayer HealthCare's Betaferon and Teva's Copaxone), while  Tecfidera may replace these products as well as Merck Serono's Rebif and Gilenya. Lemtrada, conversely, will most likely compete with Tysabri or would not replace an existing DMT, suggesting anticipated use as a last-line therapy.

Labels: Aubagio, Copaxone, Gilenya, Lemtrada, Rebif, TECFIDERA, Tysabri

An FDA advisory panel recently recommended the approval of Sanofi's multiple sclerosis drug, Lemtrada. However, that approval came among some mixed and contradictory opinions about the drug and the efficacy of Sanofi's trials.

On Nov. 13, the FDA panel voted 12-6 that Sanofi had provided enough evidence of Lemtrada's efficacy in patients with relapsed MS, but at the same time voted 11-6 that the company's trials had not been conducted thoroughly enough to properly assess the drug. After those seemingly contradictory opinions, the panel voted 14-0 that the drug should still be approved in December, despite its potential to cause cancer and other problems.

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Labels: Aubagio, Copaxone, Gilenya, Lemtrada, TECFIDERA, Tysabri

Recognizing the need for better treatment options, big pharma has a slate of new oral MS drugs hitting the market.
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Labels: Aubagio, Copaxone, Gilenya, Lemtrada, TECFIDERA, Tysabri

Currently existing immunomodulatory drugs that treat Multiple Sclerosis only work to treat relapse or attacks, manage symptoms, or modify the course of the disease.  These drugs have too many side effects due to their lack of target specificity. Another class of drugs, recently being developed, are protein based therapies (monoclonal antibodies or mAbs) that are more target specific and cause less damage to the body.
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Labels: Aubagio, Betaseron, Lemtrada, Rebif, TECFIDERA, Tysabri