CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Genzyme, a Sanofi Company (EURONEXT: SAN and NYSE: SNY), announced today interim results from the first year of the extension study of LEMTRADA (alemtuzumab), being developed for the treatment for multiple sclerosis (MS). In this analysis of the first year of the extension study, relapse rates and sustained accumulation of disability remained low among patients who had previously received LEMTRADA in either of the Phase III CARE-MS I and CARE-MS II studies. In these pivotal studies, LEMTRADA was given as two annual courses, at the start of the study and 12 months later. More than 80 percent of patients did not receive further treatment with LEMTRADA during the first year of the extension study. These findings are important because they suggest that the benefits of LEMTRADA as observed in the Phase III studies are maintained, even though most patients did not receive further dosing, said Edward Fox, M.D., Director of the Multiple Sclerosis Clinic of Central Texas, who presented the study results today at the annual meeting of the American Academy of Neurology in San Diego, Calif. Extension Study Results The Phase III trials of LEMTRADA were randomized, two-year pivotal studies comparing treatment with LEMTRADA to Rebif … Continue reading →

Sanofi wins backing for multiple sclerosis tablet. Photograph: Reuters Sanofi won backing from a European advisory panel for its first multiple sclerosis therapy, the tablet Aubagio, a step forward in the French drugmaker's plan to grab a slice of the $14 billion MS business. Aubagio, a once-daily pill, was recommended for treatment of relapsing forms of the debilitating disease by the European Medicines Agency's Committee for Medicinal Products for Human Use, the London-based agency said today. The committee decided that the medicine's key ingredient, known as teriflunomide, couldn't be considered as a new active substance, the EMA said. The decision not to grant new active substance status to Aubagio "isn't likely to have much of an impact", Vincent Meunier, an analyst at Exane BNP Paribas in Paris, who has a buy recommendation on the stock, said. "The one risk is that a company decides to work on a generic version of the medicine, but Aubagio isn't a huge product for Sanofi." Sanofi won US backing to sell the tablet in September. The company has been building up an MS business since its 2011 purchase of the US biotech company Genzyme, which gave it access to Lemtrada, another experimental treatment for … Continue reading →

Multiple Sclerosis is an autoimmune disease that affects the central nervous system. Mostly it strikes between the ages of 20 and 40, but can be exhibited at any age. More women have the disease than men, and it may have a genetic connection. Health officials think it may be related to a virus that lies dormant in cells. MS is caused by damage to the myelin sheath, the protective covering that surrounds nerve cells. When covering is damaged, nerve signals slow down or stop. Nerve damage is caused by inflammation that occurs when the bodys immune cells attack the nervous system. This can occur along any area of the brain, optic nerve and spinal cord. Scar tissue develops where the myelin is damaged and this is what disrupts nerve messages. Symptoms may abate ,and remissions last for months or years. More damage is done with each episode. No cure has been found, but therapies can slow the diseases progress. Treatment can control symptoms. Treatments include drugs to reduce muscle spasms and urinary problems; antidepressants and drugs to reduce fatigue. Diagnosing MS often is a tedious process of eliminating other possibilities. A CT scan and an MRI may help physicians decide … Continue reading →

By Chris Reidy, Globe Staff A panel that advises European regulators has issued a positive opinion on a multiple sclerosis drug candidate from Biogen Idec Inc. A Weston company known for such MS drugs as Avonex and Tysabri, Biogen Idec said in a Friday press release that it has received a positive opinion on its MS drug candidate Tecfidera from the Committee for Medicinal Products for Human Use, or CHMP. The CHMP is recommending that European Union regulators grant market authorization for Tecfidera as a first-line oral treatment for adults with relapsing-remitting multiple sclerosis. A decision on Tecfidera by the US Food and Drug Administration is expected shortly. We believe Tecfidera will raise expectations for what people living with MS can achieve with their therapy, Biogen Idec chief executive George A. Scangos said in a statement. Earlier this week, Biogen Idec announced that the US Patent Office had granted it broad protection for Tecfidera. Avonex is typically injected once a week. Tysabi is generally taken by infusion once a month. And Tecfidera is envisioned as a capsule that patients would take twice a day. Meanwhile, Genzyme, now a Cambridge-based unit of French drug maker Sanofi SA, also said that the … Continue reading →