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TEMSO study for Aubagio in Multiple Sclerosis is published in NEJM Central Nervous System Page

The pivotal Phase III TEMSO study with investigational once-daily oral medication Aubagio (teriflunomide) from Sanofi/Genzyme is published in The New England Journal of Medicine (NEJM). Results showed that teriflunomide at the 14mg dosage significantly reduced the annual relapse rate, reduced disability progressions and improved several magnetic resonance imaging (MRI) measures of disease activity, including new or worsening brain lesions in relapsing, remitting Multiple Sclerosis. Teriflunomide has a well-characterized safety profile, with a similar proportion of trial participants reporting adverse events compared to placebo. Teriflunomide has been filed with the FDA in August of 2011 and the EMA filing is expected in the first quarter of 2012. see Randomized Trial of Oral Teriflunomide for Relapsing Multiple Sclerosis Paul O'Connor, M.D., et al for the TEMSO Trial Group N Engl J Med 2011; 365:1293-1303 October 6, 2011.

Tysabri shows benefits in Multiple Sclerosis patients Central Nervous System Page

Patients with Multiple Sclerosis who take anti-inflammatory Tysabri (natalizumab), from Biogen and Elan, for two years showed a reduced risk of experiencing at least one relapse (at 2 years this was reduced by 40%). The study also showed that the number of patients whose disability progressed in the time interval was reduced by 25%. In addition, MRI scans showed evidence that treatment with Tysabri reduced disease activity. Treatment also created some side effects including limb swelling, rigors, vaginal inflammation and menstrual disorders and 2 patients treated with Tysabri for more than 2 years developed Progressive Multifocal Leukoencephalopathy, a rare and often fatal viral disease. In light of this, the researchers recommend further studies. The review was published in The Cochrane Database of Systematic Reviews: "Natalizumab for relapsing remitting multiple sclerosis" by Eugenio Pucci et al. Issue 105 OCT 2011.Tysabri is approved in the USA and EU.

Lemtrada and Aubagio trials to report at ECTRIMS/ACTRIMS congress Central Nervous System Page

Genzyme/Sanofi will report more than 20 abstracts at ECTRIMS/ACTRIMS congress. Data will include Phase III results of Lemtrada(alemutuzumab) and Aubagio ( oral teriflunomide) in relapsing remitting Multiple Sclerosis (MS) including CARE-MS 1 study comparing Lemtrada and Rebif (interferon beta 1-a) in relapsing remitting MS and five year extension of TEMSO study of oral Aubagio (Poster 924) and efficacy of Aubagio (Poster 438) and long term results for Lemtrada CARE-MS Phase II trial (Poster 928) and four year efficacy of Lemtrada in MS (Poster 931). Lemtrada is being developed by Genzyme/Sanofi in the USA and Bayer HealthCare in the EU.

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