New longer-term data on Genzyme's relapsing MS treatments to be presented at AAN 2015

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Reviewed

Apr 15 2015

30 Presentations Planned On Marketed Products and New Data from Company’s MS Pipeline

Genzyme, a Sanofi company, announced today that new longer-term data on its relapsing multiple sclerosis treatments, Aubagio^®(teriflunomide) and Lemtrada^® (alemtuzumab), will be featured during the 67^th annual meeting of the American Academy of Neurology (AAN) being held in Washington, D.C. April 18-25. The company will present 30 platform and poster presentations from its MS franchise, including 19 on Lemtrada, 10 on Aubagio and one pipeline presentation. Key data being presented at AAN include:

12-Year Clinical Efficacy and Safety Data for Teriflunomide: Results from a Phase 2 Extension Study (Poster Session – P7.223; April 23; 2:00 – 6:30 p.m. EDT)
Assessing Comparative Outcomes from Teriflunomide and Dimethyl Fumarate Studies in Relapsing MS: Use of “Number Needed to Treat” Analysis (Poster Session – P3.245; April 21; 2:00 – 6:30 p.m. EDT)
Durable Effect of Alemtuzumab on MRI Activity in Treatment-Naive Active Relapsing-Remitting Multiple Sclerosis Patients: 4-Year Follow-up of CARE-MS I (Poster Session – P7.246; April 23; 2:00 – 6:30 p.m. EDT)
Durable Effect of Alemtuzumab on MRI Outcomes in Patients With Relapsing-Remitting Multiple Sclerosis Who Relapsed on Prior Therapy: 4-Year Follow-up of CARE-MS II (Poster Session – P7.249; April 23; 2:00 – 6:30 p.m. EDT)
Alemtuzumab Slows Brain Volume Loss Over 4 Years Despite Most Relapsing-Remitting Multiple Sclerosis Patients Not Receiving Treatment for 3 Years (Poster Session – P7.263; April 23; 2:00 – 6:30 p.m. EDT)
Characterization of a Next Generation Anti-CD52 Antibody (Platform Session – S20.006; April 22; 3:15 p.m. EDT)

Genzyme’s MS R&D pipeline is focused on investigational treatments to help address unmet needs for relapsing and progressive forms of MS through research in selective immunomodulation, neuroprotection and remyelination. The investigational anti-CD52 antibody GZ402668 is currently in a Phase 1 trial in MS patients, including intravenous and subcutaneous administration. Genzyme is also developing vatelizumab, an investigational anti-VLA-2 humanized monoclonal antibody currently in a Phase 2 trial for relapsing forms of MS.

“The data we’re presenting at AAN this year help address important scientific questions about Aubagio and Lemtrada over the long-term, and in comparison with other therapies,” said Bill Sibold, Head of Genzyme’s Multiple Sclerosis business. “We’re also very excited to share some additional findings on the next generation of potential Genzyme MS therapies. Our presence at AAN demonstrates our long-term commitment to the MS community, and our continued focus to address unmet needs for people living with MS.”

The list of Genzyme’s additional presentations at AAN is as follows, along with information about company-sponsored activities.

Aubagio:

Teriflunomide Shows Consistent Clinical Efficacy on Severe Relapses across Two Phase 3 Trials in Patients with Relapsing forms of Multiple Sclerosis, TEMSO and TOWER (Poster Session – P7.212; April 23; 2:00 – 6:30 p.m. EDT)
Teriflunomide Significantly Increased Time to First Relapse in TEMSO, TOWER and TOPIC (Poster Session – P7.279; April 23; 2:00 – 6:30 p.m. EDT)
Positive MRI Outcomes in Patients with Early Multiple Sclerosis Treated with Teriflunomide: Subgroup Analyses from the TOPIC Phase 3 Study (Poster Session – P7.253; April 23; 2:00 – 6:30 p.m. EDT)
The Clinical Course of Hair Thinning Associated with Teriflunomide: Case Series of Patients Who Participated in a Hair Photography Project (Poster Session – eP7.016; April 23; 2:00 – 6:30 p.m. EDT)
How Satisfied with Their Treatment Are Patients with MS? Psychometric Evaluation of the Treatment Satisfaction Questionnaire for Medication (TSQM) (Poster Session – P3.236; April 21; 2:00 – 6:30 p.m. EDT)
Safety and Efficacy of Teriflunomide in Patients Switching from Subcutaneous Interferon Beta-1a (Poster Session – P7.275; April 23; 2:00 – 6:30 p.m. EDT)
Efficacy of Teriflunomide in Early-Stage MS: Reanalysis of the TOPIC Study Using 2010 McDonald Diagnostic Criteria (Poster Session – P7.274; April 23; 2:00 – 6:30 p.m. EDT)
Pooled Safety Analyses from Teriflunomide Clinical Studies (Poster Session – P7.268; April 23; 2:00 – 6:30 p.m. EDT)

Lemtrada:

Durable Effect of Alemtuzumab on Clinical Outcomes in Treatment-Naive Relapsing-Remitting Multiple Sclerosis Patients: 4-Year Follow-up of CARE-MS I (Platform Session – S4.007; April 21; 2:30 p.m. EDT)
Durable Effect of Alemtuzumab on Clinical Outcomes in Patients With Relapsing-Remitting Multiple Sclerosis Who Relapsed on Prior Therapy: 4-Year Follow-up of CARE-MS II (Poster Session – P7.276; April 23; 2:00 – 6:30 p.m. EDT)
Switching to Alemtuzumab From Subcutaneous Interferon Beta-1a After CARE-MS I Further Improved MRI Outcomes in Patients With Relapsing-Remitting Multiple Sclerosis (Poster Session – P7.261; April 23; 2:00 – 6:30 p.m. EDT)
Switching to Alemtuzumab From Subcutaneous Interferon Beta-1a After CARE-MS II Further Improved MRI Outcomes in Patients With Relapsing-Remitting Multiple Sclerosis (Poster Session – P7.248; April 23; 2:00 – 6:30 p.m. EDT)
Improvement in Disability With Alemtuzumab Is Associated With Quality of Life Improvement Over 3 Years in Patients Who Relapsed on Prior Therapy (Poster Session – P3.260; April 21; 2:00 – 6:30 p.m. EDT)
Durable Effect of Alemtuzumab on Disability Improvement in Patients With Relapsing-Remitting Multiple Sclerosis Who Relapsed on a Prior Therapy (Poster Session – P3.261; April 21; 2:00 – 6:30 p.m. EDT)
Durable Efficacy of Alemtuzumab in Patients With Highly Active Relapsing-Remitting Multiple Sclerosis Who Relapsed on a Prior Therapy (Poster Session – P7.269; April 23; 2:00 – 6:30 p.m. EDT)
Slowing of Brain Volume Loss in Patients With Relapsing-Remitting Multiple Sclerosis After Switching From Subcutaneous Interferon Beta-1a to Alemtuzumab (Poster Session – P7.264; April 23; 2:00 – 6:30 p.m. EDT)
Improvement in Clinical Outcomes in Treatment-Naive Relapsing-Remitting Multiple Sclerosis Patients Who Switched From Subcutaneous Interferon Beta-1a to Alemtuzumab (Poster Session – P7.270; April 23; 2:00 – 6:30 p.m. EDT)
Improvement in Clinical Outcomes Following Switch From Subcutaneous Interferon Beta-1a to Alemtuzumab: CARE-MS II Extension Study (Poster Session – P7.278; April 23; 2:00 – 6:30 p.m. EDT)
The Efficacy of Alemtuzumab Is Maintained in Patients Who Develop Thyroid Adverse Events (Poster Session – P7.272; April 23; 2:00 – 6:30 p.m. EDT)
Incidence of Infection Decreases Over Time in Alemtuzumab-Treated Patients With Relapsing-Remitting Multiple Sclerosis: 4-Year Follow-up of the CARE-MS Studies (Poster Session – P7.265; April 23; 2:00 – 6:30 p.m. EDT)
Administration of Alemtuzumab on Nonconsecutive Days Does Not Impact Infusion-Associated Reactions, Efficacy, or Lymphocyte Depletion (Poster Session – P7.277; April 23; 2:00 – 6:30 p.m. EDT)
A Phase 3b/4 Long-Term Study of Alemtuzumab in Patients With Relapsing-Remitting Multiple Sclerosis: TOPAZ Study Design (Poster Session – P7.219; April 23; 2:00 – 6:30 p.m. EDT)
Evaluation of Comprehensive Alemtuzumab Infusion Guidance in Patients With Relapsing-Remitting Multiple Sclerosis: EMERALD Study Design (Poster Session – P7.283; April 23; 2:00 – 6:30 p.m. EDT)
Design of a Non-interventional Study to Establish Effectiveness, Quality of Life, Cognition, Health-Related and Work Capacity Data on Alemtuzumab in Multiple Sclerosis Patients in Germany (TREAT-MS) (Poster Session – P7.281; April 23; 2:00 – 6:30 p.m. EDT)