New data from Genzyme's AUBAGIO and LEMTRADA clinical trials to be presented at ECTRIMS

Oct 9 2012

Genzyme, a Sanofi company (EURONEXT: SAN and NYSE: SNY), announced today new data from Genzyme's clinical development programs for AUBAGIO^® (teriflunomide) and LEMTRADA^TM (alemtuzumab) will be presented at the 28^th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Lyon, France, October 10-13.    

"The data to be presented at ECTRIMS are a reflection not only of the comprehensive clinical development programs supporting AUBAGIO and LEMTRADA, but of the unique commitment and substantial progress Genzyme has made to date in bringing forward differentiated therapies in multiple sclerosis," said Genzyme CEO and President, David Meeker.

Once-daily, oral AUBAGIO is now commercially available in the U.S. following FDA approval in patients with relapsing forms of MS. Marketing applications for AUBAGIO and LEMTRADA are currently under review by the EMA and other regulatory authorities.

Key data from across the company's clinical development programs to be presented are as follows. Abstracts are available on the ECTRIMS website.

TOWER (Teriflunomide Oral in people With relapsing multiplE scleRosis)

TOWER is a randomized Phase III trial assessing once-daily oral AUBAGIO (teriflunomide) in patients with relapsing multiple sclerosis. It is the second Phase III study for AUBAGIO.

• The efficacy and safety of teriflunomide in patients with relapsing MS: results from TOWER, a phase III, placebo-controlled study (Parallel Session 12 - 153; October 12; 3:10 p.m. CEST, 9:10 a.m. EDT).

CARE-MS II (Comparison of Alemtuzumab and Rebif Efficacy in Multiple Sclerosis II)

CARE-MS II was a randomized Phase III clinical trial designed to evaluate whether the investigational MS therapy LEMTRADA (alemtuzumab) could achieve meaningful efficacy and safety improvements over the approved, active comparator Rebif (subcutaneous interferon beta-1a 44 mcg).

• Efficacy of alemtuzumab in relapsing-remitting multiple sclerosis patients who relapsed on prior therapy: subgroup analyses by previous DMT use (Poster Session 1 - P483; October 11; 3:30 p.m. CEST, 9:30 a.m. EDT).
• Disability improvement with alemtuzumab vs. interferon beta-1a in relapsing-remitting multiple sclerosis patients who relapsed on prior therapy (Poster Session 2 - P922; October 12; 3:30 p.m. CEST, 9:30 a.m. EDT).
• Effect of alemtuzumab vs. Rebif® on brain MRI measurements: Results of CARE-MS II (Poster Session 2 - P877; October 12; 3:30 p.m. CEST, 9:30 a.m. EDT).
• Safety of alemtuzumab in relapsing-remitting multiple sclerosis patients who relapsed on prior therapy (Poster Session 1 - P545; October 11; 3:30 p.m. CEST, 9:30 a.m. EDT).

Additional Genzyme MS portfolio data, in addition to the Genzyme satellite symposia to be featured at ECTRIMS include:

AUBAGIO:

• Magnetic resonance imaging as a surrogate for clinical endpoints in multiple sclerosis (Poster Session 2 - P1014; October 12; 3:30 p.m. CEST, 9:30 a.m. EDT).
• Teriflunomide treatment of human monocyte-derived dendritic cells in vitro does not impair their maturation or ability to induce allogeneic T-cell responses (Poster Session 2 - P950; October 12; 3:30 p.m. CEST, 9:30 a.m. EDT).
• Effect of teriflunomide on immune responses to seasonal influenza vaccination in patients with relapsing multiple sclerosis: results from the TERIVA study (Poster Session 2 - P925; October 12; 3:30 p.m. CEST, 9:30 a.m. EDT).
• Effect of teriflunomide on the pharmacodynamic and pharmacokinetic profiles of warfarin in healthy male subjects (Poster Session 1 - P453; October 11; 3:30 p.m. CEST, 9:30 a.m. EDT).
• Pregnancy outcomes from the teriflunomide clinical development programme: retrospective analysis of the teriflunomide clinical trial database (Poster Session 2 - P737; October 12; 3:30 p.m. CEST, 9:30 a.m. EDT).
• Effect of teriflunomide on lymphocyte and neutrophil levels in patients with relapsing multiple sclerosis: results from the TEMSO study (Poster Session 2 - P995; October 12; 3:30 p.m. CEST, 9:30 a.m. EDT).

LEMTRADA:

• Autoimmunity in patients treated with alemtuzumab for relapsing-remitting multiple sclerosis (Poster Session 2 - P1005; October 12; 3:30 p.m. CEST, 9:30 a.m. EDT).
• Lymphocyte subset dynamics following alemtuzumab treatment in the CARE-MS I study (Poster Session 2 - P935; October 12; 3:30 p.m. CEST, 9:30 a.m. EDT).
• Therapeutic treatment with an anti-mouse CD52 antibody reverses disease symptoms in a murine EAE model of multiple sclerosis (Poster Session 2 - P908; October 12; 3:30 p.m. CEST, 9:30 a.m. EDT).