Genzyme’s Aubagio, Lemtrada MS Therapies To Showcase at Conference

During the 30th Congress of the European Committee for Research and Treatment in Multiple Sclerosis (ECTRIMS) taking place in Boston between September 10th and 13th, Genzyme, a Sanofi company, will present its multiple sclerosis (MS) pipeline with a new group of trial treatments for early development of MS.

Genzyme is a pioneer in the development and delivery of transformative therapies focusing mainly on rare diseases and multiple sclerosis for more than 30 years. These transformative therapies, commercialized worldwide, having in many cases proven to be revolutionary and have had a high positive impact on the lives of the patients. The hope this year is that Genzyme will continue to advance new therapies for MS.

At this year’s ECTRIMS, the company will also present 26 oral and poster presentations from its MS franchise, including four-year results from the Lemtrada™ (alemtuzumab) extension study, i.e. “Efficacy and safety of alemtuzumab in treatment-naive patients with relapsing-remitting ms: four-year follow-up of the CARE-MS I study”(Poster Session 1 – P090; Sept. 11; 3:30 – 5:00 p.m. EDT) and “Efficacy and safety of alemtuzumab in patients with relapsing-remitting ms who relapsed on prior therapy: four-year follow-up of the CARE-MS II study.” (Poster Session 1 – P043; Sept. 11; 3:30 – 5:00 p.m. EDT), 12-year MRI data for Aubagio®(teriflunomide), i.e. “Long-term MRI outcomes from patients treated with teriflunomide: results from a phase 2 extension study.” (Poster Session 1 – P079; Sept. 11; 3:30 – 5:00 p.m. EDT), and results from the Aubagio TOPIC study, i.e. “Efficacy of teriflunomide in patients with early stage MS: analysis of the TOPIC study using 2010 McDonald diagnostic criteria.” (Poster Session 1 – P095; Sept. 11; 3:30 – 5:00 p.m. EDT) and “MRI outcomes in patients with early multiple sclerosis treated with teriflunomide: subgroup analyses from the TOPIC phase 3 study.” (Poster Session 1 – P040; Sept. 11; 3:30 – 5:00 p.m. EDT), recently published in The Lancet Neurology.

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Genzyme also develops research programs and collaborations in clinical and preclinical studies on agents that selective target immunomodulation, neuroprotection and remyelination processes that are important to address therapeutic needs for relapsing and progressive forms of MS. These include, for example:

• Vatelizumab – anti-very late activation antigen 2 (VLA-2) humanized monoclonal antibody currently in a Phase II trial for relapsing forms of MS, in partnership with Glenmark Pharmaceuticals.
• GZ402668 – A next-generation investigational  anti-CD52 humanized monoclonal antibody currently approaching Phase I  clinical development.
• Discovery and research programs evaluating agents promoting remyelination, targeting innate immune cells at central nervous system to provide neuroprotection.
• Collaborations with academic medical  centers such as Brigham and Women’s Hospital and Cleveland Clinic to identify,  respectively, correlative biomarkers of disease progression and to explore strategies to address neurodegeneration, a hallmark of progressive MS.

“Since FDA approval of once-daily oral Aubagio two years ago, Genzyme has continued to advance the understanding and treatment of MS by addressing important unmet medical needs for people living with the disease. Between clinical trials and commercial use in more than 40 countries, approximately 30,000 patients have now been treated with Aubagio,” said David Meeker, CEO and President of Genzyme.

The exact mechanism of action of Aubagio is not clear, however, it is an agent with immunomodulatory  and anti-inflammatory properties. Nevertheless, its biological effect seems to involve a reduction in the number of activated lymphocytes in the central nervous system (CNS).

“With Lemtrada, we have also made significant progress with approvals in more than 30 countries. With our differentiated marketed therapies and a varied pipeline focusing on innovative treatment approaches and underserved MS patients with progressive disease, we are uniquely positioned to bring long-term value to the MS community,” added Meeker.

Lemtrada (Alemtuzumab) is approved in the European Union, Australia, Canada, Mexico, Brazil, Argentina, Chile and Guatemala, but not in the United States. The U.S. Food and Drug Administration (FDA) has agreed to review the resubmission of Lemtrada application for future US approval. Alemtuzumab is a monoclonal antibody that targets specifically CD52, a protein abundant on T and B cells, leading to the depletion of T and B cells in circulation, which are responsible for the inflammatory process that promotes MS development. Over time, after depletion, there is a repopulation of T and B cells with different functional properties, which rebalance the immune system in a way that potentially reduces MS severity.