Genzyme, a Sanofi company, will be presenting a new data from Genzyme’s clinical development programmes for Aubagio (teriflunomide) and Lemtrada (alemtuzumab) from October 10-13, 2012 at the 28th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Lyon, France.
“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 US 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.
The US Food and Drug Administration (FDA) has approved Aubagio (teriflunomide) as a once-daily, oral immunomodulator indicated for patients with relapsing forms of multiple sclerosis (MS). The ongoing Aubagio clinical development programme, involving more than 5,000 patients in 36 countries, is among the largest of any MS therapy. Some patients in extension trials have been treated up to 10 years.
Aubagio is an immunomodulator with anti-inflammatory properties. Although the exact mechanism of action for Aubagio is not fully understood, it may involve a reduction in the number of activated lymphocytes in the central nervous system (CNS).
Alemtuzumab is a monoclonal antibody that selectively targets CD52, a protein abundant on T and B cells. Treatment with alemtuzumab results in the depletion of circulating T and B cells thought to be responsible for the damaging inflammatory process in MS. Alemtuzumab has minimal impact on other immune cells. The acute anti-inflammatory effect of alemtuzumab is immediately followed by the onset of a distinctive pattern of T and B cell repopulation that continues over time, rebalancing the immune system in a way that potentially reduces MS disease activity.
Genzyme has the worldwide rights to alemtuzumab and has primary responsibility for its development and commercialization in MS. Bayer HealthCare has been co-developing alemtuzumab in MS with Genzyme. Bayer HealthCare retains an option to co-promote alemtuzumab in MS and, upon regulatory approval and commercialization, would receive contingent payments based on sales revenue.
Lemtrada is the proprietary name submitted to health authorities for the company’s investigational multiple sclerosis agent alemtuzumab.
Genzyme has pioneered the development and delivery of transformative therapies for patients affected by rare and debilitating diseases. The company focussed on rare diseases and multiple sclerosis, we are dedicated to making a positive impact on the lives of the patients and families we serve.
Sanofi, a global and diversified healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients’ needs. Sanofi has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and the new Genzyme.