Genzyme's pivotal studies on LEMTRADATM (alemtuzumab) published in The Lancet
Nov 01, 2012 (Menafn - M2 EQUITYBITES via COMTEX) --Genzyme, a Sanofi company SNY and a developer and provider of transformative therapies, announced today the publication of results from the LEMTRADA (alemtuzumab) CARE-MS I and CARE-MS II pivotal studies in patients with relapsing-remitting multiple sclerosis (MS) in the 1 November 2012 online issue of The Lancet.
The company said that in CARE-MS I and CARE-MS II, LEMTRADA was significantly more effective at reducing annualised relapse rates than the active comparator Rebif (high dose subcutaneous interferon beta-1a) and more patients on LEMTRADA were relapse-free at two years.
Also, in CARE-MS II, accumulation of disability was significantly slowed in patients given LEMTRADA, as compared with Rebif.
In addition, patients treated with LEMTRADA were significantly more likely to experience improvement in disability scores than those treated with Rebif, suggesting a reversal of disability in some patients.
CARE-MS I and CARE-MS II (Comparison of Alemtuzumab and Rebif Efficacy in Multiple Sclerosis) are randomised Phase III studies comparing the investigational treatment alemtuzumab to a standard of care MS treatment, Rebif, in patients with relapsing-remitting MS who were naive to prior treatment or who had relapsed while on prior therapy, respectively.
The results from these trials for LEMTRADA were reportedly superior to Rebif on clinical and imaging endpoints, including a reduction in relapse rate and are published in full in The Lancet.
Genzyme holds the worldwide rights to LEMTRADA and has primary responsibility for its development and commercialisation in multiple sclerosis. Bayer HealthCare retains an option to co-promote LEMTRADA in multiple sclerosis.
Also, Bayer HealthCare has notified Genzyme of its intention to co-promote under this option. Upon regulatory approval and commercialisation, Bayer would receive contingent payments based on sales revenue, the company said.
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