Sanofi’s Lemtrada beats Rebif in MS study
pharmafile | October 25, 2011 | News story | Research and Development, Sales and Marketing | Lemtrada, Sanofi
Sanofi’s investigational multiple sclerosis drug Lemtrada has beaten Rebif in a late-stage trial.
The Phase III results show that 78% of patients treated with Sanofi’s Lemtrada (alemtuzumab) were relapse-free for two years when compared to just 59% for Merck Serono’s Rebif (interferon beta-1a).
As previously reporter Lemtrada managed a 55% reduction in relapse rate compared to Rebif over two years of study – this now satisfies the co-primary endpoint, which officially declares the study a success.
The drug, which is being developed by Sanofi in conjunction with Bayer, also met its secondary endpoints by creating a better Multiple Sclerosis Functional Composite score, a measurement of physical and cognitive function in MS patients compared to Rebif.
The drug is already licensed to treat certain blood cancers under the brand name Campath, and was originally developed by US biotech Genzyme.
The results from the CARE-MS I trial will be big news for Sanofi, which based its $20 billion purchase of Genzyme on the drug’s potential.
Peak annual sales projections currently range between $700 million and $2.5 billion for Lemtrada, but it will have stiff competition from Novartis’ recently approved MS pill Gilenya.
If the drug is to take a slice of the MS market away from Gilenya – which comes in a more convenient pill form and is expected to generate around $3 billion in peak yearly sales – it will need to carry out successful head-to-head trials against the drug in the future.
It may also have to compete with Biogen’s MS pill BG-12 that significantly reduced the proportion of patients who relapsed by 50% at two years when compared to placebo in a recent Phase III trial.
Results from the second phase III trial, CARE-MS II, which is looking at Lemtrada in combination with another MS drug, is expected later this year.
Professor Alastair Compston, head of the Department of Clinical Neurosciences at the University of Cambridge and lead investigator said: “CARE-MS I confirms that, in a head-to-head comparison with Rebif, disease activity is significantly reduced in patients with early relapsing-remitting multiple sclerosis treated with Lemtrada, over the first two years of observation.
“These data support the robust efficacy profile and potential that Lemtrada offers for patients with relapsing-remitting multiple sclerosis requiring a more effective option than currently available therapies,” he added.
Ben Adams
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