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Sanofi's Lemtrada outperforms Merck Serono's Rebif in a head-to-head trial

Phase III trial results could see Sanofi file for US and European approvals in the first quarter of 2012

Sanofi's multiple sclerosis treatment Lemtrada has beaten Rebif in a head-to-head trial that could see the French pharma company file for US and European approval in the first quarter of 2012.

The CARE-MS II trial showed Lemtrada (alemtuzumab) outperforming Merck Serono's Rebif (interferon beta-1a) and meeting both of the study's primary endpoints.

The two-year trial involved 840 patients receiving a 12mg dose of Lemtrada and showed Sanofi's drug achieved a 49 per cent reduction in the relapse rates compared to Rebif.

Lemtrada also met the second of its co-primary end points, cutting the risk of sustained worsening of disability by 42 per cent compared to Rebif.

Sanofi and its partner Bayer said the results were 'highly statistically significant'.

Professor Alastair Compston, chair of the Steering Committee overseeing the conduct of the study said: "Taken together, the phase II and III clinical trial data illustrate the promise that alemtuzumab holds as a transformative treatment for people with relapsing MS."

The results will also help prove the case for Sanofi's acquisition of Genzyme, which originally developed the drug. Sanofi completed the deal with the US biotech in April for around $20.1bn and the financial value of the deal is partly linked to the success of Lemtrada.

David Meeker, Genzyme's CEO, said the CARE-MS study was “unprecedented”, showing the drug had “impressive efficacy, novel dosing regimen and manageable safety profile”.

“Based on these positive results, we are on track to submit Lemtrada for review to US and EU regulatory authorities in the first quarter of 2012.”

15th November 2011

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