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Sanofi submits MS drug Lemtrada for approval in EU and US

Once-yearly treatment will challenge both Merck KGaA’s Rebif and Novartis' Gilenya if approved

Sanofi has submitted its multiple sclerosis (MS) treatment Lemtrada (alemtuzumab) for regulatory approval in both the US and EU.

The France-based pharma company, which gained rights to the drug after its $20.1bn acquisition of Genzyme, has filed applications to both the Food and Drug Administration (FDA) and European Medicines Agency (EMA) for the drug's use in the treatment of relapsing MS.

If approved, Bayer Healthcare, which co-developed the drug with Genzyme, will retain an option to co-promote Lemtrada, although Sanofi would have primary responsibility for its development and commercialisation.

The drug is expected to do well if it makes it to market, with its yearly dosing regimen giving it an advantage over treatments that have to be taken more often, such as Merck KGaA's Rebif (interferon beta-1a).

The drug has also demonstrated superior efficacy to Rebif in clinical trials, achieving a 49 per cent reduction in relapse rates compared to Rebif in the CARE-MS II trial.

In addition, Lemtrada 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's main competition is expected to come from Novartis' oral MS drug Gilenya (fingolimod), however, with the drug having been available in the US since 2010.

This is despite a recent update to the label of Novartis' drug to remove its approval for use in patients with a history of heart disease or stroke, after completing a review of the drug's safety. It is also contraindicated in patients taking anti-arrhythmic drugs.

Despite such competition, Dr David Meeker, president and CEO of Genzyme, was still confident of the Lemtrada's success: “There remains a large unmet treatment need for patients living with active disease and we believe that Lemtrada, given its efficacy and unique dosing schedule, has the potential to transform the lives of patients with multiple sclerosis.”

The success of the drug is key for Sanofi in its attempt to deal with several major patent losses that are set to hit revenues hard in 2012.

In its financial results for 2011, the company said it expects €1.4bn to be knocked off its net income for 2012 due to generic competition for its blood thinner Plavix and hypertension treatment Avapro.

13th June 2012

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