Sanofi submits key MS pill for approval
pharmafile | June 12, 2012 | News story | Research and Development, Sales and Marketing | Bayer, EMA, FDA, Genzyme, Lemtrada, MS, Sanofi
Sanofi has submitted its multiple sclerosis pill Lemtrada for regulatory reviews in the US and Europe.
Lemtrada (alemtuzumab), originally developed by Genzyme and partner Bayer, has now been submitted for the treatment of relapsing multiple sclerosis (RMS).
The drug is key to Sanofi, and it based its $20 billion purchase of Genzyme on the drug’s potential.
Genzyme developed the drug with Bayer and the German firm will retain its option to co-promote the drug in MS and, upon regulatory approval and commercialisation, will receive payments based on sales revenue.
Genzyme has predicted that peak sales of Lemtrada – already licensed to treat leukemia under the name Campath – could earn as much as $2.5 billion a year.
Sanofi has been less optimistic and has forecast a more modest $700 million given the nature of the evolving MS market.
Genzyme president and chief executive David Meeker, said: “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 MS.”
Last year Phase III data showed that Lemtrada beat the standard injectable treatment Rebif (interferon beta-1a), made by Merck Serono, a significant boost for the drug.
But its main competition will come from Novartis’ MS pill Gilenya (fingolimod), which was the first oral treatment for the disease to reach the market.
The FDA and EMA recently limited use of Gilenya in some patients due to safety concerns over its affect on the heart, but the drug is still on track to make blockbuster sales.
In addition to Lemtrada, Genzyme has also submitted its once-daily oral treatment Aubagio (teriflunomide) for review by the FDA and EMA.
Ben Adam
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