Sanofi presents parallel apps for blockbuster MS hopeful Lemtrada

Sanofi is on track to find out whether its $20 billion deal for Genzyme will pay off with a near-term drug approval. The pharma giant ($SNY) says that Genzyme has submitted applications for the MS drug Lemtrada in both the U.S. and Europe. Bayer is partnered on the program.

Sanofi and Genzyme are banking on data from a pair of late-stage studies which demonstrated superiority over Rebif on some key points in a head-to-head matchup, including a reduction in relapse rates. Rebif is also administered several times a week while Lemtrada is provided in two treatment courses, one course every 12 months over two years, helping Sanofi/Genzyme gain good odds for an approval. 

The twin regulatory filings create a parallel regulatory track for Sanofi's Aubagio, another MS drug that was already in Sanofi's pipeline when it bought Genzyme. "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," said Genzyme CEO David Meeker.

At the time Sanofi was working on its buyout deal for Genzyme, CEO Chris Viehbacher had largely downplayed Lemtrada's potential on the market. After the deal went through, though, Viehbacher and the rest of the Sanofi team took a considerably more enthusiastic view of the MS program. "I think Lemtrada is going to be completely different than everything else, which makes it difficult for the market to assess," Sanofi Chief Executive Chris Viehbacher told Reuters recently.

Analysts, though, have largely kept their enthusiasm in check. Morgan Stanley has estimated peak sales at $1.25 billion, according to the news service, while Normura has stuck with a more tepid $360 million. 

- here's the press release
- read the Reuters story

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