Sanofi ($SNY)and Genzyme ($GENZ) never could agree on peak sales estimates on Lemtrada, the Boston biotech's late-stage oral therapy for MS, when the two negotiated over buyout terms. Over the weekend, however, the spotlight of the investigative team was squarely on the positive side as new late-stage data underscored the treatment's superiority over an aging standard. After two years 78% of patients taking Lemtrada remained relapse-free, a mark hit by a relatively low 59% of the patients in the arm receiving the injectable Rebif.
Genzyme investigators of course ultimately had to settle for special CVR certificates to cover Lemtrada, known chemically as alemtuzumab. Now a new round of Phase III data is due before the end of the year, which is expected to help seal Sanofi's case for an NDA.
"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 alemtuzumab, over the first two years of observation," said Professor Alastair Compston, head of the Department of Clinical Neurosciences at the University of Cambridge and overseer of the study. "These data support the robust efficacy profile and potential that alemtuzumab offers for patients with relapsing-remitting multiple sclerosis requiring a more effective option than currently available therapies."
If approved, Lemtrada would face significantly steeper competition than Rebif. Not only was Novartis's oral drug Gilenya approved earlier this year, Biogen Idec has a closely watched late-stage program under way for BG-12. Biogen unveiled its own upbeat assessment of new late-stage efficacy and safety data just last week. And Teva ($TEVA) has a horse in this race as well.
- read the press release
- here's the Reuters report