Sanofi has rolled out a fresh set of late-stage Lemtrada (alemtuzumab) data demonstrating its superiority to Rebif in a head-to-head matchup for multiple sclerosis. One of the key programs acquired in Sanofi's ($SNY) $20 billion Genzyme buyout, Lemtrada is increasingly looking like an odds-on winner at the FDA. And the pharma giant's success with the drug--alongside its other Phase III MS program--has inspired the pharma giant to spread its global BD net in search of other treatments.
Patients taking Lemtrada in the study scored better at slowing disease progression, with a sizable minority doing better as a larger proportion of Rebif patients faltered. Altogether 29% of the Lemtrada patients scored better on disability, compared to 13% for the Rebif group. Close to two thirds of the patients were relapse-free at 2 years, compared to 47% in the Rebif arm.
"To date, a key goal for MS treatment has been to delay the worsening of disability," said Jeffrey Cohen, M.D., an MS investigator. "Patients in the study whose prior MS treatment was inadequate at preventing relapses and received alemtuzumab in the CARE-MS ll trial experienced a slowing or reversal of their disability."
For Genzyme MS chief Michael Panzara, the bottom line is simple: "Alemtuzumab versus Rebif improves function; that's unique," he told Bloomberg.
Not everyone is happy about the drug's tox profile, though. Investigators have already noted that 16% of the patients taking the drug developed an autoimmune related adverse event, compared to 5% for Rebif patients.
But that AE profile hasn't reduced Sanofi's public confidence. Panzara went on to tell Bloomberg that Sanofi is always looking for more MS drugs to add to the pipeline, which includes Aubagio. "You can't have a world-class MS organization if you don't fill up the pipeline at all stages of development."
- here's the press release
- get the Bloomberg report on the data
- read the Bloomberg report on the deal side