Lemtrada Hits Primary Endpoint in Phase-3 MS Trial
[Showing superiority to one of the interferon drugs (Rebif in this instance) does not in itself herald commercial success. Regulatory approval is likely, but questions remain about where Lemtrada fits in the clinician’s armamentarium.]
LONDON - Sanofi’s experimental drug Lemtrada reduced relapses from multiple sclerosis and stopped the disease from worsening more than an older drug in a late-stage trial.
Patients given Lemtrada had a 49 percent reduction in relapses compared with Merck KGaA’s medicine Rebif, Paris-based Sanofi said yesterday. The drug may prove too toxic to be a blockbuster, said Vincent Meunier, an analyst at Exane BNP Paribas in Paris. The safety profile of the drug was “consistent’’ with previous use of Lemtrada and side effects continued to be “manageable,’’ the company said.
Chief executive Christopher Viehbacher has been building up the multiple sclerosis business since the $20.1 billion purchase of US biotechnology company Genzyme Corp., which was developing Lemtrada. Sanofi has been hunting outside the company for new sources of revenue as some of its best-sellers, such as the Lovenox blood-thinner and the Taxotere cancer drug, face generic competition.
“The results aren’t bad but there is nothing in them that prompts us to increase our sales estimates for this drug,’’ Meunier said in a phone interview. “We believe Lemtrada will be an efficacious medicine but with a toxic profile, meaning its sales potential is limited.’’
The risk of patients’ disability worsening dropped by 42 percent in the 840-patient study, dubbed CARE-MS II.
The most common adverse events associated with alemtuzumab, the chemical name for Lemtrada, were reactions linked to infusion of the drug, such as headaches, rashes, fever, nausea, itching, and fatigue, Sanofi said. Lemtrada users also developed infections, the company said.
Safety of Lemtrada “remains the concern given that this drug produces profound depletion of the immune system,’’ Mark Clark at Deutsche Bank AG wrote in a note yesterday. “We continue to believe its role will primarily be as rescue, or third-line, therapy.’’
Michael Panzara, Genzyme’s therapeutic area head in multiple sclerosis, immune diseases, and neurology, disagreed.
“Given the data we’ve seen today, there’s no suggestion that it would be relegated to that line of therapy,’’ Panzara said in a telephone interview yesterday. “We have a very comprehensive program showing that it’s quite efficacious and has safety events that are manageable, detectable, and treated.’’
As part of the deal struck in February with Genzyme, Sanofi set up a so-called contingent value right tied to Lemtrada’s future sales. The CVR was designed to protect the French drug maker against the potential failure of the treatment and reward Genzyme investors if it succeeds.
Stockholders got one CVR for each Genzyme share they owned. Investors stood to receive payments of as much as $14 per CVR if Lemtrada wins US approval and reaches sales goals, and if the company met production goals for existing Genzyme drugs. Sanofi said July 28 it missed the first production goal.‹
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