The U.K.’s health-cost regulator asked Sanofi for more information on its multiple-sclerosis drug Lemtrada, less than a month after U.S. regulatory advisers said the drug’s trials weren’t adequate to assess its efficacy.
The National Institute for Health and Care Excellence is seeking clarifications on the evidence Paris-based Sanofi’s Genzyme unit submitted on the drug, NICE said in draft guidance today. Sanofi has until Jan. 9 to submit the extra information, the institute said. NICE, which advises the U.K.’s National Health Service on which treatments provide value for money, didn’t specify what information it requested.
Lemtrada, approved in the European Union in September, was a key part of Sanofi’s $20 billion acquisition of Genzyme in 2011. The U.S. Food and Drug Administration is expected to decide by the end of this year whether to approve the drug, which will compete in an increasingly crowded market against treatments such as Novartis AG’s Gilenya and Teva Pharmaceutical Industries Ltd.’s Copaxone.
Lemtrada may generate sales of 455 million euros ($619 million) in 2017, according to the average of eight analysts’ estimates compiled by Bloomberg. Bayer AG plans to co-promote the drug in the U.S. and will receive payments based on sales. Sanofi said in October it would charge 8,645 euros per vial for the drug in Germany.
Sanofi fell 0.3 percent to 74.71 euros as of 11:39 a.m. in Paris. The stock has gained 8 percent this year, including reinvested dividends, compared with a 25 percent advance in the Bloomberg Europe Pharmaceuticals Index.
The drug is a so-called monoclonal antibody administered to patients through two sets of infusions a year apart. Late-stage clinical trials showed the treatment slowed the progression of disability, though it also led to infections and an autoimmune thyroid-related side effect in some patients.
Sanofi’s first MS therapy, a tablet called Aubagio, won approval in the U.S. last year and in the EU this year. The drugmaker is counting on new products to offset revenue losses from generic competition to best-sellers including the blood-thinner Plavix.
Multiple sclerosis is a debilitating disease that attacks the central nervous system. Relapses, or flare-ups, are episodes of worsening neurological function. More than 100,000 people in the U.K. have the disease, according to the Multiple Sclerosis Trust.
An FDA advisory committee voted last month that Lemtrada is effective for preventing flare-ups of the disease, even as it decided the company’s trials weren’t adequate to assess the drug.