Relapse rates and sustained accumulation of disability remained low among patients who had been administered the treatment in previous clinical trials, Paris-based Sanofi said in an e-mailed statement today. More than 80 percent of patients did not receive a further course of Lemtrada during the first year of the extension study, the company said.
Lemtrada, also known as alemtuzumab, is a so-called monoclonal antibody administered to patients through infusions in two cycles at a 12-month interval. Sanofi obtained the medicine through its $20.1 billion purchase of U.S. biotechnology company Genzyme Corp. in 2011. Sanofi last year introduced its first MS therapy, the pill Aubagio, in a bid to build up its MS business.
“It’s another confirmation of the benefit a product like this can bring,” Bill Sibold, Genzyme’s head of MS, said in a telephone interview from San Diego, California. The latest data is evidence of Lemtrada’s “durable effect,” he added.
In more than 70 percent of patients, disability scores improved or remained stable, according to Sanofi.
The interim data, presented today at the annual meeting of the American Academy of Neurology in San Diego, “really speaks to Lemtrada’s unique approach to disease modification, where you have this rebalancing of the immune system after these two courses of treatment,” Michael Panzara, Genzyme’s therapeutic area head for MS and neurology, said during the same interview.
The U.S. Food and Drug Administration accepted Sanofi’s application for approval of Lemtrada, five months after rejecting an initial filing because of the way data was formatted, Sanofi said Jan. 28. It expects a decision by U.S. regulators in the second half of the year.
Late-stage clinical trials published previously showed Lemtrada slowed the progression of disability, although it led to infections and an autoimmune thyroid-related side effect in some patients. Side effects during the one-year extension period were “very consistent” with what already has been reported, Panzara said.
“We’re not seeing any new signals,” he said. “In fact, we would anticipate that since so few patients actually require additional courses of therapy that the overall profile will continue to improve.”
Sanofi needs new drugs such as Aubagio to help offset revenue losses from generic competition to best-sellers including the blood thinner Plavix. The French company still plans to beef up its MS pipeline through partnerships and acquisitions, Panzara and Sibold said.
Multiple sclerosis is caused by an abnormal immune response that attacks the protective covering that surrounds nerve cells in the brain and spinal cord. The assault stops nerve cells from sending signals, sapping patients’ energy, blurring their vision and slowly robbing them of mobility, balance and coordination.
The market for MS drugs will grow to $19.6 billion annually by 2022 from $13.8 billion at present, Ravi Mehrotra and other Credit Suisse analysts forecast in an Oct. 8 note.
Aubagio and Lemtrada will have to make inroads in a market flooded by new products, such as Novartis AG’s pill Gilenya and Biogen Idec Inc. (BIIB)’s BG-12, which is awaiting a decision from U.S. regulators this month.
“What happens or doesn’t happen with BG-12 really isn’t relevant to what we are seeing here,” Panzara said. Lemtrada “approaches the disease in such a different way” that it’s “in a different category.”
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