Sanofi’s Lemtrada fails to win FDA approval

Sanofi failed to win US regulatory approval for its multiple sclerosis drug Lemtrada, denting the company's ambitions of capturing a larger share of the $20 billion market for the disease.

The US Food and Drug Administration said Sanofi's Genzyme unit didn't submit evidence from "adequate and well-controlled studies" showing that the benefits of Lemtrada outweigh its side effects, the Paris-based company said in a statement today.

Sanofi disagrees with the conclusion and said it will appeal.

Lemtrada, which was approved in the European Union in September, was a key part of Sanofi’s $20.1 billion acquisition of Genzyme in 2011.

The FDA indicated one or more additional trials comparing Lemtrada with another drug are needed for approval, Sanofi said. That would delay the product’s entry to a market dominated by Teva’s Copaxone, Biogen’s Tecfidera, Avonex and Tysabri, Novartis’s Gilenya and Merck’s Rebif.

“This was a big blow for Sanofi, as Lemtrada would have provided a significant growth engine for the company as early as 2014,” said Eric Le Berrigaud, an analyst at Bryan Garnier in Paris. “The key question now is whether they will commit to financing new trials in a scenario in which they would be delayed by three years in entering a very crowded market in 2018 to 2019. I’m not very optimistic about the appeal of the FDA decision.”

Sanofi fell 0.3 per cent to €76.28 in Paris. German partner Bayer, which has the right to co-promote Lemtrada in the US if it's approved and would receive payments based on sales, declined 1.1 per cent to €101.95 in Frankfurt.

The market for MS drugs will grow to $20.2 billion a year by 2017, according to a 2011 report by GlobalData, a London- based research company.

FDA staff determined in a November report that Lemtrada has “serious and potentially fatal safety issues” including risk of cancer and autoimmune and thyroid diseases. - (Bloomberg)