The Burrill Report


The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended approval of two new oral therapies for multiple sclerosis, Sanofi’s Aubagio and Biogen Idec’s Tecfidera, offerings that will create significant new competition for current injectable multiple sclerosis drugs.

“With the CHMP’s positive opinion for Tecfidera we are one step closer to offering the European MS community a treatment with compelling efficacy and a favorable safety profile in the convenience of a pill—a combination we believe will have a significant positive impact on the way people live with this chronic disease,” says George Scangos, Biogen’s CEO.

The CHMP's recommendations will now be referred to the European Commission, which grants marketing authorization for medicines in the European Union.

If approved, the pills would offer a new option for the 630,000 people affected by multiple sclerosis in Europe, posing new competition for the first pill for MS, Novartis’ Gilenya, and injectable therapies, including Biogen’s own MS drugs, Avonex and Tysabri.

The U.S. Food and Drug Administration approved Aubagio, a once-daily, oral treatment for patients with relapsing forms of multiple sclerosis in September 2012. Biogen is still awaiting an FDA decision on Tecfidera. That is expected by the end of March.

“This positive CHMP opinion and broad recommended indication reflect the strong data from Aubagio's clinical development program,” says Genzyme CEO and President David Meeker. “As we've seen from the uptake of Aubagio in the United States, many patients are looking for an alternative to current injectable therapies.”

Tecfidera is expected to generate $3.25 billion by 2017, according to a Bloomberg average of analyst estimates, while Aubagio sales are estimated to generate $389 million (€300 million) annually by 2016.





March 22, 2013
http://www.burrillreport.com/article-sanofi_and_biogen_get_eu_nod_on_ms_drugs.html