The US Food and Drug Administration (FDA) has approved Tecfidera, an oral multiple sclerosis treatment for marketing. The drug has been developed by Biogene Iden Inc. (Nasdaq: BIIB) and was known as BG-12 in its clinical trials. The drug will compete with Teva Pharmaceutical Industries Ltd. (NYSE: TEVA; TASE: TEVA) multiple sclerosis treatment Copaxone. Tecfidera is considered more effective and is taken orally while Copaxone is injected.
Wall Street analysts believe that Tecfidera will become the number one oral treatment for multiple sclerosis with annual sales of more than $3 billion. No severe side effects have been found from the drug so far.
In 2012, Copaxone had annual sales of $4 billion, 19.7% of Teva's overall revenue, and was reportedly responsible for 40-60% of the pharmaceutical company's profit. Biogene said that marketing of Tecfidera will begin within days.
Last week the European Medicines Agency (EMA) recommended the approval of Tecfidera for marketing in Europe though it is likely to take some months before the drug is on sale in Europe.
Tecfidera will become the third oral multiple sclerosis treatment on the market after Novartis's Gilenya and Sanofi's Aubagio.
Published by Globes [online], Israel business news - www.globes-online.com - on March 28, 2013
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