Biogene's Tecfidera becomes the third oral multiple sclerosis treatment on the market, rivaling Teva's injectable Copaxone.
The European Medicines Agency (EMA) today recommended the approval of Biogene Iden Inc (Nasdaq: BIIB) multiple sclerosis treatment Tecfidera for marketing in Europe. The approval of Biogene's oral treatment is likely to hit sales of Teva Pharmaceutical Industries Ltd. (NYSE: TEVA; TASE: TEVA) flagship branded drug Copaxone, which is an injectable treatment for multiple sclerosis. The US Food and Drug Administration (FDA) is expected to approve Tecfidera for marketing in the US on March 28.
Analysts believe that Biogene's drug, which was called BG-12 in the clinical trial stage, will take a 20% market share worth $3.25 billion annually.
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. Thus any harm to Copaxone's market standing raises investor concerns and pushes Teva's share price down.
Tecfidera is set to 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 24, 2013
© Copyright of Globes Publisher Itonut (1983) Ltd. 2013
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Gali Weinreb and Chen Ma'anit