Drug evaluation: BG-12, an immunomodulatory dimethylfumarate.

Biogen Idec Inc, following its acquisition of Fumapharm AG, is developing BG-12 (Panaclar, BG-00012, FAG-201), an oral second-generation fumarate derivative, for the potential treatment of multiple sclerosis (MS). In January 2007, a phase III program for relapsing-remitting MS patients was initiated. The company was also developing the drug for psoriasis and, in October 2003, Biogen Idec expected to commence phase III trials for psoriasis in the US in the following year. In April 2005, the drug met its European phase III psoriasis trial endpoint, with the data expected to be used to support a market authorization filing in Germany in 2005. It was later disclosed that while an application had been filed, this was subsequently withdrawn based on a joint decision by Fumapharm and Biogen Idec. No further development has been reported on BG-12 for psoriasis in the US and it was not listed as a pursued indication on Biogen Idec's April 2007 pipeline.