Tecfidera means the product sold as of the Agreement Date by Licensee under Licensee's tradename and marketing authorization for its oral formulation of dimethyl fumarate indicated for the treatment of multiple sclerosis at the recommended dose of 480 mg/day associated with NDA No. 204063 and equivalent approvals in Designated Countries.
Labeled Indications for MS Treatments 17 NYSE MKT: SYN All products are approved only for the relapsing - remitting type of MS Brand Name Relapsing - Remitting MS Relapsing - Remitting MS Decrease exacerbation frequency Slow disability accumulation First clinical episode Avonex x x x Rebif x x Betaseron x x Extavia x x Copaxone x x Gilenya x x Tecfidera x Tysabri * x x Aubagio x * Tysabri recommended for patients who have had an inadequate response to, or are unable to tolerate, an alternate MS therapy.
Biogen shares fell 20% as sales for its key multiple sclerosis drug, Tecfidera, failed to meet expectations.
The only thing that has occurred since Elan's Tysabri sale to Biogen is the very successful launch of Biogen's competitive drug Tecfidera.