Multiple Sclerosis: The Advent of the Orals - Pharmaceutical Executive

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Multiple Sclerosis: The Advent of the Orals


Pharmaceutical Executive



The $8 billion dollar multiple sclerosis (MS) market is set to double the number of available treatments in the near future, with a dramatic switch from injectables to oral medications. On the heels of Novartis' first-to-market Gilenya, whose uptake has exceeded all expectations, Merck KGaA, Teva, Sanofi-Aventis, and Biogen Idec all have MS pills prepping for a date with the FDA. Developed by MS powerhouse Biogen, BG-12 (dimethyl fumarate) triggers the Nrf2 pathway, defending against oxidative stress that can cause inflammation and injury to neurons and the CNS myelin, which, in turn, trigger MS symptoms. Phase IIb data also showed that B-12 cut the number of brain lesions in patients with relapsing-remitting MS by 69 percent compared to placebo.



Two Phase II injectable monoclonal antibodies also evince disease-modifying promise. Roche's ocrelizumab, a monoclonal antibody related to rituximab for rheumatoid arthritis (RA), depletes B cells, which play a role in the autoimmune destruction caused by MS. In a Phase II study, the high dose of ocrelizumab reduced the number of brain lesions by 96 percent compared to placebo, the low dose by 89 percent. The relapse rates fell by 80 percent and 73 percent, respectively.



Genzyme's alemtuzumab, already sold as Campath for chronic lymphocytic leukemia, shows exceptional efficacy, reducing the relapse rate of patients in a Phase II study by 87 percent after five years, compared to the standard of care. The monoclonal antibody targets the CD52 protein on the surface of certain T cells, B cells, and other lymphocytes, which MS mistakenly turns against neurons and myelin. Over the ensuing several years, these immune cells grow back—theoretically free of the MS stamp. Should alemtuzumab win approval, Genzyme (or Sanofi-Aventis, if its hostile takeover succeeds) will face the ethical and PR quandary of pricing a new drug for MS that is already available as a cancer drug, the quandary being that MS patients need only eight infusions over four years, about $10,000 at Campath's rate. Rival MS treatments cost $30,000 or more.

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