A Jab a Month Is All We Ask

Would you rather inject yourself once a month or take a pill every day? Unless you're extremely needle-phobic, it's not an easy question to answer. There are advantages and disadvantages to both.

Biogen Idec (NAS: BIIB) is hedging its bets, figuring there will be a market for both types of multiple sclerosis treatments. It's already produced positive phase 3 data for its oral BG-12 and yesterday released solid -- albeit far from perfect -- phase 2b data for its once-monthly daclizumab.

The drug's efficacy looks pretty good. Patients taking once-monthly daclizumab had an annualized relapse rate 50% to 54% depending on the dose compared with patients taking a placebo. That's on par with BG-12 and certainly better than Teva Pharmaceuticals' (NAS: TEVA) laquinimod and its adjusted 21% reduction in the annualized relapse rate.

But the side-effect profile leaves something to be desired. Serious infections occurred in 2% of patients taking once-monthly daclizumab compared with 0% in placebo. That's not all that surprising, since the drug is designed to inhibit the immune system; Roche sells a version of daclizumab called Zenapax to treat organ-transplant patients.

The bigger worry might come from the 4% of patients whose liver enzyme levels were five times higher than normal, which is a good indicator that the drug might be damaging the liver. And since it's a monthly treatment, the drug will be in the system for quite awhile after doctors decide there's a problem.

Two patients taking once-monthly daclizumab died while in the study, although it wasn't clear the drug was the cause.

The mixed data is good enough for Biogen and its partner Abbott Labs (NYS: ABT) to continue with the currently enrolling phase 3 trial, but not so great that investors should pencil in revenue from once-monthly daclizumab. The drug would certainly be more convenient than current multiple sclerosis treatments like Copaxone from Teva and Rebif from Pfizer (NYS: PFE) and Merck KGaA, but we'll have to see data from a larger and longer trial to know whether the risk-reward profile is good enough to get past the Food and Drug Administration.

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At the time this article was published Fool contributor Brian Orelli holds no position in any company mentioned. Check out his holdings and a short bio. The Motley Fool owns shares of Teva and Abbott. Motley Fool newsletter services have recommended buying shares of Teva, Pfizer, and Abbott. Try any of our Foolish newsletter services free for 30 days. We Fools don't all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy.

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