Once-monthly MS drug from Biogen Idec, AbbVie clears Phase III hurdle

Biogen Idec and AbbVie announced Monday morning that their once-monthly multiple sclerosis drug daclizumab has cleared key hurdles in a Phase III study, setting the stage for a marketing pitch to regulatory authorities. For Biogen Idec ($BIIB), the Phase III success offers a chance to expand on its blockbuster MS franchise with an imperfect but potentially lucrative new drug with some troubling side effects. And AbbVie ($ABBV) has already counted this therapy as one of its top late-stage prospects.

On Monday morning, investigators announced that the injectable daclizumab (DAC HYP) generated a 45% drop in the annualized relapse rate of patients taking the drug compared to Biogen's once-weekly Avonex (interferon beta-1a). That's lower than the 54% recorded in the Phase IIb, but still good enough to meet the standard for statistical significance. And the drug also cleared the bar on one of two secondary endpoints.

Daclizumab--a CD25 blocker--was successful in reducing the number of new or newly enlarging T2-hyperintense lesions at week 96, with a 54% reduction relative to Avonex. But it failed at reducing the risk of three-month confirmed disability progression.

Biogen Idec--which locked up an approval for the hemophilia A drug Eloctate just days ago--has been making some big strides in the MS market recently, gaining an approval for the blockbuster drug Tecfidera and locking up the market rights to Tysabri. This new drug, which analysts have projected could earn up to $500 million a year, is likely to be pitched as an alternative, easier-to-use therapy with its once-monthly regimen. But oral drugs, some with better efficacy rates, have been making big inroads in the market. And analysts have also fretted in the past about the drug's safety profile.

Biogen reported that in patients treated with DAC HYP compared to IFN β-1a, "There was an increased incidence of serious infections (4% vs. 2%), serious cutaneous reactions (2% vs. < 1%), and elevations of liver transaminases greater than 5 times the upper limit of normal (6% vs. 3%). There were four deaths in the IFN β-1a group and one death in the DAC HYP group, none of which was considered treatment related."

Investigators recruited more than 1,800 patients for the study.

AbbVie gained rights to the drug back in 2010 when it bought out Facet for $700 million, which was partnered at the time with Biogen Idec. AbbVie execs have identified this program as one of its top late-stage prospects, all of which are badly needed to prep that company for a future without Humira.

"The results of the DECIDE study are compelling, with DAC HYP demonstrating robust efficacy compared to a current standard of MS care," said Gilmore O'Neill, vice president of Global Neurology Clinical Development at Biogen Idec, in a statement. "As a potential once-monthly therapy with a novel mechanism of action, we believe that, if approved, DAC HYP will be an important treatment option for people living with MS."

- here's the release