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Biogen Idec advances blockbuster MS franchise on two key fronts

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Biogen Idec ($BIIB) has taken a couple of big steps forward in building up its blockbuster franchise for multiple sclerosis drugs. Fresh from wrapping up a deal to take control of all of the rights to Tysabri, the biotech won 15-year patent protection for its closely watched Phase III MS drug Tecfidera (better known as BG-12 on the R&D side of the business). And simultaneously, investigators reported positive results from a late-stage study of one of its other late-stage MS drugs, Plegridy, or peginterferon beta-1a.

Tysabri is a market leader in the big MS market, but it is also linked with a lethal side effect. Biogen Idec is expected to land an FDA approval soon for Tecfidera, widely viewed as the best in a new bunch of treatments. If it does, it will have patent protection on the 480-milligram daily dose for dimethyl fumarate, the active agent, until 2028.

Looking past that launch, Biogen Idec is preparing the groundwork for another application. 

Halfway through their two-year Phase III, the injectable Plegridy reduced the annual relapse rate of patients by 36% compared to a placebo, according to researchers. And while a single injection every four weeks met the goal in the study, patients getting an injection every two weeks performed better. The treatment also "reduced the number of new or newly enlarging T2-hyperintense lesions on brain MRI scans by 67 percent compared to placebo … and also demonstrated significant positive effects on disability progression by reducing the risk of 12-week confirmed disability progression ... by 38 percent compared to placebo."

"These full first-year results provide a more complete picture of Plegridy and its positive effects on the reduction of relapse, disability progression and lesion development," said Peter Calabresi, the director of the Johns Hopkins Multiple Sclerosis Center, in a release. "These data suggest that, if approved, Plegridy may offer the benefit of a less frequent dosing schedule, which would be a meaningful advance for people living with MS."

- here's the press release on Plegridy
- read the Reuters story on the Phase III
- see the Boston Globe report on the patent decision

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