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Biogen bolsters MS franchise with U.S. approval of longer half-life Plegridy

By Randy Osborne, Staff Writer

Biogen Idec Inc. disclosed after the market closed Friday that its multiple sclerosis (MS) therapy Plegridy (peginterferon beta-1a) won FDA clearance for relapsing forms of the disease. The only pegylated interferon cleared for relapsing MS, Plegridy is dosed every two weeks subcutaneously by way of an auto-injector pen or prefilled syringe – a substantial improvement over the half-life of Cambridge, Mass.-based Biogen’s Avonex (interferon beta-1a), which must be given weekly.

The clearance of Plegridy by U.S. regulators came as little surprise and follows the July approval in the European Union, and shares of Biogen (NASDAQ:BIIB) did not change much as a result. They were trading in the morning at $346.84, up $4.21.

Biogen also sells Tecfidera (dimethyl fumarate) for relapsing MS, an oral therapy that has been steadily gaining market share. Tecfidera won approval in March 2013 by the FDA, and in February the following year in the European Union.

Plegridy, though, should help Biogen hold its ground in MS injectables, and the U.S. label for the compound is similar to the label in Europe, though the European Public Assessment Report tacked on precautionary language about use of the drug in patients with thyroid problems.

As MS patients shift from injected to oral therapies, pricing will be important. The wholesale acquisition cost of Avonex is $59,085, and Wells Fargo analyst Brian Abrahams models per patient net revenues of $50,672 for 2014, increasing to $54,219 in 2015.

“We anticipate Plegridy will be priced similarly to Avonex,” Abrahams wrote in a research report today, estimating 2014 U.S. penetration in first, second, and third-line treatment for relapsing MS at 21 percent, 11 percent, and 7 percent, respectively, and shifting to 20 percent, 10 percent, and 7 percent in 2015. “Increasing use of all-oral therapies will be offset by potential share gains over Rebif [beta interferon 1a, Merck Serono SA] and Copaxone [glatiramer acetate injection, Teva Pharmaceutical Industries Ltd.], as well as better retention thanks to the favorable administration profile,” in his view.

The FDA gave Plegridy the nod based on data from a study known as Advance that involved more than 1,500 patients in a two-year, phase III, placebo-controlled (in year one) experiment.

See the next edition of BioWorld Today for more on this story.