Billing it as the most important new innovation in the interferon drug class in a decade, Biogen Idec nailed down the FDA's approval of Plegridy, a new multiple sclerosis drug that patients can easily inject themselves with once every two weeks.
Essentially, Plegridy (peginterferon beta-1a) is a new-and-improved version of Avonex, Biogen's once weekly interferon beta therapy for relapsing forms of MS. Researchers added a polymer to the mix that allowed for the easier dosing schedule and Biogen gained a new therapy for its impressive portfolio of MS therapies. A little more than a year ago, Biogen gained an approval for Tecfidera, which is helping establish a new standard of care for many patients with relapsing MS. It also sells Tysabri.
The drug OK marks another improvement in Biogen's competitive position with two other key players on the market. Plegridy--also approved in Europe--should eat into Avonex's market share while also elbowing into the markets for Copaxone from Teva ($TEVA) and Merck KGaA's Rebif. EvaluatePharma pegged 2020 sales at a bit more than $1 billion, marking this as one of the top blockbusters in the industry's late-stage pipeline.
"We forecast Plegridy revenue of $1bn by 2027," Bernstein's Geoffrey Porges forecast in a note today, "but flat sales for the combined Avonex/Plegridy franchise."
Biogen's fresh advance on the MS front came as no great surprise to investors. The company's shares ($BIIB) surged a bit under 1% in after-market trading Friday as news of the approval spread.
The company devised an autoinjector device called the Plegridy Pen to inject the treatment, using a prefilled syringe.
In the 1,500-patient "Advance" study, Biogen showed that peginterferon beta-1a reduced annualized relapse rates at one year by 35.6% in patients getting injections every two weeks and by 27.5% in those on four-week dosing compared with placebo. And coming up behind this drug is a key catalyst for another MS drug that may help spur remyelination, actually repairing some of the damage done by the disease.
"Plegridy offers people with MS robust efficacy, a safety profile consistent with the established interferon class, and significantly fewer injections than other beta interferon treatments," said Biogen CEO George Scangos in a statement. "Plegridy represents the most significant innovation in the interferon class in over a decade, and is the result of our deep commitment to improving the lives of people with MS and those who care for them."
- here's the release
Special Report: The top 15 late-stage blockbusters in the pipeline - Plegridy, Biogen Idec