Biogen Idec races to FDA and EMA with a blockbuster app for BG-12

Biogen Idec has filed an NDA on BG-12, taking another step forward in its blockbuster quest to gain an approval on its best near-term hope for a game-changing new treatment. Biogen ($BIIB) racked up promising late-stage data on the program, giving the company good odds for achieving an ultimate OK from the FDA. And the Cambridge, MA-based biotech is putting the final touches on an EMA submission aimed at redefining the market for MS drugs in Europe.

BG-12 is a "real potential blockbuster in the space," Biogen R&D chief Doug Williams tells FierceBiotech. "The safety profile is really quite good, and the benefit/risk profile is really positive."

Biogen is hoping to land a priority review for the treatment, says Williams, which would shave four months off the standard 10-month regulatory cycle. But even if it doesn't, the developer can be upbeat about its prospects for an approval in late 2012 or early 2013. For Biogen Idec, which plans to spend about a quarter of its revenue on R&D this year, the ability to look forward to major league approvals gives the big biotech company some critical leeway with analysts.

"We think BG-12 is going to be a very successful drug in the marketplace," says Williams. "In this business, you have to make consistent investments in R&D over a period of time. That has paid off."

Speed is of the utmost importance right now. Novartis ($NVS) made it to the MS market first with Gilenya. Now the analysts expect that BG-12 will move in to snag significant market share. And if Biogen does nail down key approvals early, they'll continue to cast a shadow over Sanofi's ($SNY) big plans for Lemtrada, the experimental MS drug obtained in the Genzyme buyout.

Williams notes that while there's no head-to-head data with Gilenya, BG-12 can compete on data demonstrating "extremely strong disease control activity across a broad range of parameters."

- here's the press release

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