Tecfidera: Biogen Idec's winning hand earns the jackpot for approvals

Project name: BG-12
Disease: Multiple sclerosis
Peak sales estimate: $4 billion
Approved: March 27
Company: Biogen Idec

The Scoop:
When George Scangos took the reins at a troubled Biogen Idec ($BIIB) two years ago, he was handed an ace to put up his sleeve. The ace was the development program for a new MS drug dubbed BG-12, which promised to provide a significant new standard of care for patients who have been willing to risk death to find a good treatment option.

To his credit, Scangos and his new executive team executed the program with great zeal, moving steadily to a spring 2013 approval in the U.S.--one of the biggest FDA OKs of the year. 

Biogen has proved just as adept at rolling the drug out as it did in developing the therapy. In just a matter of months it was able to rack up $285 million in sales in the third quarter, well ahead of estimates. With a better safety profile than Novartis' ($NVS) Gilenya, Biogen was also able to clean up by pricing it at a discount to the rival. And with this kind of launch, there's widespread belief that the drug can near or break the $4 billion mark in 2018.

Two big Phase III studies for Tecfidera (dimethyl fumarate), demonstrated that the drug cut the annual MS relapse rate by about half. The twice-daily dose was associated with a drop in new or expanded lesions by 71% to 99%. And there was a 38% reduction in progression to disability.

It's no wonder that Teva ($TEVA) tried, unsuccessfully, to slow Biogen's march to the FDA in a rearguard fight to save what it can of its Copaxone franchise. And while Biogen Idec was passing Novartis in the market fast lane, Sanofi ($SNY) was able to achieve only one MS approval for Aubagio while Lemtrada was spurned by U.S. regulators.

Scangos proved he knows how to play a winning hand in the big biopharma game. Next up: Advancing some of his own new programs toward a regulatory approval. -- John Carroll (email | Twitter)

For more:
Biogen's Tecfidera drives rosy Q3 results, higher forecast
Novartis, Biogen Idec release more strong data on hot-selling MS pills
Biogen's Tecfidera continues to gain ground, pick up market share
Biogen MS pill soars onstage with impressive first-week script numbers

Tecfidera: Biogen Idec's winning hand earns the jackpot for approvals

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