Going well beyond the standard sponsor-CRO relationship, Biogen Idec has recruited Quintiles to revamp its clinical development process, giving the contractor a seat at the R&D table to improve trial efficiency.
Launched last April, Tecfidera racked up more than a half-billion dollars in sales for the first quarter of this year. That puts its cumulative total at $1.38 billion--well within blockbuster territory.
With a pair of long-acting hemophilia meds on the way, Biogen Idec appears poised to shake up the market for the bleeding disease. And though recently approved Alprolix has yet to launch, it has already made waves: Biogen has priced it on par with older therapies, leaving competitors vulnerable to patient-switching.
Biogen Idec's long-acting hemophilia A drug performed well in a late-stage study on children, the biotech said, giving it another Phase III victory as it races with rivals Bayer and Novo Nordisk to launch a more convenient treatment for the bleeding disorder.
New, long-acting hemophilia therapies are preparing to take the market by storm. For patients, they'll require less frequent infusions, proving more convenient. But for current market leaders like Baxter International, they could put millions in jeopardy as they take hold of the global markets for hemophilia A and B, worth a combined $7 billion.
Biogen Idec now has FDA approval for Alprolix, the first in a new wave of long-acting hemophilia treatments on their way to market. For Biogen, the thumbs-up is an opportunity to grab market share with a hemophilia B product that works three times as long as current clotting factors. But what will the ensuing market battle mean for Baxter?
Late on Friday the FDA announced that it had approved Biogen Idec's long-acting hemophilia B drug Alprolix, setting the stage for a rough-and-tumble showdown among the new and old generations of drugs competing for the blockbuster market.
George Scangos, CEO of biotech powerhouse Biogen Idec, and David Page, director of MIT's Whitehead Institute for Biomedical Research, have made a $5.3 million handshake, the Boston Globe reports, as the two institutions plan to collaborate on early-phase development.
With the departure of Astellas and now Biogen Idec, Aveo Oncology is fresh out of collaborators, sending the struggling biotech back to the partnering table as it looks to advance an early-stage cancer drug.
In the race to win FDA approval for a long-acting hemophilia A treatment, Novo Nordisk said its factor VIII therapy came through in a Phase III study, helping the Danish drugmaker play catchup in a three-way contest with Biogen Idec and Bayer.