Company news: Biogen-Idec, Bristol-Myers Squibb and Pfizer

Share this article:

Biogen-Idec is submitting its multiple sclerosis drug BG-12 for formal FDA scrutiny. The oral treatment is intended for relapsing-emitting MS. The company is also setting the twice- or three-times daily drug before the European Medicines Agency over the next few days. If approved, it would be Biogen's third entry into the space -- the drugmaker also markets Avonex and Tysabri. BG-12 would be only the second of the nine available therapies that is not an injection or an infusion, after Novartis' Gilenya. “There is still a significant unmet need for new and innovative therapies that target the disease in different ways,” Biogen president of R&D Douglas Williams, PhD., said in a statement.

The FDA is being hush-hush about its agenda for an upcoming meeting of its Cardiovascular and Renal Drugs Advisory Committee, set for May 23, but the Sanford Bernstein analyst Tim Anderson, MD, has a strong suspicion that Bristol-Myers Squibb/Pfizer's Eliquis will be discussed. If so, predicted Anderson, this could suggest a delay in the approval of Eliquis beyond its current March 28th PDUFA. That's despite the agency's having granted the investigational drug, which many expect will become the front-frunner in the new crop of blood thinners, six-month priority review status. "Our best guess remains that FDA may be seeking cover," Anderson wrote in an investor note today, given safety issues with Boehringer Ingelheim's Pradaxa, a related drug approved in 2010. Product labeling and claims could also be up for discussion. At any rate, a small delay shouldn't hurt Eliquis' commercial prospects much. Anderson predicts sales of $395M in 2012, ramping to $2.5B in 2015 and $3.7B by 2020.

Share this article:
You must be a registered member of MMM to post a comment.
close

Next Article in Business Briefs

Email Newsletters

MM&M EBOOK: PATIENT ACCESS

Patient access to pharmaceuticals is a tale of two worlds—affordability has improved for the majority, while the minority is hampered by cost, distribution and red tape. To provide marketers with a well-rounded perspective, MM&M presents this e-book chock full of key insights. Click here to access it.

More in Business Briefs

Novartis said to be stepping out of HCV

Novartis is said to have relinquished rights to an investigational hep. C treatment, signaling its exit from the therapeutic space, according to a former partner's announcement.

Monday Moves: September 15

Hires and promotions for manufacturers, regulatory and agencies

Kantar acquires Evidências, expands Brazilian presence

The company's acquisition signals the growing importance of understanding the Brazilian healthcare market and evidence-based healthcare management services.