Biogen Idec is backing up its blockbuster expectations for the MS drug BG-12 with a slate of efficacy and safety data gathered in a late-stage study. Readied for a scientific review, Biogen ($BIIB) execs touted the safety profile of the drug, which has proven to be Exhibit A in the biotech's case for a successful turnaround.
"The safety profile has continued to hold up nicely from one study to the next," Doug Williams, Biogen's softspoken R&D chief, tells Dow Jones. Add it all up, he adds, and you'll find compelling reasons why the oral treatment--now under review--"should be front-line therapy for patients."
At two years of therapy patients in the 1400-subject CONFIRM study most frequently had to deal with flushing and some common GI issues like nausea and diarrhea. But incidents of these side effects also quickly dissipated after treatment began. And the control arm also experienced dramatically high rates of adverse events, not at all uncommon in MS. Patients have been willing to subject themselves to significant risks in the past in order to benefit from new treatments.
This is the second batch of late-stage data to be presented to regulators. "Results from CONFIRM complement the profile we have seen for BG-12 throughout its clinical development program, which now includes robust data sets from two global, placebo-controlled Phase III pivotal studies with more than 2,600 multiple sclerosis patients," said Williams.
- here's the press release
- get the Dow Jones report
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