Some of the analysts following Biogen Idec's late-stage oral MS drug BG-12 were nodding in approval today as the big biotech laid out a full set of data that confirms the efficacy already reported without raising any fresh concerns on the safety front. Reuters reports that BG-12 performed about as well whether it was given twice or three times a day, putting it in line to compete for the blockbuster market for new pills that has been forming since Novartis ($NVS) won an approval for Gilenya.
Reuters reports that the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) posted the detailed data on its web site, offering a close look at study results that confirmed the drug's efficacy and safety profile. A total of 16% of the patients taking BG-12 dropped out of the study compared to 13%.
There weren't any nasty surprises in the DEFINE data, which earned an almost audible sigh of relief from analysts like Jefferies' Thomas Wei.
"These data confirm that the efficacy of the twice a day and three times a day arms were numerically very similar in DEFINE, and increase our confidence in the data," noted Wei. "We are particularly encouraged that there is no material difference in discontinuations due to adverse events."
"As of right now, BG-12's overall clinical profile does appear to be shaping up nicely," wrote J.P. Morgan's Geoff Meacham.
Those reviews are key for Biogen Idec CEO George Scangos, who has been making some big turnaround plans for the biotech. While Scangos was recruited long after the company had committed itself to the BG-12 program, a near-term regulatory win will keep his investors in a very good mood as he focuses on earlier-stage programs. Scangos has already brought in his own executive team and recently announced plans to reunite his corporate staff with the R&D team in Cambridge.
Analysts have been highlighting the blockbuster potential of a new wave of oral MS drugs. And BG-12's prospects brightened considerably when Merck KGaA was forced to scrap its late-stage program for cladribine, heading back to the drawing board as it inked new deals on other oral programs and regrouped for a fresh assault.
- here's the story from Reuters