Can Biogen Idec ($BIIB) keep the hits coming? The biotech giant's stock has been at the top of the charts among its peers over the past year, helped considerably by its experimental multiple sclerosis drug BG-12's performance in late-stage development. With new Phase III data on the potential blockbuster expected within weeks, analysts told Reuters about some of the key factors that could play a role in the success of oral drug in the MS market.
Biogen, the world's largest provider of MS therapies, is banking on BG-12 to enter the new market for oral drugs against relapses of the nerve-damaging disease, which is most often treated with injected meds. The company's Phase III trial--dubbed DEFINE--impressed earlier this year, showing the drug could reduce annualized relapse rates 53% compared with placebo, Reuters reports. And drug has the potential to offer better safety than Gilenya, Novartis' oral MS pill that gained FDA approval last year.
For BG-12 to keep its positive momentum, the drug has to repeat the success of the DEFINE study with upcoming results from the Phase III trial appropriately named CONFIRM. Analysts will be watching closely for any safety issues in the 1,400-patient study that, even if the drug eventually gets a market green light, could deter doctors from prescribing it and hurt its chances of reaching blockbuster status. Unlike the previous late-stage study, there's also an arm of the newer trial that includes patients on long-approved MS treatment Copaxone.
While some stock pickers have been bullish about Biogen's chances with BG-12, others sound much more skeptical about the drug's prospects ahead of the big data event. BMO Capital Markets analyst Jim Birchenough has nudged clients to sell shares of Biogen before the data arrive. "We believe commercial expectations for Biogen Idec's multiple sclerosis franchise, in particular for BG-12, have been overestimated and that risk to upcoming CONFIRM data has been underestimated," he said, as quoted by Reuters.
Yet with Biogen's stock price up about 10% over the past week, lots of investors appear to be betting on the company's new BG-12 data to keep its streak alive.
- see the Reuters article