Biogen flags Ph3 success for crucial MS drug
Biogen Idec has managed to impress analysts this morning with an upbeat batch of data from its late-stage study of an oral drug for multiple sclerosis. With its MS franchise on the line as Novartis rolls out Gilenya and Teva readies the release of detailed Phase III data on laquinimod, Biogen ($BIIB) says that BG-12 hit its primary and secondary endpoints for patients taking the drug twice as well as three times a day. The data help to relieve anxieties for close observers of the company, marking a significant advance forward for the company's pipeline as new CEO George Scangos (photo) works to rebuild the biotech's tarnished image.
Details on the data are being kept under wraps, but investigators also say that patients taking the drug experienced a similar side effect profile as the subjects taking a placebo. Biogen now is on track to deliver the results from a second Phase III study in the second half of this year, potentially positioning the company for a run at an approval.
"The significant clinical responses seen in the DEFINE study represent an important step forward in the development of BG-12 for multiple sclerosis," said Douglas Williams, Ph.D., Biogen Idec's EVP of R&D. "We are very pleased with these data and believe that BG-12 has the potential to offer MS patients a highly effective oral treatment option with a strong safety profile."
BG-12 is designed to tamp down the effect of inflammatory cells on the central nervous system as well as potentially protecting CNS cells from oxidative stress and death by activating the Nrf-2 pathway. Biogen shares were up 5 percent this morning. Teva will unveil the data from its successful Phase III study of laquinimod at the 63rd American Academy of Neurology conference in Hawaii.