BG-12 also met magnetic resonance imaging (MRI) endpoints in a cohort of patients, demonstrating a significant effect on MS brain lesions. Reductions in new brain lesion counts were evident within the first year of treatment and were sustained throughout the study. At two years compared to placebo:
- BG-12 reduced the number of new or newly enlarging T2-hyperintense lesions (secondary endpoint) by 71 percent for BID (p<0.0001) and by 73 percent for TID (p<0.0001), while GA provided a 54 percent reduction (p<0.0001).
- BG-12 reduced the number of new non-enhancing T1-hypointense lesions (secondary endpoint) by 57 percent for BID (p<0.0001) and by 65 percent for TID (p<0.0001), while GA provided a 41 percent reduction (p=0.0021).
- BG-12 reduced the odds of having more gadolinium-enhancing (Gd+) lesions (tertiary endpoint) by 74 percent for BID (p<0.0001) and by 65 percent for TID (p=0.0001), while GA provided a 61 percent reduction (p=0.0003).
- Adverse events (placebo 92%; BG-12 BID 94%; BG-12 TID 92%; GA 87%)
- Serious adverse events (placebo 22%; BG-12 BID 17%; BG-12 TID 16%; GA 17%)
- Discontinuations due to AEs (placebo 10%; BG-12 BID 12%; BG-12 TID 12%; GA 10%)
Mean lymphocyte counts decreased during the first year of BG-12 treatment and then plateaued, staying within normal limits throughout the entire treatment period. The incidence of hepatic and renal events was comparable among all study groups. The incidence of serious infections was low and balanced across the study groups, and there were no opportunistic infections. In CONFIRM, there were no malignancies in the BG-12 groups, one malignancy in the placebo group and four malignancies in the GA group.“Results from CONFIRM are similar to what was observed in DEFINE, providing favorable safety data from these two substantial global studies,” said J. Theodore Phillips, M.D., Ph.D., program director of the Multiple Sclerosis Program at the Baylor Institute for Immunology Research, clinical professor of Neurology at the University of Texas Southwestern Medical Center, and investigator in the CONFIRM study. “The most common BG-12 side effects were flushing and GI events, which decreased substantially in incidence after the first month and resulted in a low incidence of discontinuations.” These data will be presented in three platform presentations at the AAN annual meeting:
- Clinical Efficacy of BG-12 in Relapsing-Remitting Multiple Sclerosis (RRMS): Data from the Phase 3 CONFIRM Study (S01.003) will be presented by Dr. Robert J. Fox on Tuesday, April 24, 2012 from 1:30-1:45 p.m. CDT
- Effects of BG-12 on Magnetic Resonance Imaging (MRI) Endpoints in Patients with Relapsing-Remitting Multiple Sclerosis (RRMS): Data from the Phase 3 CONFIRM Study (S11.001) will be presented by Dr. David Miller of the University College London’s Institute of Neurology, on Tuesday, April 24, 2012 from 3:00-3:15 p.m. CDT
- Safety and Tolerability of BG-12 in Patients with Relapsing-Remitting Multiple Sclerosis (RRMS): Analyses from the CONFIRM Study (S41.005) will be presented by Dr. J. Theodore Phillips on Thursday, April 26, 2012 from 2:00-2:15 p.m. CDT
For members of the media interested in more information and additional resources, please visit www.biogenidec.com/us_media_corner.About the CONFIRM Clinical Trial The CONFIRM ( Comparator and a n Oral Fumarate in RR MS) clinical trial was a global, randomized, double-blind, placebo-controlled, dose-comparison study to determine the efficacy and safety of BG-12 and enrolled 1,430 people with RRMS. The study evaluated two dose regimens of BG-12, 240 mg BID and 240 mg TID, as well as a reference comparator of GA (20 mg subcutaneous daily injection). Both BG-12 and GA groups were evaluated versus placebo. The primary objective was to determine whether BG-12 was effective in reducing the rate of clinical relapses at two years. Secondary objectives at two years included reduction in the number of new or newly enlarging T2-hyperintense lesions; in new non-enhancing T1-hypointense lesions; in the proportion of patients who relapsed; and in progression of disability as measured by EDSS. Safety and tolerability of BG-12 were also assessed. About BG-12 BG-12 (dimethyl fumarate) is an investigational oral therapy in late-stage clinical development for the treatment of relapsing-remitting multiple sclerosis (RRMS), the most common form of MS. BG-12 is the only currently known investigational compound for the treatment of RRMS that has experimentally demonstrated activation of the Nrf-2 pathway. In 2011 and 2012, Biogen Idec announced positive data from DEFINE and CONFIRM, two global, placebo-controlled Phase 3 clinical trials that evaluated 240 mg of BG-12, administered either twice a day or three times a day, for two years. Applications for marketing authorization for BG-12 were submitted by Biogen Idec by the FDA and the EMA in the first quarter of 2012. About Biogen Idec Through cutting-edge science and medicine, Biogen Idec discovers, develops and delivers to patients worldwide innovative therapies for the treatment of neurodegenerative diseases, hemophilia and autoimmune disorders. Founded in 1978, Biogen Idec is the world’s oldest independent biotechnology company. Patients worldwide benefit from its leading multiple sclerosis therapies, and the company generates more than $5 billion in annual revenues. For product labeling, press releases and additional information about the company, please visit www.biogenidec.com. Safe Harbor This press release includes forward-looking statements, including statements about the commercialization of BG-12 in MS. These forward-looking statements may be accompanied by such words as "anticipate," "believe," "estimate," "expect," "forecast," "intend," "may," "plan," "will" and other words and terms of similar meaning. You should not place undue reliance on these statements. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including obtaining regulatory approval, the occurrence of adverse safety events, product competition, the availability of reimbursement for our products, adverse market and economic conditions, problems with our manufacturing processes and our reliance on third parties, failure to comply with government regulation and possible adverse impact of changes in such regulation, our ability to protect our intellectual property rights and the cost of doing so, and the other risks and uncertainties that are described in the Risk Factors section of our most recent annual or quarterly report and in other reports we have filed with the SEC. These statements are based on our current beliefs and expectations and speak only as of the date of this press release. We do not undertake any obligation to publicly update any forward-looking statements.