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New Data From Phase 3 Studies Provide Additional Evidence Supporting Treatment Effect For Oral BG-12 (Dimethyl Fumarate) In Multiple Sclerosis

Analyses of the pooled clinical efficacy results of DEFINE and CONFIRM show that treatment with dimethyl fumarate led to significant reductions in MS relapses and disease progression. At two years compared to placebo, dimethyl fumarate significantly reduced:

  • Annualized relapse rate (ARR) by 49 percent for both BID and TID (p<0.0001 for both)
  • Proportion of patients who relapsed by 43 percent for BID and 47 percent for TID (p<0.0001 for both)
  • Risk of 12-week confirmed disability progression, as measured by the Expanded Disability Status Scale (EDSS), by 32 percent for BID (p=0.0034) and 30 percent for TID (p=0.0059)

In MRI cohorts from DEFINE and CONFIRM, treatment with dimethyl fumarate significantly improved MRI outcomes over two years compared to placebo by reducing:
  • Mean number of new or newly enlarging T2-hyperintense lesions by 78 percent for BID and 73 percent for TID (p<0.0001 for both)
  • Mean number of new non-enhancing T1-hypointense lesions by 65 percent for BID and 64 percent for TID (p<0.0001 for both)
  • Odds of having a greater number of gadolinium-enhancing (Gd+) lesions by 83 percent for BID and 70 percent for TID (p<0.0001 for both)

“These pooled results demonstrate that dimethyl fumarate had a significant effect on measures that MS patients are acutely aware of – the frequency of the relapses they experience and the progression of disability,” said Ralf Gold, Ph.D., professor/chair of the Department of Neurology at St. Josef-Hospital/Ruhr-University in Bochum, Germany. “As a physician who treats patients with MS, the strong results observed in the Phase 3 studies of dimethyl fumarate indicate that it may provide an attractive combination of efficacy, safety and tolerability.”

Pooled DEFINE and CONFIRM efficacy data are included in one platform and two poster presentations:
  • Clinical Effects of BG-12 in Subgroups of Patients with Relapsing-Remitting Multiple Sclerosis: An Integrated Analysis of the Phase 3 DEFINE and CONFIRM Studies was available for viewing on Thursday, Oct. 11, 2012 from 3:30-5:00 p.m. CEST
  • Clinical Efficacy of BG-12 in Relapsing-Remitting Multiple Sclerosis: An Integrated Analysis of the Phase 3 DEFINE and CONFIRM Studies will be presented by Prof. Ralf Gold on Friday, Oct. 12, 2012 at 2:40 p.m. CEST
  • Effects of BG-12 on Magnetic Resonance Imaging Outcomes in Relapsing-Remitting Multiple Sclerosis: An Integrated Analysis of the Phase 3 DEFINE and CONFIRM Studies will be available for viewing on Friday, Oct. 12, 2012 from 3:30-5:00 p.m. CEST

Pooled Safety Results

Safety and tolerability results were pooled from three placebo-controlled studies (DEFINE; CONFIRM; and a Phase 2 dose-ranging study) involving more than 2,400 patients who had received placebo or 240 mg of dimethyl fumarate twice or three times a day. These pooled data were consistent with results presented at previous medical conferences. The overall incidence of adverse events (AEs: 92% placebo, 95% BID, 93% TID) and serious adverse events (SAEs: 21% placebo, 18% BID, 15% TID) was similar for all treatment groups. The most common AEs associated with dimethyl fumarate treatment were flushing and gastrointestinal (GI) events; the incidence of these events was highest during the first month and decreased thereafter.

Mean lymphocyte counts decreased during the first year of dimethyl fumarate 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 (≤2%) and malignancies (<1%) was low and balanced across the study groups. There were no opportunistic infections.

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