This Day On The Street
Continue to site right-arrow
This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here
Stocks Under $10 with 50-100% upside potential - 14 days FREE!

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

Stocks in this article: BIIB

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.

2 of 5

Select the service that is right for you!

Action Alerts PLUS
Try it NOW

Jim Cramer and Stephanie Link actively manage a real portfolio and reveal their money management tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
  • Weekly roundups
TheStreet Quant Ratings
Try it NOW
Only $49.95/yr

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
  • Upgrade/downgrade alerts
Stocks Under $10
Try it NOW

David Peltier, uncovers low dollar stocks with extraordinary upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
  • Weekly roundups
Dividend Stock Advisor
Try it NOW

Jim Cramer's protege, David Peltier, identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.

Product Features:
  • Diversified model portfolio of dividend stocks
  • Alerts when market news affect the portfolio
  • Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
Real Money Pro
Try it NOW

All of Real Money, plus 15 more of Wall Street's sharpest minds delivering actionable trading ideas, a comprehensive look at the market, and fundamental and technical analysis.

Product Features:
  • Real Money + Doug Kass Plus 15 more Wall Street Pros
  • Intraday commentary & news
  • Ultra-actionable trading ideas
Options Profits
Try it NOW

Our options trading pros provide daily market commentary and over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.

Product Features:
  • 100+ monthly options trading ideas
  • Actionable options commentary & news
  • Real-time trading community
  • Options TV
To begin commenting right away, you can log in below using your Disqus, Facebook, Twitter, OpenID or Yahoo login credentials. Alternatively, you can post a comment as a "guest" just by entering an email address. Your use of the commenting tool is subject to multiple terms of service/use and privacy policies - see here for more details.
Submit an article to us!


DOW 17,804.80 +26.65 0.15%
S&P 500 2,070.65 +9.42 0.46%
NASDAQ 4,765.38 +16.9840 0.36%

Brokerage Partners

Rates from

  • Mortgage
  • Credit Cards
  • Auto

Free Newsletters from TheStreet

My Subscriptions:

After the Bell

Before the Bell

Booyah! Newsletter

Midday Bell

TheStreet Top 10 Stories

Winners & Losers

Register for Newsletters
Top Rated Stocks Top Rated Funds Top Rated ETFs