BG-12 Phase III Results: it is efficacious in subgroups of relapsing-remitting MS

Despite BG-12 being effective in all subgroups of RRMSers European MSers must wait. For how long? #MSBlog #MSResearch

EpubHutchinson et al. Clinical efficacy of BG-12 (dimethyl fumarate) in patients with relapsing-remitting multiple sclerosis: subgroup analyses of the CONFIRM study. J Neurol. 2013 Jun 8.

Background: In the phase 3, randomized, placebo-controlled and active reference (glatiramer acetate) comparator CONFIRM study in RRMSers, oral BG-12 (dimethyl fumarate) reduced the annualized relapse rate (ARR; primary endpoint), as well as the proportion of MSers relapsed, magnetic resonance imaging lesion activity, and confirmed disability progression, compared with placebo.

Objectives & Methods: To investigate the clinical efficacy of BG-12 240 mg twice daily (BID) and three times daily (TID) in MSer subgroups stratified according to baseline demographic and disease characteristics including gender, age, relapse history, McDonald criteria, treatment history, Expanded Disability Status Scale score, T2 lesion volume, and gadolinium-enhancing lesions. 

Results: BG-12 treatment demonstrated generally consistent benefits on relapse-related outcomes across MSer subgroups, reflecting the positive findings in the overall CONFIRM study population. Treatment with BG-12 BID and TID reduced the ARR and the proportion of MSer relapsed at 2 years compared with placebo in all subgroups analyzed. Reductions in ARR with BG-12 BID versus placebo ranged from 34 % [rate ratio 0.664 (95 % confidence interval 0.422-1.043)] to 53 % [0.466 (0.313-0.694)] and from 13 % [0.870 (0.551-1.373)] to 67 % [0.334 (0.226-0.493)] with BG-12 TID versus placebo. Treatment with glatiramer acetate reduced the ARR and the proportion of patients relapsed at 2 years compared with placebo in most MSer subgroups. 

Conclusion: The results of these analyses indicate that treatment with BG-12 is effective on relapses across a broad range of patients with relapsing-remitting multiple sclerosis with varied demographic and disease characteristics.

“The results of this subgroup analysis are in keeping with the overall results. BG-12 is an effective DMT in RRMS.”

George Scangos

“It is a great pity that Biogen-Idec have delayed the launch of the drug in Europe pending a clarification of a legal issue in relation to data exclusivity on the product. I was told at the ENS by a colleague that if successful this would prevent generic equivalents from entering the market by a several years. This decision reflects very badly on Biogen-Idec. They claim to be a company that has MSers interest at heart and they then decide to delay the launch of an effective drug simply for business reasons. Why couldn’t they have launched the drug and sought the clarification in parallel?All the MSologists I spoke to in Barcelona about this were very upset about Biogen’s actions; particularly as the reasons for the delay had not been explained to the community and we have no idea what to tell MSers in our care waiting to go onto BG-12. As I write this I have no idea how long it will take for them to clarify their position and when the drug will become available to MSers in Europe. More galling was the recent announcement of Biogen-Idec’s CEO’s (George Scangos) remuneration package for last year; it was one of the largest in the industry in 2012 ($13.45 million – a 19% increase from $11.33 million he received the previous year). Who said MS was not a profitable industry for Pharma? No wonder Big Pharma’s reputation is in tatters.”

CoI: multiple

About the author

Prof G

Professor of Neurology, Barts & The London. MS & Preventive Neurology thinker, blogger, runner, vegetable gardener, husband, father, cook and wine & food lover.


  • Prof G you are naive. George Scangos has a fiduciary duty to his shareholders and himself as a shareholder. As CEO he has to looks after the assets and future profits of Biogen-Idec. His remuneration package is partially based on the share price. He is not going to do anything to jeopardize the latter. MSers and their needs are way down the pecking order. If you feel so strongly about this I suggest you and your colleagues boycott BG12; there are other options available to you and MSers would look up to you if you explained why. It is time the community said enough, is enough.

  • Sadly and frustratingly I think anon 8.22 has a point, though I'm not sure boycotting the drug would have much effect unless all neuro's joined in, and I don't think their patients would appreciate that – catch 22?

  • Biogen reputably plow over 30% of their profit back into MS research and development. Generic companies have no interest in research and only want to make a quick profit off the back of an ethical R&D based pharma company. Why should Biogen not protect their assets to ensure that they remain committed to furthering cutting end research in MS..Surely Biogen have shown their commitment to MS and investing in future innovative treatments. Obviously they need to make a profit to sustain the company and the significant resources required for further development in the high cost arena of drug development

    • Anonymous Thursday, June 27, 2013 3:35:00 pm

      You are clearly not up to speed on the history of Biogen's pipeline. All four of the products that are making them billions were not developed in house.

      Avonex (IFN-beta-1a), was licensed in from by Rentschler a German company.

      Tysabri (natalizumab), was licensed in from Athena/Elan.

      Tecfidera (BG12), is based on a drug called Fumaderm for psoriasis that was developed and marketed by Fumedica/Hermal a German company. Biogen have now bought Fumaderm.

      Rituxan/Mabthera (rituximab), was invented by Idec a company that Biogen bought hence the name Biogen-Idec. However, Idec had already licensed the drug to Genentech, that is now wholly owned by Roche. This is why ocrelizumab the follow-on drug is being developed by Roche I believe that Biogen will get 25% of ocrelizumab's sales if and when it gets to market.

      So where is this 30% of profits is going?

      I am open to correction, Baminercept, the first lymphotoxin-beta pathway inhibitor, that targets B cell follicles was Biogen's first in-house drug into humans. What happened to it in relation to MS? The trial was pulled just before the first MSer was dosed. Why? I am told that it was too risky. Pity as there is such interesting biology behind this compound. This leaves anti-LINGO; the only in-house innovative drug that Biogen have developed that is in MS. Let's hope it works. If it does Biogen's 30% of profits spent on R&D will have definitely paid off.

      Daclizumab, that is also being developed by Biogen was licensed in from Protein Discovery Labs, that was bought by Abbot now called Abvie. So this one doesn't count.

      Pegylated interferon-beta is a derivative of Avonex; many people would say this is not real innovation.

      So you decide. Has their 30% of investment being so productive?

    • You are confusing discovery with development. Many small companies that discover new chemical entities that show promise in the lab in terms of therapeutic targeting do not have the financial resources to further development that NCE from the proof of concept stage to clinical studies in patients. 95% of developments costs are Bourne at late stage clinical developments stage comprising phase 2 and 3 studies. These studies are inordinately expensive to run as Gavin well knows on account of the significant regulatory nature of clinical development. Given the fact that only about 50% of all phase 3 pharmaceutical sponsored studies lead to a successful regulatory approval companies therefore carry significant financial risk in late stage drug development. Therefore they have a right to protect their asset once its launched onto the market. If no protection was granted then what would be the incentive to develop drugs fully if only a generic company can come and copy the intellectual property and clinical data developed and create poor imitations that have no significant proven safety record? Therefore ethical pharma companies need to make a profit in order to sustain further expensive drug development and provide innovative new drugs that are a step change from the existing treatment paradigm.

  • Biogen will spend at least double the research budget on marketing. No-one is denying the right of Biogen or pharma in general to make a profit, it's the amount of profit that can be debated (BG12 being a case in point). That some are seeking to gouge as much profit as possible from the old generation of poorly effective DMTs by jacking up the price before the new generation of highly effective DMTs properly come on stream casts them in a less benevolant light.

    • The price increase over time is there for all to see and unfortunately for some to pay..not that spurious..Everyone's view has a bias including those of pharma supporters

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