BG-12 Summary

[Marco]

I am attempting to summarize what I know about BG-12 and answer some of the more common questions that I have seen. I have not been involved in the BG-12 trials, have no relationship to Biogen and claim no medical (or any other) expertise.


What is BG-12?
BG-12 (dimethyl fumarate or DMF) is an experimental oral drug for treating relapsing-remitting multiple sclerosis (RRMS).

Who makes BG-12?
Biogen that also manufactures Avonex and Tysabri both MS disease modifying drugs.

Is BG-12 new?
DMF used for for MS treatment would be a new. DMF is a Fumaric Acid Ester (FAE) and has been used in the treatment of psoriasis since 1959. Since 1994, DMF has been sold in Germany under the name Fumaderm for psoriasis treatment.

Is the drug approved?
BG-12 has been submitted to the US Food & Drug Administration, European Union, Canada and Switzerland for approval. The drug was submitted to the US FDA on February 28th and has been granted "fast track" status. The US FDA BG-12 ruling should come out between Q3 2012 and Q1 2013.

How does the drug work?
Immunomodulatory: BG-12 is thought to help regulate the immune system by changing the immune response.
Neuroprotective: BG-12 partially protects the blood brain barrier and enchances myelin repair.
Anti-inflammatory: BG-12 is thought to decrease central nervous system inflammation.

How is BG-12 administered?
BG-12 is an oral medication that has been tested taken 2 or 3 (BID or TID) times/day.

What BG-12 MS trial have been conducted?
Two Phase III studies have been conducted with names "DEFINE" and "CONFIRM" both having over 1,000 patients

What were the trial results?

Taken twice daily (BID)
53% annual reduction in relapse rate
44% relapse rate reduction at 24 months
21% reduction in disease progression
38% reduction in disability progression
85% reduction in the mean number of new or newly enlarging T2 hyperintense lesions
90% reduction in galadium enhancing lesions
72% reduction in T1 hypointense lesions

Taken thrice daily (TID)
48% annual reduction in relapse rate
51% relapse rate reduction at 24 months
24% reduction in disease progression
34% reduction in disability progression
74% reduction in the mean number of new or newly enlarging T2 hyperintense lesions
73% reduction in galadium enchanging lesions
63% reduction in T1 hypointense lesions

What about side effects?

The serious or adverse events for patients on BG-12 and placebo were statistically similar.

Common side effects have been:
Flushing in 38% of BID and 32% of TID patients
Upset stomach, diarrhea, nausea and abdominal pain
Headache

The studies revealed a decrease in side effects for most patients after one month on therapy. Fumaderm users have noted similar side effect reductions after increased use.

What will BG-12 cost?
Biogen hasn't released this information, but BG-12 will probably be in-line with other MS therapies (expensive).

Will there be a financial assistance program?
This also is unknown, but Biogen has assistance programs in place for both Avonex and Tysabri.

[Sara Angela]

Thanks for posting this information!!

Sara

[knuckle]

Evidently, Dimethyl Fumarate is also being studied for Lupus, Rheumatoid Arthritis, and even Cancer.

Fumaric Acid, from which Dimethyl Fumarate is derived from, has also been found effective against these same autoimmune diseases.

Try googling: fumaric acid cancer

Fumaric Acid is part of the Citric Acid Cycle, the way our cells make energy. The Citric Acid Cycle requires vitamin D to function correctly.

Malic Acid is also part of the Citric Acid Cycle. You get lot's of Malic Acid from fruits, specifically apples. Apples have always been known to be good for skin complexion and oral health due to their high Malic Acid content.

Apple Cider Vinegar has long been used as a home remedy for Psoriasis, Rheumatoid Arthritis, Fibromyalgia, even MS. Malic Acid has been clinically shown to increase energy and reduce pain associated with Fibromyalgia.

The side effects of taking too much Fumaric Acid, Malic Acid and Apple Cider Vinegar are pretty much the same: flushing and gastro issues.

BG12, Dimethyl Fumarate, is "thought" to work by having an immuno-modulatory effect. What modulates the immune system?

Endorphins. Endorphins modulate the immune system by regulating T-cell proliferation. Endorphins are Hormones. Hormones effect MS progression - a reason why MS progresses differently in men and women and by age.

How do you produce endorphins? Through direct sunlight on your skin, vitamin D supplements/food, spices, exercise, pleasure (sex, music, art, etc.) and...Low Dose Naltrexone (LDN).

People who live in parts of the world where they eat lot's of oily fish rich in vitamin D, get lot's of sun, eat lot's of spices, all have low rates of autoimmune disease, like MS. Eskimos don't get MS. People in Asia rarely get MS.

The spices, Tumeric (Curcumin), Cinnamon and Saffron are all being currently researched as MS treatments.

One of the positive side effects reported by people in the BG12 trials was increased energy and reduced pain. This makes sense because endorphins, as hormones decrease pain and increase pleasure. A "runner's high" is a good example.

We all also know that vitamin D supplementation and exercise are usually recommended by neurologists for MS.

The high efficacy results of BG12 seem to support that immuno-regulation is a more effective treatment than immuno-suppression. Further, BG12 validates the anecdotal success of people who take LDN for MS as well as other autoimmune diseases and cancer.

BG12 produces endorphins through the Citric Acid Cycle. LDN produces endorphins by blocking the Pituitary Gland for 2-4 hours and causing a 2-300% over-production of endorphins for the next 20 hours or so.

It sure looks to me like Endorphins are key to controlling MS, other auto-immune diseases, and cancer, which is pretty revolutionary.

I would also go so far to say that since more women than men acquire MS, and that LDN has been shown more effective in women, especially pre-menapause, that BG12 will have higher efficacy in younger women.

[Thomas Jackson]

Thanks Marco for the onfo.

[gardeningb]

Thanks Marco!

Just one thing with regard to the cost.

My neuro said that as this is compoundable just like LDN, it would be robbery of all MSers if Biogen choose to charge more for this drug. He said should it be approved and they choose to overcharge he will send my scrip out to a compounding pharmacy. Not sure of the legalities, but my insurance only covers 50%, so if he can do it then I would go with it. I am grateful for the assistance programs and understand the complexities of interferons, but that should not be the case with BG12 as it is not with LDN.

[ijustcallit]

I thought BG 12 would be available this summer. How long can this take????!!!!

[hunterd]

Thank you for the information Marco. As always, you were on top of things. Posting that information was very useful to many.

[Tomjadg]

Thanks for the info.
This should be available by my 2 year point taking Ty.

Although I don't expect much, I will switch to BG to get away from the PML issue. This will save some time with the infusions each month also.

[Marco]

I thought BG 12 would be available this summer. How long can this take????!!!!

The 1992 Prescription Drug User Fee Act (PDUFA) established a two-tiered system – Standard Review and Priority Review.
- Standard Review is applied to a drug that offers at most, only minor improvement over existing marketed therapies. The 2002 amendments to PDUFA set a 10 month goal for a standard review.
- Priority Review designation is given to drugs that offer major advances in treatment, or provide a treatment where none existed. The goal for completing a Priority Review is six months.


On February 28th, Biogen submitted the request for FDA approval so a summer availability is rather optimistic. After FDA approval, insurance companies will review the drug benefits and costs before including it on their formulary. Time frames will vary widely from one insurance company and even from one plan to the next.

Then add time for you to see your neurologist, for your neurologist to submit the prescription, for your insurance company to review and approve the prescription. Once approved, you'll most likely need to coordinate delivery with a specialty pharmacy and finally you can ingest your first BG-12 dose.

I am trying to be realistic about this instead of pessimistic. I did make a little sign for my neurologist that reads "All I Want For Christmas Is My BG-12." I just hope Santa has me on the correct gift list.

[woodstock]

Thank you Marco for the BG-12 summary. I really wish we could get similar summaries for the other CRABS. It would make it much easier to sift through all the information out there.

[martypdji]

The data seems like taking it twice a day is more effective than taking it three times a day. Or at least the same result, with the margin of error favoring the two pills a day people. Am I the only one seeing this? What are your thoughts about this?

[knuckle]

Because the way the body produces Endorphins are in "surges" not evenly over time. Like LDN, the more you take of BG12 the more the the body will get used to it's effect and doesn't respond as intensely.

If you took BG12 four-to-five times a day it's efficacy would probably be even less.

[labms]

I am happy to find this information since my nero said today that BG-12 might be the next move for me so I am hopeful to hold out with copaxone until it comes out. Thanks!

[golfore]

What is the cost of Gilenia?

I'm on TY and the cost is $4,000-$6000 every 4 weeks. That's EXPENSIVE!

I thought that Gilenia was much less expensive. I guess my question is, why would something like BG-12 be expensive if it has been around since 1955?

Am I missing something?

[futurmil2b]

I don't visit this site too often but I glad I came across this information. My last visit with my Neuro he told me he had some good news... he was telling me about B-12.. he said it should be out SOON. If it helps with my muscle tightness, I AM ALL FOR IT :0)

He said it has little side effects... I am sure they say that about all new meds that come out... But this one sounds like it has great potential. I always said there is a cure for MS. Cancer, almost any diseases.. they just have not stumbled upon it yet.

HOPEFULLY.. B-12 WILL BE THE KEY IN TREATING MS :0) WITH LITTLE TO NO SIDE EFFECTS!!!!! Let us join hands and hearts and PRAY...

Ms. Jay