Biogen Idec Inc, the maker of multiple sclerosis drugs Avonex, Tysabri and Tecfidera, boosted its 2013 forecast after Tecfidera sales topped analysts’ third-quarter estimates.

Revenue this year will grow by 23 percent to 25 percent, with adjusted earnings of $8.65 to $8.85 a share, the Weston, Massachusetts-based drugmaker said today in a statement. The company previously had projected revenue gaining 22 percent to 23 percent and adjusted earnings of $8.25 to $8.50 a share.

TECFIDERA WAS DERIVED FROM AN OLD BASIC CHEMICAL: FUMERIC ACID, USED TO MAKE FOODS TASTE SOUR & TO PRESERVE THEM! 


Dimethyl fumarate has been used to prevent mold from growing on furniture during shipping from China. The chemical was implicated in cases of skin rashes in Europe, where dimethyl fumarate is now banned from consumer products.

There aren't very many drugs that are also, essentially, industrial chemicals available in railroad-car volumes...But there are a few. One is lithium carbonate, a staple of glassmaking and ceramic glazes and also the active ingredient in drugs for depression. Another is nitrous oxide, or laughing gas, for anesthesia.

Then there's Tecfidera, or dimethyl fumarate, which was approved by the Food and Drug Administration in March to treat multiple sclerosis. The twice-a-day pill from Biogen Idec was derived from an old, basic chemical: fumaric acid, used industrially to make foods taste sour and to preserve them.

ECTRIMS Congress 2013: New TECFIDERA Data Show Sustained Efficacy and Long-Term Safety in a Broad Range of Multiple Sclerosis Patients

 ECTRIMS Congress 2013
Data presented today show that TECFIDERA® (dimethyl fumarate) continues to offer consistent and strong efficacy combined with a favorable safety profile in a broad range of patients with relapsing-remitting multiple sclerosis (RRMS), including those patients who are newly diagnosed with the disease. These data were presented by Biogen Idec (NASDAQ: BIIB) at the 29th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Copenhagen, Denmark from 2-5 October.

“Because MS is a chronic, life-long disease, physicians and patients need to know they are taking a treatment that will offer them sustained efficacy over the long-term with a consistent safety profile”

ECTRIMS Congress 2013: Biogen covers all bases for personalised approach to MS

 ECTRIMS Congress 2013

After presenting fresh data on products old and new, Biogen Idec believes that a more personalised approach to treating multiple sclerosis is the future.

The company is making over 55 presentations at the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) congress in Copenhagen and unsurprisingly data on its oral treatment Tecfidera (dimethyl fumarate) has taken centre-stage.

Interim analyses from the ENDORSE long-term extension study show that Tecfidera maintained its effect in reducing disease activity in patients treated for four years. Furthermore, no new or worsening safety signals were observed in patients who had been on the drug for up to six and a half years.

In addition, a separate analysis of the Phase III DEFINE and CONFIRM trials reveals that the drug significantly reduced MS relapses in treatment-naive patients, while delaying the overall progression of the disease.

The data is going to do no harm to Tecfidera's already-impressive sales. The drug was only launched in March in the USA (Biogen is still waiting for European approval and would not comment on when that may be) but there has been a huge uptake across the pond, notably among new MS patients.

Biogen has also been presenting fresh data on its blockbuster Tysabri (natalizumab) which showed that use of the drug beyond two years continued to  reduce disability progression and maintained very low relapse rates. Alfred Sandrock, chief medical officer, noted that the analyses also "build upon a growing body of evidence that demonstrates greater clinical benefits for people with MS when Tysabri is initiated earlier".

Data is also being presented on Biogen's investigational MS drugs, such as Plegridy (pegylated interferon beta-1a), the pegylated version of its older blockbuster Avonex and daclizumab, a once-monthly subcutaneous injection being developed with AbbVie.

ECTRIMS Congress 2013: Biogen Idec's new multiple sclerosis drug Tecfidera remained effective for patients taking the medicine for at least 4 years with no new safety problems

 ECTRIMS Congress 2013
Biogen Idec's hot-selling new multiple sclerosis drug Tecfidera remained effective for patients taking the medicine for at least four years with no new safety problems, according to interim data from a long-term study presented on Friday at ECTRIMS in Copenhagen.

In addition, there were no new or worsening safety problems observed even in patients taking Tecfidera for up to six and a half years, according to the interim analysis presented on Friday at ECTRIMS

Tecfidera, which analysts expect to eventually dominate the MS market, had sales of $192 million in its first quarter on the market - nearly triple average Wall Street expectations.

The Endorse extension study followed patients who had taken part in two pivotal Phase III trials that led to the U.S. approval of Tecfidera.

The drug maintained its ability to reduce disease activity as measured by relapses and disease progression in patients treated for four years, the interim data showed.

Patients in the extension study also experienced a low frequency of new MS brain lesions similar to what had been observed after two years.