October 29 ,2013 | By Márcio Barra
Tecfidera (dymethil Fumarate), Biogen Idec’s prized multiple sclerosis drug, is fast approaching blockbuster status according to the recently released third-quarter numbers of Biogen Idec’s, beating along the way analyst expectation and pushing Biogen Idec’s net profit up 22%.
For Q3, Tecfidera sales garnered $286.4 million, far higher than the $217.2 million that analysts expected. It is now expected that Tecfidera will reach $3.5 billion in annual revenue by 2016, a no doubt impressive number for a drug that, in its first quarter in the market (the drug was launched in March 2013 in the US), posted $192.1 million in sales. This revenue mark pushed Biogen’s net profit up 22% to $488 million, up from $398 million last year.
The drug is now also the leading oral MS treatment, easily beating its oral competition – Sanofi’s Aubagio (teriflunomide) and Novartis’ Gilenya (fingolimod )- reaching13% of market share its own compared with their combined 12.3%. Tecfidera finds its success in its safety profile. Aubagio carries the risk of liver injury, birth defects and comes along with a boxed warning, and Gilenya, although first to market, has been held back by heart safety concerns. Tecfidera only causes a decrease in a person’s white blood cell count, alongside nausea, vomiting, and diarrhea, which tended to get better over time without stopping the drug. The drug also has a price of $54,900 per patient per year, cheaper than Gilenya ($60,000 per patient per year), but more expensive than Aubagio ($48,000 per year).
Biogen Idec also has a robust patient assistance program in place, with the company offering a year’s worth of Tecfidera for free to patients in the US who have to wait more than two weeks for reimbursement.
As for an Europe release, while the drug was approved in March by EMA’s CHMP, Biogen Idec is currently negotiating with the European Medicines Agency to try to secure New Active Substance (NAS) status for the drug, something which was denied Sanofi’s rival product Aubagio, in order to avoid earlier generic competition.
Tecfidera essentially acts by activating the nuclear factor (erythroid-derived 2)-like 2 (Nrf2) transcriptional pathway, which helps protect nerve cells from damage and inflammation, thus easing multiple sclerosis symptoms like muscle weakness and difficulty with coordination and balance.
Biogen is currently strengthening its sales force and readying its manufacturing supply chain as some drugs near market release, such as Eloctate, an experimental drug for haemophilia (recombinant factor VIII Fc fusion protein), and a pegylated version of Biogen’s own drug Avonex called Plegridy (interferon beta-1a).