Biogen Idec's Tecfidera clears first major regulator hurdle
This article was originally published in Scrip
Executive Summary
News in a Nutshell
News in a Nutshell
Biogen Idec's Tecfidera (also known as BG-12 or dimethyl fumerate) looks likely to win European marketing approval. The committee that examines the approvability of drugs in the European Union has adopted a positive opinion of the multiple sclerosis product, paving the way for its approval in approximately two months. No serious safety issues were mentioned.
Indication and dosing details
The Committee for Medicinal Products for Human Use (CHMP) has backed the marketing authorization of Tecfidera 120mg and 240mg oral gastro-resistant hard capsules as a first-line treatment for adult patients with relapsing remitting multiple sclerosis. In the two clinical trials used by the company in its European application, patients received 240mg either twice a day or three times a day for two years.
Panel's summary of benefit
Ability to reduce the number of relapses in patients with relapsing-remitting MS.
Side-effect details
Most common side-effects are flushing and gastro-intestinal events, such as diarrhea, nausea and abdominal pain. Other side-effects included a decrease in mean lymphocyte counts during the first year of treatment, which then plateaued.
Market size
BioMedTracker estimates that Tecfidera will achieve peak sales of $3.5 billion in Europe in 2021, with sales in the US also peaking that year, at $3.4 billion.
Relapsing-remitting MS is the commonest form of the disease, accounting for 85% of cases.
Next steps
Marketing authorization, to be decided by the European Commission, will require implementation of a pharmacovigilance plan for Tecfidera.
Competition
Novartis gained an early lead with Gilenya (fingolimod) as the first oral treatment for MS to reach the market (in 2010 in the US and in 2011 in the EU), generating global sales of $1.2 billion by 2012. However, BioMedTracker's forecast for the drug's peak sales falls far short of Tecfidera's potential, coming in at $2.5 billion worldwide in 2017. There are no head-to-head studies comparing Tecfidera and Gilenya, but analysts cite conversations with healthcare professionals to back up their belief that Tecfidera to become the dominant therapy on the basis of its safety and efficacy profile.
Biogen Idec is already strong in the market with MS treatments Tysabri (natalizumab) and Avonex (interferon beta-1a), so it is likely that Tecfidera will cannibalize some of its existing product sales. Oral therapies are expected to steal significant market share from injectables in the near future, however.
Sanofi's Aubagio (teriflunomide) has also just been granted a positive opinion by the CHMP, following US approval last September. However, it is not expected to get beyond third place in the race for oral therapy domination.
Established therapies include Avonex and Merck KGaA's Rebif (interferon beta-1a) as well as Bayer's Betaseron/Betaferon (interferon beta 1b), and Teva's Copaxone (glatiramer acetate).
Still in the pipeline are Roche/Genentech's Phase II six-monthly intravenous monoclonal antibody (ocrelizumab, a second-generation version of rituximab), to which Biogen Idec is entitled to royalties; Lemtrada (Sanofi/Bayer/BTG/Takeda's alemtuzumab), which is expected to be the subject of a CHMP opinion in the second quarter of this year, while an FDA response to a supplemental Biologics License Application (sBLA) is expected on the fourth quarter; Teva's laquinimod; Biogen Idec's daclizumab and others.
Other markets
The FDA is expected to make a decision on the marketing application for the product in the US in the next few days: it has a PDUFA date of 28 March. Tecfidera is also under review in Australia, Canada and Switzerland.
Investor sentiment
"We did not see a mention of some of the safety adverse events that Street has debated as we head into the US PDUFA date. However, the CHMP news today is simply a press release and not a formal label," said ISI Group analyst Mark Schoenebaum. "Key focus for Biogen Idec continues to be BG-12 [Tecfidera] PDUFA on 28 March."
Biogen Idec's share price was up 1.06% at $178.43 by mid-morning trading on Nasdaq following the EMA's announcement.
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