Biogen Idec’s new oral multiple sclerosis (MS) drug Tecfidera is firmly on course for blockbuster sales in its first 12 months on the market after third-quarter sales reached $286m.
Tecfidera (dimethyl fumarate) was only launched onto the market in March, but has already racked up sales just shy of $500m and looks on track to meet analysts’ expectations of more than $3bn at peak.
Overall, Biogen Idec’s revenues for the quarter came in at $1.8n – up 32 per cent – while earnings also rose 23 per cent to $488m. The company has raised its revenue growth targets for the year to somewhere between 23 and 25 per cent.
Tecfidera’s sales surge has come despite the fact that it is the third orally-active MS drug to reach the market after Novartis’ Gilenya (fingolimod) and Sanofi’s Aubagio (teriflunomide), and Biogen Idec’s commercial head Tony Kingsley sounded a note of caution about future sales trends on the firm’s conference call.
“I’m very pleased with the broad adoption and strong uptake of Tecfidera and view it as a positive sign of initial physician acceptance,” he said, but added that in the coming quarter sales growth would “moderate to more closely reflect the underlying patient dynamics of the MS market.”
The company says Tecfidera is now the leading oral MS drug in the US, a massive achievement given that Novartis reported a 63 per cent rise in Gilenya sales to $518m in its third-quarter results, with US turnover for the drug up 44 per cent to $273m. Gilenya was launched in the US towards the end of 2010.
In the third quarter, almost all Tecfidera’s turnover came from the US with just a $2m contribution from Canada, so there should be plenty of upside from its roll-out into markets outside North America.
Europe remains a grey area for the product, however, with Biogen Idec negotiating hard with the EU authorities to try to secure New Active Substance (NAS) status for the drug, something which was denied Sanofi’s rival product Aubagio.
Fears that Tecfidera would start to cannibalise sales of Biogen Idec’s other products seem to have been unfounded. Avonex (interferon beta-1a) slipped slightly to $733m in the third quarter but gained market share in the injectable MS therapy segment.
Tysabri (natalizumab) also put on a good show with sales in excess of $400m, although the underlying trend is hard to gauge given that the tally includes a portion of sales formerly booked by Elan, Biogen Idec’s former partner for the drug.
There was mixed news for Biogen Idec’s R&D pipeline, however. A pegylated version of Avonex called Plegridy could reach the market next year after a filing in May, but the company is facing delays for haemophilia A candidate Eloctate (recombinant factor VIII Fc fusion protein).
The company’s R&D chief Douglas Williams said it is a result of the FDA asking for more information on manufacturing process validation, although he would not be drawn on how long the delay would last.
“We’re not talking about jeopardy to approval here. We’re talking about timelines,” he stressed.