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Plegridy approval underlines Biogen Idec's dominance in MS

And Tecfidera boosts pharma company’s second quarter financial results
Biogen Idec building

Biogen Idec added a fifth product to its multiple sclerosis (MS) franchise last week after the European Commission approved long-acting interferon Plegridy.

Plegridy (peginterferon beta-1a) is a long acting treatment for relapsing-remitting multiple sclerosis (RRMS) in which interferon beta-1a - the active ingredient in Biogen's Avonex - is pegylated to make the drug last longer in the body than other beta interferons.

This includes Avonex, which is one of Biogen's leading products, pulling in sales of around $3bn last year. However, the drug is starting to show its age in the face of competition from oral MS therapies, and Plegridy now stands as an attractive alternative.

The new drug is dosed once every two weeks - compared to once a week for Avonex - and is the only pegylated version of interferon beta on the market. It has also been filed for approval in the US but an FDA delay has put back a possible approval date from March to this summer.

Plegridy's dosing gives Biogen Idec a competitive advantage over Avonex rivals such as Bayer's Betaferon/Betaseron (interferon beta-1b) and Merck Serono/Pfizer's Rebif (interferon beta-1a), and also beefs up the firm's marketplace battle with Teva's Copaxone (glatiramer acetate), which was recently approved in a new less-frequent dosing regimen (three times a week).

Tecfidera boosts financial performance

News of the approval came as Biogen Idec reported spectacular second-quarter results driven mainly by the company's oral MS drug Tecfidera (dimethyl fumarate), which added $700m to its coffers - tripling its turnover in the US - and is on track to reach peak sales of up to $6bn, according to some analysts.

Avonex sales in the second quarter were flat at around $774m, while its other major MS drug Tysabri (natalizumab) grew 37 per cent to $533m thanks to approval in Japan and roll-out in Italy.

Biogen Idec and partner AbbVie recently reported positive top line results from a phase III trial of daclizumab HYP (high yield process) as a once-monthly, subcutaneous therapy for relapsing-remitting MS and a marketing application dossier is in the process of being drawn up.

Meanwhile, the company should have data from a phase III trial of Tysabri in secondary-progressive MS in the coming months, potentially expanding the use of the drug.

If all goes according to plan Biogen Idec will eventually have "six important medicines to offer MS patients with different needs," said chief executive George Scangos last week, who said that - despite the availability of oral therapies for MS - interferons will continue to play a key role in therapy.

Biogen Idec is also developing BIIB033, an anti-LINGO-1 antibody for MS, which is currently in phase II trials to see if it can halt demyelination of nerves in active relapsing MS patients, as well as people with an ophthalmic condition called acute optic neuritis.

Scangos also said that Biogen Idec's new long-acting haemophilia drugs Alprolix (Factor IX Fc fusion protein; eftrenonacog alfa) and Eloctate (Factor VIII Fc fusion protein; efraloctocog alfa) are now both on the market and initial signs indicate they are performing well.

Alprolix has made around $10m in sales since its launch in May, while Biogen Idec has no figures yet for Eloctate, which launched earlier this month.

28th July 2014

From: Sales, Regulatory



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