LONDON Nov 22 Biogen Idec has won
regulatory protection for its top-selling multiple sclerosis
drug Tecfidera in Europe, paving the way for its launch in
markets that could account for a large proportion of future
The European Medicines Agency said on Friday it had granted
the oral medicine a "new active substance" (NAS) designation,
securing Biogen 10 years protection through data exclusivity
that will stop generic firms from launching copycat versions.
In March, Tecfidera was approved in the United States and
also recommended for approval in Europe - but its EU launch has
been delayed, pending a resolution of uncertainty over data
Without this protection, Biogen would have to rely on
relatively weak patents relating the drug's use, which analysts
believe might not prevent generic rivals launching cheaper
copies in key markets like Germany.
Tecfidera competes with Novartis' Gilenya and
Sanofi's Aubagio, two other oral therapies for
multiple sclerosis (MS).
Oral treatments have proved a popular alternative to
traditional drug injections for the debilitating neurological
disorder and Tecfidera sales have exceeded market expectations,
reaching $286 million in the third quarter.
Annual sales are expected to reach $4.55 billion by 2018,
according to consensus forecasts compiled by Thomson Reuters
Pharma, with 36 percent of that coming from Europe and other
Tecfidera was launched at a U.S. price of $54,900 per
patient a year. However, a Biogen executive said at a broker
conference last week that Tecfidera might be priced at around
half this level in Europe.