Feb 3 Biogen Idec Inc's high profile
new multiple sclerosis drug Tecfidera won European approval, the
company said on Monday, opening the door for its launch in one
of the world's largest markets for MS treatments.
The approval was widely expected after the European
Medicines Agency endorsed the drug in November. European health
regulators typically follow EMA recommendations within a couple
Tecfidera will be the third oral MS drug available in
Europe. However, if its impressive early performance in the
United States is any indication, the Biogen drug is likely to
surpass sales of Novartis' Gilenya and Aubagio from
Tecfidera has consistently shattered Wall Street sales
forecasts and is well on the way to racking up more than $1
billion in sales in its first year on the market.
Biogen reported Tecfidera sales of $398 million for the
fourth quarter of 2013, only the medicine's third full quarter
since winning U.S. approval. It is also approved for sale in
Canada and Australia.
The introduction in Europe will start in the coming weeks,
although its full roll-out will take place over the course of
this year and next as Biogen must negotiate reimbursement for
the treatment on a country by country basis.
First up will be Germany, "where you can get pricing
reimbursement rather quickly," Tony Kingsley, Biogen's head of
global commercial operations, said in a telephone interview.
"We're ready to go," said Kingsley, adding that Biogen's
Germany sales force for the new drug has been in place for
Tecfidera's prospects in Europe had been in doubt at one
stage because of uncertainty about protection against generic
copies. This issue was resolved in November when Biogen won 10
years of regulatory exclusivity.
There are an estimated 400,000 people in Europe with
multiple sclerosis. Biogen declined to comment on what type of
market share Tecfidera was likely to seize in Europe.
"We're very encouraged by our U.S. experience," Kingsley
Robert W Baird analyst Christopher Raymond forecast 2014
Tecfidera sales outside the United States of $291 million.
Looking further ahead, analysts on average forecast annual
worldwide sales of the drug reaching some $6 billion by 2019,
with more than a third of that coming from Europe and other
non-U.S. markets, according to consensus forecasts compiled by
Thomson Reuters Pharma.