May 30 Biogen Idec Inc expects a delay
in the European launch of its multiple sclerosis drug Tecfidera
as the drugmaker works to secure exclusive data that could
potentially protect its treatment from generic competition for a
Biogen said in a filing it was working to make the drug's
regulatory data protection clearer prior to the launch, and
expects the European launch to be delayed until the second half
The company's shares were down about 1 percent in premarket
trade. They closed at $238.99 on Wednesday on the Nasdaq.
"The company does have a granted patent in EU which would,
in theory, protect the compound, until 2028. However, the patent
is not a 'compound' patent and thus could be challenged," ISI
Group analyst Mark Schoenebaum said in a note.
Apart from patents, the European regulators also grant a
"new active substance" (NAS) designation that can protect new
drugs from generic competition.
Without this designation, generic copies of a drug can be
launched in Europe in as little as three years.
"Biogen has said repeatedly that they believe (Tecfidera)
should qualify for 10 years of protection, although it might not
be through the NAS designation," Schoenebaum said.
"We suspect this pathway is exactly what Biogen is
discussing with the EU regulators now," he added.
Tecfidera, which is expected to receive European regulatory
approval this quarter, was recommended for European approval in
March, along with Sanofi's MS pill Aubagio.
However, EU regulators declined to give Aubagio the NAS
designation because it is similar to an older drug, an action
that could hurt sales of other MS drugs on the market as well.
Biogen launched Tecfidera in the United States earlier this
The drug is widely seen as its most important growth driver,
with estimated 2013 sales of $300 million and eventual peak
sales of $3 billion.