LONDON, March 25 Uncertainty over European
exclusivity for Sanofi's new multiple sclerosis (MS)
pill Aubagio could disrupt the wider market and impact other
companies, according to a leading industry analyst.
The French drugmaker won an approval recommendation on
Friday for the medicine from the European Medicines Agency, but
the regulator refused to give it a "new active substance" (NAS)
designation because it is very similar to a much older drug.
Without this designation, Tim Anderson of brokerage
Bernstein said generic copies could be launched in Europe in as
little as three years - the time required for brief clinical
studies of generics and to review applications for approval.
That might not be a disaster for Sanofi, since most of the
drug's sales are expected to come from the United States, but
Anderson said in a research note it could wreak "havoc" on the
rest of the European MS market because of the price disparity
that would suddenly exist between generic Aubagio and rivals.
Products that could be hit include injectable MS drugs like
Teva's Copaxone and Biogen Idec's Avonex and
Tysabri, as well Novartis's MS pill Gilenya. It could
also hurt Biogen's new tablet, known as Tecfidera or BG-12,
which was recommended for approval in Europe last week.
Sanofi said it was very disappointed by the European
regulator's decision on the NAS designation for Aubagio and
planned to request a re-examination of the case.