LONDON (Reuters) - 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.
Reporting by Ben Hirschler; Editing by David Holmes