PARIS, June 12 Sanofi said its Genzyme
unit had submitted applications to regulators in the United
States and Europe for its Lemtrada multiple sclerosis treatment
as the pharmaceutical group attempts to offset declining revenue
with new drug offers.
Sanofi, which has worked on the drug in collaboration with
Bayer, submitted a supplemental biologics licence
application to the U.S. Food and Drug Administration and a
marketing authorisation application to the European Medicines
Agency for Lemtrada.
Sanofi acquired Lemtrada through its $20.1 billion takeover
of U.S. biotech group Genzyme last year, when it was already
developing MS pill Aubagio. If approved, both drugs could end up
reaching the U.S. and European markets by the end of the year.
Unlike older MS drugs that have to be injected daily or
weekly, Lemtrada is given just once a year.
"I think Lemtrada is going to be completely different than
everything else, which makes it difficult for the market to
assess," Sanofi Chief Executive Chris Viehbacher told Reuters
earlier this year.
Yet some analysts suspect that Sanofi will not glean huge
revenues from MS drugs due in part to competition. Morgan
Stanley is forecasting 1 billion euros ($1.25 billion) in peak
sales for Lemtrada, while Nomura only sees $360 million.